|
There are currently many clinical trials for polycystic kidney disease patients – each providing help and hope to the 12.5 million people worldwide affected by one of the most common, life-threatening genetic diseases.
Return to the Research Home Page
|
Blood Pressure Regulation Clinical Trials
|
HALT PKD Progression of PKD (HALT PKD)
|
Intervention:
|
Drugs - lisonopril, telmisartan |
|
Sponsor:
|
University of Pittsburgh Medical Center |
Study Phase:
|
III |
| Status: |
Active; enrollment complete |
|
Enrollment goal:
|
1,018 |
|
Description:
|
To assess the effectiveness of anti-hypertensive drugs telmisartan and lisinopril on PKD progression and its cardiovascular complications in two different levels of kidney function, GFR more than 60 mL/min/1/73m^2 and GFR between 25-60 mL/min/1.73m^2. |
| Additional Information: |
The Data Collection Center is now located at the University of Pittsburgh Medical Center. |
| Contact: |
|
| Website: |
NIH Study Details |
|
|
Effect of Statin Therapy on Disease Progression in ADPKD
|
Intervention:
|
Drug - Pravastatin |
|
Sponsor:
|
University of Colorado at Denver and Health Sciences Center |
|
Study Phase:
|
III |
| Status: |
Recruiting |
| Age Group: |
8-21 |
|
Enrollment goal:
|
100 |
|
Description:
|
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. |
| Contact: |
Melissa Cadnapaphornchai, M.D. at 303-724-1690 or pkd.nurse@uchsc.edu
Linda Perkins at 303-724-1690 or pkd.nurse@uchsc.edu.
You may also call toll-free at 1-877-765-9297.
|
| Website: |
NIH Study Details
|
|
|
The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in ADPKD
|
Intervention:
|
Drug - High or low sodium diet |
|
Sponsor:
|
Holstebro Hospital, Denmark |
| Status: |
Recruiting |
| Age Group: |
18-65 |
|
Enrollment goal:
|
25 |
|
Description:
|
To examine the effect of high and low diets on kidney function and on hormones that affect the kidney. |
| Contact: |
Carolina Cannillo, M.D. at 1145099125428 or cacan@ringamt.dk |
| Website: |
NIH Study Details |
|
|
CCB Safety Study in Treatment of Hypertension in ADPKD
|
Intervention:
|
Drugs - Candesartan; Candesartan Cilnidipine; Candesartan non-calcium channel blocker (CCB) |
|
Sponsor:
|
Kyorin University, Japan |
|
Study Phase:
|
IV |
| Status: |
Recruiting |
| Age Group: |
20-60 |
|
Enrollment goal:
|
150 |
|
Description:
|
To evaluate the safety and efficacy of calcium channel blocker Candesartan in treatment of hypertension in ADPKD patients. |
| Contact: |
Eiji Higashihara, M.D. at 81-422-47-5511, ext. 5813 or ehigashi@kyorin-u.ac.jp |
| Website: |
NIH Study Details |
|
|
Study for the Second Line Treatment of Hypertension in Patients With ADPKD
|
Intervention:
|
Drug - Candesartan, Cilnidipine, Imidapril |
|
Sponsor:
|
The Ministry of Health, Labour & Welfare, Japan; Teikyo University |
|
Study Phase:
|
II |
| Status: |
Not yet Recruiting |
| Age Group: |
20-60 |
|
Enrollment goal:
|
160 |
|
Description:
|
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
|
| Contact: |
Shigeo Horie, MD at +81339642497shorie@med.teikyo-u.ac.jp
Satoru Muto, MD, PhD at +81339642497muto@med.teiku-u.ac.jp |
| Website: |
NIH Study Details
|
|
mTOR Inhibitor Clinical Trials
|
Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients with ADPKD
|
Intervention:
|
Drug - Everolimus |
|
Sponsor:
|
Novartis |
|
Study Phase:
|
III |
| Status: |
Recruiting |
| Age Group: |
18-65 |
|
Enrollment goal:
|
300 |
|
Description:
|
To evaluate the anti-proliferative drug Everolimus as a means to slow disease progression in PKD by measuring total kidney and cyst volumes and changes in renal function. |
| Contact: |
Novartis, Freiburg, Germany 41-61-324-1111 |
| Website: |
NIH Study Details |
|
|
Rapamycin as a Treatment for ADPKD: The Role of Biomarkers in Predicting a Response to Therapy
|
Intervention:
|
Drug - Rapamycin |
|
Sponsor:
|
Yale Center for Clinical Investigation |
|
Study Phase:
|
II & III |
| Status: |
Recruiting |
| Age Group: |
18-70 |
|
Enrollment goal:
|
45 |
|
Description:
|
To determine the safety & effectiveness of treatment with rapamycin for patients with ADPKD, patients will be observed for change in kidney (& cyst) size by following the patient’s through volumetric magnetic resonance imaging (MRI). To evaluate for change in biomarkers with treatment, blood and urine samples will be collected during the study. |
| Contact: |
Neera K. Dahl, MD, PhD at 203-785-4184 or neera.dahl@yale.edu |
| Website: |
NIH Study Details |
|
|
Sirolimus Treatment in Patients with ADPKD: Renal Efficacy and Safety
|
Intervention:
|
Drug - Sirolimus |
|
Sponsor:
|
Mario Negri Institute for Pharmacological Research |
|
Study Phase:
|
II |
| Status: |
Recruiting |
| Age Group: |
18-80 |
|
Enrollment goal:
|
16 |
|
Description:
|
To determine if the addition of sirolimus to conventional high blood pressure therapy can prevent a further increase in or can reduce total kidney and cyst volumes in ADPKD adults with normal and mild to moderate renal insufficiency. |
| Contact: |
Norberto Perico, MD at 0039 035-45351 or perico@marionegri.it |
| Website: |
NIH Study Details |
|
|
Sirolimus (Rapamune) for ADPKD
|
Intervention:
|
Drug - Rapamycin |
|
Sponsor:
|
The University of Zurich |
|
Study Phase:
|
III |
| Status: |
Active, enrollment complete |
| Age Group: |
18-40 |
|
Enrollment goal:
|
100 |
|
Description:
|
To investigate whether a low dose of sirolimus retards cyst growth and slows renal functional deterioration in patients with ADPKD. |
| Contact: |
Andreas Serra, MD at 41 44 255 33 84 or andreas.serra@usz.ch |
| Website: |
NIH Study Details |
|
|
Pilot Study of Rapamycin as Treatment for ADPKD
|
Intervention:
|
Drug - Rapamycin |
|
Sponsor:
|
The Cleveland Clinic |
|
Study Phase:
|
I & II |
| Status: |
Recruiting |
| Age Group: |
18-75 |
|
Enrollment goal:
|
30 |
|
Description:
|
To compare the effects of an anti-proliferative, anti-angiogenesis and tumor-progression-blocking agent on disease progression in ADPKD. Due to the intensive and frequent testing schedule, enrollment is limited to local patients only. |
| Contact: |
Susan Wirth at 216-444-0124 or wirths@ccf.org |
| Website: |
NIH Study Details |
|
Somatostatin Clinical Trials
|
Somatostatin in Polycystic Kidney: A Long-term Three Year Follow-up Study
|
Intervention:
|
Drug - Long-acting somatostatin |
|
Sponsor:
|
Mario Negri Institute for Pharmacological Research |
|
Study Phase:
|
III |
| Status: |
Recruiting |
| Age Group: |
18-75 |
|
Enrollment goal:
|
66 |
|
Description:
|
To compare the effects on disease progression of a three year treatment regimen using long-acting somatostatin or placebo in patients with ADPKD and normal renal function or mild to moderate renal insufficiency. |
| Contact: |
Norberto Perico, MD at 0039 035-45351 or perico@marionegri.it |
| Website: |
NIH Study Details |
|
|
Octreotide in Severe Polycystic Liver Disease
|
Intervention:
|
Drug - Octreotide (long-acting somatostatin) |
|
Sponsor:
|
Mayo Clinic; Novartis |
|
Study Phase:
|
II & III |
| Status: |
Recruiting |
| Age Group: |
18-80 |
|
Enrollment goal:
|
42 |
|
Description:
|
To evaluate the effect of Octreotide LAR on liver volumes of patients with severe polycystic liver disease who are not candidates for or decline surgical treatments such as liver cyst fenestration or liver transplantation. |
| Contact: |
Marie Hogan, M.D., Ph.D. at 507-538-9851 or Linda Page at 507-538-9851 |
| Website: |
NIH Study Details |
|
|
Lanreotide as Treatment of Polycystic Liver Disease
|
Intervention:
|
Lanreotide |
|
Sponsor:
|
Radboud University |
|
Study Phase:
|
II & III |
| Status: |
Completed |
| Age Group: |
18-88 |
|
Enrollment goal:
|
38 |
|
Description:
|
To assess the effectiveness of lanreotide in controlling total liver volume in patients with polycystic livers. |
| Contact: |
info@livercyst.org |
| Website: |
NIH Study Details |
|
Tolvaptan Clinical Trial
|
Tolvaptan Tempo 3 / 4 Trial
|
Intervention:
|
Drug - Tolvaptan |
|
Sponsors:
|
Otsuka Pharmaceutical Development & Commercialization, Inc.; Otsuka Pharmaceutical Co., Ltd. |
|
Study Phase:
|
III |
| Status: |
Active; enrollment complete |
| Age Group: |
18-50 |
|
Enrollment goal:
|
1,500 |
|
Description:
|
To evaluate the long-term effectiveness and safety of Tolvaptan by monitoring total kidney volume and cyst volumes by magnetic resonance imaging and measuring a composite of clinical markers in ADPKD patients. |
| Contact: |
Within North America: Kristin Cornwell at 866-712-5837 or kristin.cornwell@mayo.edu |
| Websites: |
NIH Study Details
|
|
Triptolide Clinical Trial
|
Randomized Clinical Trial of Triptolide Woldifii for ADPKD
|
Intervention:
|
Drugs - Tripterygium wilfordii, Emodin, Losartan |
|
Sponsor:
|
Nanjing University School of Medicine, China |
| Status: |
Recruiting |
| Age Group: |
15-70 |
|
Enrollment goal:
|
150 |
|
Description:
|
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. |
| Contact: |
Yao Xiaodan at +00862586030066 or yaoxiaodan@hotmail.com |
| Website: |
NIH Study Details
|
|
Water Therapy Clinical Trials
|
Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
|
Intervention:
|
Water Prescription |
|
Sponsor:
|
University of Kansas |
| Status: |
Completed |
| Age Group: |
18-50 |
|
Enrollment goal:
|
10 |
|
Description:
|
To formulate a water prescription for use in clinical trials to determine the effect of sustained diuresis on the progression of ADPKD. Enrollment is limited to local patients only. |
| Contact: |
Connie Wang, M.D. at 913-588-6074 or cwang@kumc.edu |
| Website: |
NIH Study Details
|
|
|
High Water Intake to Slow Progression of PKD
|
Intervention:
|
Water |
|
Sponsor:
|
New York University School of Medicine |
| Status: |
Recruiting |
| Age Group: |
18-65 |
|
Enrollment goal:
|
20 |
|
Description:
|
To evaluate the changes in urine composition in PKD patients versus healthy individuals with high water intake by monitoring urinary biomarkers. |
| Contact: |
Irina Barash, MD at 212-263-5851 or irina.barash@nyumc.org |
| Website: |
NIH Study Details
|
|
ARPKD Clinical Trials
|
Evaluation of ARPKD and Congenital Hepatic Fibrosis
|
Observational
|
|
|
Sponsor:
|
National Human Genome Project (NHGRI) |
| Status: |
Recruiting |
| Age Group: |
6 months – 80 years |
|
Enrollment goal:
|
200 |
|
Description:
|
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. |
| Contact: |
Patient Recruitment and Public Liaison Office at 1- 800-411 1222 or prpl@mail.cc.nih.gov |
| Website: |
NIH Study Details
|
|
|
The ARPKD Clinical and Genetic Resource
|
Observational
|
|
| Sponsors: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Status: |
Recruiting |
| Age Group: |
Up to 35 years |
|
Enrollment goal:
|
200 |
|
Description:
|
The Core has three primary objectives: To extend the observational study of ARPKD initiated by the North American ARPKD Database; to provide a mechanism for genetic evaluation of patients with both classic ARPKD and unusual phenotypes of recessive PKD; and to develop educational tools for physicians and patients regarding the natural history, cause, development and effects of the disease, genetic testing, and clinical trials applicable to ARPKD. |
| Contact: |
Lisa M. Guay-Woodford, M.D. - 205-934-7308 or lgw@uab.edu
Teresa Chacana, B.S.N. - 205-934-7649 or tchacana@uab.edu |
| Website: |
NIH Study Details
|
|
Transplant-Related Clinical Trials
|
Transplant Registry: Patients Who May Require Transplantation and Those Who Have Undergone Transplantation of Liver, Kidney and/or Pancreas
|
Observational
|
|
|
Sponsor:
|
Virginia Commonwealth University |
| Status: |
Recruiting |
| Enrollment goal: |
2,000 |
|
Description:
|
To make a systematic review of medical records of patients (with patient consent) in the Virginia commonwealth University Health System who have received a liver, kidney or pancreas or who may require one and to enter the data into a secure database. |
|
Contact:
|
Robert Fisher, M.D. - 804-828-2461
Cheryl Rodgers, BSN, RN - 804-828-2463 |
| Website: |
NIH Study Details
|
|
|
CMV Glycoprotein B Vaccine in Allograft Recipients
|
Intervention:
|
Biological -- CMV gB vaccine, placebo |
|
Sponsor:
|
National Institute of Allergy and Infectious Diseases (NIAID) |
| Status: |
Recruiting |
| Age Group: |
18 and older |
|
Enrollment goal:
|
140 |
|
Description:
|
Post-transplant use of immune-suppressive drugs to prevent rejection of the transplanted organ suppresses the recipient’s immune system. This can result in infection by Cytomegalovirus (CMV), a common infectious agent. The purpose of this study is to determine if a CMV vaccine administered to patients awaiting transplant can produce immunity to CMV in the post-transplant period. |
| Contact: |
Paul Griffiths at +44 20 7830 2997 |
| Website: |
NIH Study Details
|
|
|
Polycystic Liver Disease in Kidney Transplant
|
Intervention:
|
Drug -- Tacrolimus, Sirolimus, Mycophenolate Mofetil + Prednisone |
|
Sponsor:
|
Mayo Clinic |
| Status: |
Recruiting |
| Age Group: |
18 and older |
|
Enrollment goal:
|
68 |
|
Description:
|
The purpose of this study is to see if one kind of anti-rejection drug has better effects for the patient's polycystic liver disease than another type. Tacrolimus and Sirolimus are the two anti-rejection drugs that will be compared for this study. |
| Contact: |
Qi Qian, MD at 507-284-2511 or qian.qi@mayo.edu
Stacy Anderson at 507-538-9522 or anderson.stacy@mayo.edu |
| Website: |
NIH Study Details
|
|
Pain Clinical Trial
|
ADPKD Pain Study
|
Intervention:
|
Procedure - Videothracoscopic Splanchnicectomy (VSPL) |
|
Sponsor:
|
Mayo Clinic |
|
Study Phase:
|
II |
| Status: |
Recruiting |
| Age Group: |
18 and older |
|
Enrollment goal:
|
20 |
|
Description:
|
To evaluate the effectiveness of VSLP procedure for pain management in patients with ADPKD |
| Contact: |
Beverly Tietje at 507-255-0401 or Tietje.beverly@mayo.edu |
| Website: |
NIH Study Details
|
|
|
|