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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Boehringer Ingelheim Pharmaceuticals Merck Polycystic Kidney Disease Foundation |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00283686 |
The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study A will be followed for a total of four years, while those enrolled in Study B will be followed for four-to-six years, with the average length of follow-up being five years.
The two concurrent randomized clinical trials differ by eligibility criteria, interventions and outcomes to be studied.
Condition | Intervention | Phase |
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Kidney, Polycystic |
Drug: Lisinopril and Placebo Drug: Lisinopril and Telmisartan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Polycystic Kidney Disease-Treatment Network |
Estimated Enrollment: | 1018 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Study A, Arm 1: Active Comparator
ACE-I + ARB and standard blood pressure control of 120-130/70-80 mm Hg
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Drug: Lisinopril and Telmisartan
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg.
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Study A, Arm 2: Active Comparator
ACE-I + ARB and low blood pressure control of 95-110/60-75 mm Hg
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Drug: Lisinopril and Telmisartan
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg.
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Study A, Arm 3: Placebo Comparator
ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg
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Drug: Lisinopril and Placebo
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg.
|
Study A, Arm 4: Placebo Comparator
ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg
|
Drug: Lisinopril and Placebo
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg.
|
Study B, Arm 1: Active Comparator
ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg
|
Drug: Lisinopril and Telmisartan
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
|
Study B, Arm 2: Placebo Comparator
ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg
|
Drug: Lisinopril and Placebo
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
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To study the efficacy of ACE-I/ARB combination therapy as compared to ACE-I monotherapy and usual vs. low blood pressure targets on the percent change in kidney volume in participants with preserved renal function (GFR >60 mL/min/1.73m2)and high-normal blood pressure or hypertension (>130/80 mm Hg).
In ADPKD individuals with hypertension or high-normal blood pressure and relatively preserved renal function (GFR >60 mL/min/1.73 m2), multi-level blockade of the RAAS using ACE-I/ARB combination therapy will delay progression of cystic disease as compared to ACE-I monotherapy, and a low blood pressure goal will delay progression as compared with standard control.
To study the effects of ACE-I/ARB combination therapy as compared to ACE-I monotherapy in the setting of standard blood pressure control (110-130/80 mm Hg) on the time to a 50% reduction of baseline eGFR, ESRD or death, in hypertensive individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73m2).
In hypertensive ADPKD individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73 m2), intensive blockade of the RAAS using combination ACE-I/ARB therapy will slow the decline in kidney function over ACE-I monotherapy, independent of standard blood pressure control (110-130/80 mm Hg).
Ages Eligible for Study: | 15 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robin Woltman, B.S. | 314-362-1318 | robinw@wubios.wustl.edu |
United States, Colorado | |
University of Colorado Health Sciences Center | Recruiting |
Denver (Aurora), Colorado, United States, 800045 | |
Contact: Judy McCarty 877-765-9297 halt.pkd@uchsc.edu | |
Contact: Pamela Morgan, R.N. 877-765-9297 halt.pkd@uchsc.edu | |
Principal Investigator: Robert Schrier, M.D. | |
Sub-Investigator: Elwaleed Elhassan, M.D. | |
United States, Georgia | |
Emory University School of Medicine | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Stacie Hitchcock 404-712-1235 shitch2@emory.edu | |
Contact: Diane Watkins (404) 712-1354 dpwatki@emory.edu | |
Principal Investigator: Arlene Chapman, M.D. | |
Sub-Investigator: Frederic Rahbari-Oskoui, M.D. | |
United States, Kansas | |
University of Kansas Medical Center | Recruiting |
Kansas City, Kansas, United States, 66160 | |
Contact: Pam Lanza, RN 913-588-7609 planza@kumc.edu | |
Contact: Darlene Baker, RN 913-588-7609 dbaker@kumc.edu | |
Principal Investigator: Franz Winklhofer, M.D. | |
Sub-Investigator: Jared Grantham, M.D. | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Bonnie Maxwell, R.N. 866-650-1815 bmaxwel1@bidmc.harvard.edu | |
Principal Investigator: Theodore Steinman, M.D. | |
Sub-Investigator: Joshua Tarkan, M.D. | |
Tufts University-New England Medical Center | Recruiting |
Boston, Massachusetts, United States, 02111 | |
Contact: Peachy Simon, BSN, RN, CNN 866-846-2735 psimon@tufts-nemc.org | |
Contact: Julie Driggs, RN (866) 846-2735 jdriggs@tufts-nemc.org | |
Principal Investigator: Ronald Perrone, M.D. | |
Sub-Investigator: Dana Miskulin, M.D. | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Troy Ofstie 888-630-2616 troy.ofstie@mayo.edu | |
Contact: Otto Kris, RNC 888-630-2616 otto.kristine@mayo.edu | |
Principal Investigator: Vicente Torres, M.D. | |
Sub-Investigator: Marie Hogan, M.D. | |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Rita Spirko, R.N. 800-223-2273 ext 44680 spirkor@ccf.org | |
Principal Investigator: William Braun, M.D. | |
Sub-Investigator: Brian Stephany, M.D. |
Study Chair: | Robert Schrier, M.D. | University of Colorado at Denver and Health Sciences Center |
Principal Investigator: | Arlene Chapman, M.D. | Emory University |
Principal Investigator: | J. Philip Miller, A.B. | Washington University School of Medicine |
Principal Investigator: | Ronald Perrone, M.D. | Tufts University-New England Medical Center |
Principal Investigator: | Vicente Torres, M.D. | Mayo Clinic |
Study Director: | Catherine Meyers, M.D. | National Institute of Diabetes & Digestive & Kidney Diseases |
Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases ( Dr. Catherine Meyers, Director, Inflammatory Renal Diseases Program ) |
Study ID Numbers: | DK62401-PKD-TN |
Study First Received: | January 26, 2006 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00283686 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United States: Federal Government |
polycystic kidney disease polycystic kidney disease adpkd halt pkd |
blood pressure bp hypertension renal renin-angiotensin-aldosterone-system RAAS |
Kidney Diseases, Cystic Lisinopril Polycystic Kidney Diseases Disease Progression Cardiovascular Agents Angiotensin II Antihypertensive Agents Protease Inhibitors |
Angiotensin II Type 1 Receptor Blockers Urologic Diseases Angiotensin-Converting Enzyme Inhibitors Kidney Diseases Telmisartan Hypertension Autosomal Dominant Polycystic Kidney Disease |
Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Physiological Effects of Drugs Kidney Diseases, Cystic Lisinopril Polycystic Kidney Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents |
Protective Agents Pharmacologic Actions Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Urologic Diseases Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Kidney Diseases Telmisartan |