Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01885559
The ClinicalTrials.gov registry entry for NCT01885559 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 486 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01885559 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.