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NCT01885559 · ClinicalTrials.gov registry record · Phase 3
HALT Progression of Polycystic Kidney Disease Study B
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 486
- Enrollment target
NCT01885559: Completed Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01885559 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 486 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01885559, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 486 participants
- Enrollment target
Study 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 simultaneous 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 B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
Interventions
- DRUG Placebo
- DRUG Telmisartan
- DRUG Lisinopril
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 486 participants |
| Start Date | 2006-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01885559 record still lists
NCT01885559 is an interventional study that assigns participants to a tested intervention. The registered 486 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01885559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01885559 about?
NCT01885559 is a clinical study titled "HALT Progression of Polycystic Kidney Disease Study B". 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 simultaneous multicenter randomized clinical trials targeting different level...
What is the current status of trial NCT01885559?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 486 participants. The study started on 2006-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01885559?
The interventions under investigation include: Placebo (DRUG), Telmisartan (DRUG), Lisinopril (DRUG).
Who is sponsoring clinical trial NCT01885559?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01885559's enrollment target sits among peer trials
486 789th of 2000 higher than 1,211 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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