Phase 3
N=558
HALT Progression of Polycystic Kidney Disease Study A
Kidney, Polycystic
Bottom Line
View on ClinicalTrials.gov: NCT00283686 ↗Enrolled (actual)
558
Serious AEs
26.5%
Results posted
Feb 2015
Primary outcome: Primary: Study A: Percent Annual Change in Total Kidney Volume — 6.0; 6.2; 5.6; 6.6 percentage of Total Kidney Volume — p=0.52
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lisinopril (Drug); Telmisartan (Drug); Placebo (Drug); Standard Blood Pressure Control (Other); Low Blood Pressure Control (Other)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study A: Percent Annual Change in Total Kidney Volume |
6.0; 6.2; 5.6; 6.6 | 0.52 |
| SECONDARY Kidney Function (eGFR) |
-3.0; -2.9; -2.9; -3.0 | 0.52 |
| SECONDARY Albuminuria |
-1.1; -0.4; -3.8; 2.4 | 0.57 |
| SECONDARY Aldosterone |
-8.5; -7.3; -8.5; -7.3 | 0.18 |
| SECONDARY Left Ventricular Mass Index |
-0.91; -0.83; -1.17; -0.57 | 0.58 |
| SECONDARY Renal Blood Flow |
-6.6; -9.5; -7.6; -8.5 | 0.29 |
| SECONDARY All-Cause Hospitalizations |
85; 128; 93; 120 | 0.0228 sig |
| SECONDARY Quality of Life Physical Component Summary |
-0.24; -.23; -0.17; -0.30 | 0.87 |
| SECONDARY Quality of Life Mental Component Summary |
0.19; -0.06; -0.05; 0.18 | 0.0221 sig |
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) 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; NCT01885559). 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 at least 5 years, while those enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. The two concurrent randomized clinical trials differ by eligibility criteria, interventions and outcomes to be studied.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 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).
Data sourced from ClinicalTrials.gov (NCT00283686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.