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Active, Recruiting
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Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP II)
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Observational
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Sponsor:
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University of Pittsburgh |
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Collaborators:
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NIH, NIDDK |
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Study Phase:
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Continuation of CRISP I |
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Status:
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Enrolling by invitation only |
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Age Group:
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15-45 |
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Enrollment goal:
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211 |
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Description:
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This study is a continuation of CRISP I to develop and implement studies to test whether imaging techniques can provide accurate and reproducible markers of disease progression in ADPKD patients.
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Website:
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NIH Study Details
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Efficacy and Safety Study of Second-Line Treatment for Hypertension with ADPKD
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Intervention:
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Drug - Candesartan, Cilnidipine, Imidapril |
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Sponsor:
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The Ministry of Health, Labour & Welfare, Japan; Teikyo University |
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Study Phase:
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II |
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Status:
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Recruiting |
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Age Group:
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20-60 |
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Enrollment goal:
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160 |
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Description:
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To compare the safety and effectiveness of combination therapy to control blood pressure in patients with ADPKD whose blood pressure is not controlled under 120/80 with ARB alone. Either ACE or CCB will be added to the regimen and results will be compared to those on ARB alone.
ARB – angiotensin receptor blocker ACE – angiotensin converting enzyme inhibitor CCB – Calcium channel blocker
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Contact:
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Shigeo Horie, MD +81339642497 or shorie@med.teikyu-u.ac.jp
Satoru Muto, MD, PhD +81339642497 or muto@med.teikyu-u.ac.jp |
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Website:
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NIH Study Details
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Effect of Statin Therapy on Disease Progression in ADPKD
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Intervention:
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Drug - Pravastatin |
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Sponsor:
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University of Colorado Denver |
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Study Phase:
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III |
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Status:
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Unknown |
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Age Group:
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8-21 |
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Enrollment goal:
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100 |
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Description:
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To determine the effect of pravastatin treatment on renal and cardiovascular disease over a 3-year study period in children and young adults aged 8-21 years with ADPKD. |
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Contact:
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Melissa Cadnapaphornchai, M.D. 303-724-1690 or pkd.nurse@ucdenver.edu
Linda Perkins 303-724-1690 or pkd.nurse@ucdenver.edu
You may also call toll-free at 1-877-765-9297
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Website:
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NIH Study Details
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The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in ADPKD
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Intervention:
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High or low sodium diet |
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Sponsor:
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Holstebro Hospital, Denmark |
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Study Phase:
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II |
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Status:
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Recruiting |
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Age Group:
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18-65 |
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Enrollment goal:
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25 |
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Description:
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To examine the effect of high and low sodium diets on kidney function and on hormones that affect the kidney. |
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Contact:
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Carolina C. Graffe, M.D. 0045-99125428 or cacan@ringamt.dk |
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Website:
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NIH Study Details |
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CCB Safety Study in Treatment of Hypertension in ADPKD
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Intervention:
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Drugs - Candesartan; Candesartan Cilnidipine; Candesartan non-calcium channel blocker (CCB) |
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Sponsor:
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Kyorin University, Japan |
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Study Phase:
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IV |
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Status:
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Recruiting |
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Age Group:
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20-60 |
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Enrollment goal:
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150 |
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Description:
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To evaluate the safety and efficacy of calcium channel blocker Candesartan alone or with cilnidipine or with non-CCB in treatment of hypertension in ADPKD patients. |
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Contact:
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Eiji Higashihara, M.D. 81-422-47-5511, ext. 5813 or ehigashi@kyorin-u.ac.jp |
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Website:
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NIH Study Details |
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Sirolimus in ADPKD and severe renal insufficiency (SIRENA - II)
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Intervention:
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Drug - Sirolimus |
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Sponsor:
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Mario Negri Institute for Pharmacological Research |
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Study Phase:
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II & III |
| Status: |
Recruiting |
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Age Group:
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18-80 |
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Enrollment goal:
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40 |
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Description:
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The general aim of this study in adults with ADPKD and severe renal insufficiency (GFR 40-15 ml/min/1.73 m2) is to evaluate the safety and efficacy of sirolimus in slowing renal functional decline as compared to conventional therapy. |
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Contact:
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Norberto Perico, M.D. 0039-035-45351 or norbertoperico@marionegri.it |
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Website:
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NIH Study Details |
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Polycystic Liver Disease in kidney transplant
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Intervention:
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Drugs - Tacrolimus, sirolimus |
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Sponsor:
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Mayo Clinic/Wyeth |
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Study Phase:
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II |
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Status:
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Recruiting |
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Age Group:
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18 years and older |
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Enrollment goal:
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68 |
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Description:
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The purpose of this study is to see if one kind of immunosuppressive drug is better for the patient’s polycystic liver disease than another type. |
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Contact:
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Qi Qian, M.D. 507-284-2511 or qian.qi@mayo.edu
Aleisha Chappell 507-266-8493 or chappell.aleisha@mayo.edu |
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Website:
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NIH Study Details |
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Bosutinib for ADPKD
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Intervention:
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Drug - Bosutinib |
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Sponsor:
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Pfizer |
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Study Phase:
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II |
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Status:
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Recruiting |
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Age Group:
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18-50 |
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Enrollment goal:
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275 |
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Description:
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To determine if bosutinib reduces the rate of kidney enlargement in subjects with ADPKD entering the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or equal to 60 ml/min/1.73 m2; To identify a safe and effective dose of bosutinib to be used in future studies. |
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Contact:
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Pfizer Call Center 1.800.718.1021 |
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Website:
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NIH Study Details |
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Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with ADPKD
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Intervention:
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Drug - Tolvaptan |
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Sponsors:
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Otsuka Pharmaceutical Development & Commercialization, Inc. |
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Study Phase:
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III |
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Status:
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Enrolling by invitation only |
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Enrollment goal:
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1,500 |
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Description:
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To demonstrate whether Tolvaptan modifies ADPKD progression as measured by changes from baseline in total kidney volume (TKV) and renal function. |
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Website:
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NIH Study Details
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Observational Study in Patients with Autosomal Dominant Polycystic Kidney Disease (OVERTURE)
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Observational
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Sponsors:
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Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| Status: |
Currently Enrolling |
| Age Group: |
12-70 |
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Enrollment goal:
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3,000 |
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Description:
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The purpose of this study is to collect characteristics of patients with ADPKD across a broad population over time to better undertand disease progression (signs, symptoms and outcomes). Association of total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed. |
| Websites: |
NIH Study Details
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8 Week Study of Tolvaptan Dose Forms in ADPKD (NOCTURNE)
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Intervention:
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Drug - Tolvaptan |
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Sponsors:
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Otsuka Pharmaceutical Development & Commercialization, Inc.; Otsuka Pharmaceutical Co., Ltd. |
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Study Phase:
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II |
| Status: |
Active |
| Age Group: |
18-50 |
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Enrollment goal:
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180 |
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Description:
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To compare the short-term effects of two tolvaptan formulations in patients with ADPKD. |
| Websites: |
NIH Study Details
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Randomized Clinical Trial of Triptolide Woldifii for ADPKD
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Intervention:
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Drugs - Tripterygium wilfordii, Emodin, Losartan |
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Sponsor:
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Nanjing University School of Medicine, China |
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Study Phase:
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II |
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Status:
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Recruiting |
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Age Group:
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15-70 |
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Enrollment goal:
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150 |
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Description:
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To evaluate the effectiveness of Triptolide Woldifii to slow disease progression in ADPKD by monitoring total kidney volume and changes in renal function by magnetic resonance imaging. |
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Contact:
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Yao Xiaodan, Master 00862586030066 or yaoxiadan@hotmail.com |
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Website:
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NIH Study Details
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ADPKD Pain Study
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Intervention:
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Procedure - Videothoracoscopic Splanchnicectomy (VSPL) |
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Sponsor:
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Mayo Clinic |
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Study Phase:
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II |
| Status: |
Recruiting |
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Age Group:
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18 and older |
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Enrollment goal:
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20 |
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Description:
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To evaluate the effectiveness of VSLP procedure for pain management in patients with ADPKD. |
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Contact:
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Marie C. Hogan, M.D., Ph.D. 507-266-1963 or hogan.marie@mayo.edu |
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Website:
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NIH Study Details
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Evaluation of ARPKD and Congenital Hepatic Fibrosis
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Observational
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Sponsor:
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National Human Genome Project (NHGRI) |
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Status:
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Recruiting |
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Age Group:
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6 months – 80 years |
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Enrollment goal:
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300 |
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Description:
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To collect comprehensive data on kidney and liver disease in ARPKD/CHF and follow patients over time to provide the groundwork for more focused studies and novel therapeutic interventions. |
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Contact:
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Patient Recruitment and Public Liaison Office 1- 800-411 1222 or prpl@mail.cc.nih.gov |
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Website:
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NIH Study Details
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Pilot Study of RNA as a Biomarker for ADPKD
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Observational
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Sponsor:
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The Rogosin Institute |
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Study Phase:
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II |
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Status:
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Recruiting |
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Age Group:
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18 and older |
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Enrollment goal:
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40 |
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Description:
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To assess the potential of urine micro-RNAs as biomarkers for characterizing patients with ADPKD compared with patients with other causes of chronic kidney disease. |
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Contact:
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Stephanie Donahue, NP 212.746.1591 or sld9001@myp.org
Ines Chicos, CCRC 212.746.3541 or inc9012@myp.org |
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Website:
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NIH Study Details
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Short-term Renal Hemodynamic Effects of Tolvaptan in subjects with ADPKD
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Interventional
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Sponsor:
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Otsuka Pharmaceutical Development & Commercialization, Inc. |
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Study Phase:
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I and II |
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Status:
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Recruiting |
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Age Group:
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18-70 |
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Enrollment goal:
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27 |
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Description:
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To determine the short-term effects of dose regimens of tolvaptan studied in patients with ADPKD at various levels of renal function. |
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Website:
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NIH Study Details
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Everolimus on CKD Progression ADPK
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Interventional
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Sponsor:
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A. Manzoni Hospital |
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Study Phase:
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II and III |
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Status:
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Recruiting |
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Age Group:
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18 and older |
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Enrollment goal:
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90 |
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Description:
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To evaluate whether the administration of everolimus (1/5 mg/day) can slow the progression of chronic kidney disease in ADPKD patients. |
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Website:
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NIH Study Details
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Lanreotide Augogel in the Treatment of Symptomatic Polycystic Liver Disease (LOCKCYST)
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Interventional
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Sponsor:
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Univerity of Ziekenhuizen Leven / Ipsen |
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Study Phase:
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II and III |
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Status:
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Recruiting |
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Age Group:
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18 and older |
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Enrollment goal:
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62 |
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Description:
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To evaluate the efiicacy and safety of laneotide autogel 90 mg/4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month six to 120mg/4 weeks for non-responders |
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Website:
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NIH Study Details
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Efficacy Study of Water Drinking on PKD Progression (ESWP)
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Observational
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Sponsor:
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Kyorin University |
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Status:
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Recruiting |
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Age Group:
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18-65 |
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Enrollment goal:
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20 |
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Description:
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To evaluate the long-term effect of water diuresis induced by oral water intake on kidney volume and
renal function in ADPKD patients |
| Contact: |
Eiji Higashihara, MD +81-422-47-5511, ext 5813 or ehigashi@ks.kyorin-u.ac.jp
Kikuo Natahara, MD +81-422-47-5511, ext 7445 or kinuta@ks.kyorin-u.ac.jp |
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Website:
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NIH Study Details
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A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients with ADPKD
(Extension of Trial 156-04-251)
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Interventional
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Sponsor:
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Otsuka Pharmaceutical Co., Ltd. |
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Study Phase:
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III |
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Status:
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Enrolling by invitation only |
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Age Group:
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23 to 53 |
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Enrollment goal:
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150 |
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Description:
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To continue ADPKD patients enrolled in Trial 156-04-251 on oral Tolvaptan twice daily. |
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Website:
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NIH Study Details
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Core A: The Hepato/Renal Fibrocystic Diseases Translational Resource
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Observational
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Sponsor:
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University of Alabama at Birmingham |
| Collaborator: |
National Institutes of Diabetes and Digestive and Kidney Diseases |
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Status:
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Recruiting |
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Age Group:
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Up to 35 years |
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Enrollment goal:
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200 |
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Description:
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- To expand their comprehensive clinical database to include information from patients with hepato/renal cystic diseases.
- To identify genetic mutations in children with ARPKD and other hepato/renal cystic diseases.
- To establish a human tissue resource from those with hepato/renal cystic diseases for research studies.
- To develop a comprehensive informational resource for ARPKD and other hepato/renal cystic disease Families.
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Website:
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NIH Study Details
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Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)
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Observational
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Drug - Lanreotide |
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Sponsor:
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Radboud University |
| Collaborator: |
Ipsen Pharmaceutical |
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Status:
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Recruiting |
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Age Group:
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18 to 70 |
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Enrollment goal:
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43 |
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Description:
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To determine the effect of Lanreotide on polycystic liver and kidneys in patients with ADPKD. |
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Website:
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NIH Study Details
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