Status:
COMPLETED
HALT Progression of Polycystic Kidney Disease Study A
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
Boehringer Ingelheim
Merck Sharp & Dohme LLC
Conditions:
Kidney, Polycystic
Eligibility:
All Genders
15-64 years
Phase:
PHASE3
Brief Summary
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) w...
Detailed Description
\* Specific Aims of Study A To study the efficacy of angiotensin-converting-enzyme inhibitor (ACE-I) and angiotensin-receptor blockade (ARB) combination therapy as compared to ACE-I monotherapy and u...
Eligibility Criteria
Inclusion
- Diagnosis of ADPKD.
- Age 15-49 (Study A); Age 18-64 (Study B).
- GFR \>60 mL/min/1.73 m2 (Study A); GFR 25-60 mL/min/1.73 m2 (Study B).
- BP ≥130/80 or receiving treatment for hypertension.
- Informed Consent.
Exclusion
- Pregnant/intention to become pregnant in 4-6 yrs.
- Documented renal vascular disease.
- Spot urine albumin-to-creatinine ratio of \>0.5 (Study A) or ≥1.0 (Study B) and/or findings suggestive of kidney disease other than ADPKD.
- Diabetes requiring insulin or oral hypoglycemic agents / fasting serum glucose of \>126 mg/dl / random non-fasting glucose of \>200 mg/dl.
- Serum potassium \>5.5 milliequivalent per liter (mEq/L) for participants currently on ACE-I or ARB; \>5.0 mEq/L for participants not currently on ACE-I or ARB.
- History of angioneurotic edema or other absolute contraindication for ACE-I or ARB. Intolerable cough associated with ACE-I is defined as a cough developing within six months of initiation of ACE-I in the absence of other causes and resolving upon discontinuation of the ACE-I.
- Indication (other than hypertension) for β-blocker or calcium channel blocker therapy (e.g. angina, past myocardial infarction, arrhythmia), unless approved by the site principal investigator. (PI may choose to accept an individual who is on only a small dose of one of these agents and would otherwise be eligible.)
- Systemic illness necessitating nonsteroidal antiinflammatory drugs (NSAIDs), immunosuppressant or immunomodulatory medications.
- Systemic illness with renal involvement.
- Hospitalized for acute illness in past 2 months.
- Life expectancy \<2 years.
- History of non-compliance.
- Unclipped cerebral aneurysm \>7mm diameter.
- Creatine supplements within 3 months of screening visit.
- Congenital absence of a kidney (also total nephrectomy for Study B).
- Known allergy to sorbitol or sodium polystyrene sulfonate.
- Exclusions specific to magnetic resonance imaging (Study A).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT00283686
Start Date
January 1 2006
End Date
June 1 2014
Last Update
April 21 2020
Active Locations (7)
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1
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 800045
2
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
4
Tufts University-New England Medical Center
Boston, Massachusetts, United States, 02111