SPECIAL NOTICE
A -- Multicenter clinical trials: study of angiotensin converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) therapy in hypertensives with Polycystic Kidney Disease (PKD)
- Notice Date
- 5/7/2003
- Notice Type
- Special Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- Reference-Number-DK-02-0152
- Response Due
- 6/9/2003
- Archive Date
- 6/24/2003
- Point of Contact
- Rochelle Blaustein J.D., Director, Technology Transfer and Development, Phone 301-451-3636, Fax 301-401-7461, - Linda Schilling, Technology Development Specialist, Phone 301-451-3638, Fax 301-402-7461,
- E-Mail Address
-
rochelleb@intra.niddk.nih.gov, lindas@intra.niddk.nih.gov
- Description
- Multicenter randomized clinical trials studying the impact of combined angiotensin converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) therapy on kidney disease progression in hypertensive patients with Polycystic Kidney Disease (PKD): The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) of the Public Health Service of the Department of Health and Human Services seeks collaborations with Industry to provide blinded (ACE inhibitor, ARB, and long-acting metoprololol) and unblinded (hydrochlorothiazide, furosemide, clonidine, and a non-dihydropyridine calcium channel blocker) anti-hypertensive medications to study their impact on kidney disease progression in the setting of PKD. The study group will perform two prospective, randomized, placebo-controlled multicenter clinical trials of combined ACE inhibitor and ARB therapy. In one trial, 560 hypertensive patients at an early stage of PKD will be recruited and the trial will compare combined ACE inhibitor and ARB therapy to beta-blocker, as the primary blinded intervention. Two different levels of blood pressure control will be studied. In the second trial, 700 patients with more advanced PKD will be recruited and the trial will compare combined ACE inhibitor and ARB therapy to ACE inhibitor, as the primary blinded intervention. Enrollment for both trials will occur at four participating clinical centers. The trials will have a two-year recruitment phase, and patients will have an average follow-up of four years. Central data collection and analysis will occur at the NIDDK-funded Data Coordinating Center at Washington University, St. Louis, MO. Although substantial experimental and clinical data implicate the renin-angiotensin-aldosterone system (RAAS) in the pathogenesis of hypertension in PKD, in the progression of structural changes such as renal cyst growth and renal interstitial fibrosis, and in the development of left ventricular hypertrophy, clinical studies to date have not addressed whether complete blockade of the RAAS alters the clinical course of PKD. This effort therefore represents the first large NIH-sponsored interventional trials of PKD, which will allow prospective evaluation and follow-up of a large cohort of PKD patients, and will determine the impact of intensive blockade of the RAAS and level of blood pressure control in patients with early and more advanced PKD. CAPABILITY STATEMENTS: The Selection Committee will utilize the information provided in the ?Collaborator Capability Statements? to help in the selections. It is the intention of the NIDDK that qualified applicants will have the opportunity to provide information to the Selection Committee through their Capability Statements. The Capability Statement may not exceed 10 pages and should address the following selection criteria: (1) willingness and ability to provide blinded and unblinded anti-hypertension medications; (2) willingness and ability to provide repackaging and distribution of blinded medications; (3) timeline for providing medications. SUBMISSION DATE: A Collaborator Capability Statement must be submitted by June 9, 2003. CONTACT INFORMATION: Collaborator Capability Statements should be sent to: Rochelle S. Blaustein, J.D., Office of Technology Transfer and Development, National Institute of Diabetes and Digestive and Kidney Diseases, 12 South Dr, MSC 5632, Bethesda, MD 20892-5632; Telephone: (301) 451-3636; FAX: (301) 402-7461; Email: RochelleB@Intra.NIDDK.NIH.gov. For Scientific Inquiries contact Catherine M. Meyers, M.D.; Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases; Two Democracy Plaza, Room 641; 6707 Democracy Blvd.; Bethesda, MD 20892-5458; Telephone: (301) 594-7717; FAX: (301) 480-3510; Email: MeyersC@extra.niddk.nih.gov
- Record
- SN00319375-W 20030509/030507213251 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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