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PKD Clinical Trials NOTE: The clinical trial descriptions below are for informational purposes only. Individuals with PKD should discuss with their health care providers whether or not participation in a clinical trial is appropriate and advisable. You or your health care provider can also discuss this with the Principal Investigator of the study in order to determine if you are eligible and if it is advisable for you to enroll. Understanding Clinical Trials Choosing to participate in a clinical trial is an important personal decision. To help make the decision, this website provides detailed information about clinical trials in general. Individuals with PKD should discuss with their health care providers whether or not participation in a clinical trial is appropriate and advisable for them. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials. In order to participate in one of the clinical trials listed below, an individual must have a diagnosis of PKD. Making the decision to seek an official diagnosis, which then becomes part of an individual's medical records, can be difficult. For more information about making a clinical diagnosis of PKD, please click here. Definitions
Interventional Study: Drugs prescribed and their effect on PKD disease progression monitored
Observational Study: No drugs given. PKD disease progression and/or other parameters monitored. Clinical Trials for ADPKD Patients HALT PKD Progression of PKD (HALT PKD) Intervention: Drugs -- lisonopril, telmisartan
Sponsors: NIDDK, Boehringer-Ingelheim Pharmaceuticals, Merck, PKD Foundation
Status: Recruiting
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.
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Contact: Robin Woltman at 314-362-1318 or robinw@wubios.wustl.edu
Gigi Flynn at 314-362-3737, or gigi@wubios.wustl.edu Heart Disease and PKD: DID YOU KNOW ... ? 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.
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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. 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.
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Contact: Norberto Perico, MD at 0039 035-45351 or perico@marionegri.it 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.
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Contact: Marie Hogan, M.D., Ph.D. at 507-538-9851 or Linda Page at 507-538-9851 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.
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Contact: info@livercyst.org 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.
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Contact: Novartis, Freiburg, Germany 41-61-324-1111 Rapamycin as a Treatment in 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 if the safety & effectiveness of treatment with rapamycin for patients with ADPKD, patients with 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.
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Contact: Neera K. Dahl, MD, PhD at 203-785-4184 or neera.dahl@yale.edu 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.
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Contact: Norberto Perico, MD at 0039 035-45351 or perico@marionegri.it 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.
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Contact: Andreas Serra, MD at 41 44 255 33 84 or andreas.serra@usz.ch 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.
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Contact: Susan Wirth at 216-444-0124 or wirths@ccf.org Randomized Clinical Trial of Triptolide Woldifii for ADPKD Intervention: Drugs – Tripterygium wilfordii, Emodin, Losartan
Sponsors: 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
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Contact: Yao Xiaodan at +00862586030066 or yaoxiaodan@hotmail.com ADPKD Pain Study Intervention: Procedure: Videothracoscopic Splanchnicectomy (VSPL)
Sponsors: 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
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Contact: Mark Manemann at 507-266-3088 or manemann.mark@mayo.edu Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Intervention: Water Prescription
Sponsor: University of Kansas University
Status: Recruiting 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.
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Contact: Connie Wang, M.D. at 913-588-6074 or cwang@kumc.edu High Water Intake to Slow Progression of PKD
Interventional: Water
Sponsors: 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 The Effect of High and Low Sodium Intake on Urinary Aquaportin-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.
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Contact: Carolina Cannillo, M.D. at 1145099125428 or cacan@ringamt.dk 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.
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Contact: Eiji Higashihara, M.D. at 81-422-47-5511, ext. 5813 or ehigashi@kyorin-u.ac.jp 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
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Contact: Shigeo Horie, MD at +81339642497shorie@med.teikyo-u.ac.jp or Satoru Muto, MD, PhD at +81339642497muto@med.teiku-u.ac.jp 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.
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Contact: Within North America: Kristin Cornwell at 866-712-5837 or kristin.cornwell@mayo.edu .
Outside North America: 800-712-58370 Clinical Trials for ARPKD patients 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.
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Contact: Patient Recruitment and Public Liaison Office at 1- 800-411 1222 or prpl@mail.cc.nih.gov 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.
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Contact: Lisa M. Guay-Woodford, M.D. at 205-934-7308 or lgw@uab.edu
Teresa Chacana, B.S.N. at 205-934-7649 or tchacana@uab.edu Transplant-related Studies 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: RecruitingEnrollment 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.
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Contact: Robert Fisher, M.D. at 804-828-2461
Cheryl Rodgers, BSN, RN 804-828-2463 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.
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Contact: Paul Griffiths at +44 20 7830 2997 Donate to support PKD research.
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