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NCT00283686 · ClinicalTrials.gov registry record · Phase 3

HALT Progression of Polycystic Kidney Disease Study A

A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
Phase 3
Development phase
558
Enrollment target

NCT00283686: Completed Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT00283686 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 558 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00283686, 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
558 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 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.

Primary Outcome

Annual percentage change in total kidney volume as assessed by abdominal magnetic resonance imaging (MRI) at baseline, 2 years, 4 years, and 5 years follow-up.

Interventions

  • DRUG Placebo
  • DRUG Telmisartan
  • DRUG Lisinopril
  • OTHER Standard Blood Pressure Control
  • OTHER Low Blood Pressure Control

Trial Details

FieldValue
Enrollment Target 558 participants
Start Date 2006-01
Est. Completion 2014-06
Phase Phase 3

What the finished NCT00283686 record still lists

NCT00283686 is an interventional study that assigns participants to a tested intervention. The registered 558 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 (28% lower).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT00283686 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00283686 about?

NCT00283686 is a clinical study titled "HALT Progression of Polycystic Kidney Disease Study A". 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 f...

What is the current status of trial NCT00283686?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 558 participants. The study started on 2006-01. Estimated completion is 2014-06.

What interventions are being tested in trial NCT00283686?

The interventions under investigation include: Placebo (DRUG), Telmisartan (DRUG), Lisinopril (DRUG), Standard Blood Pressure Control (OTHER), Low Blood Pressure Control (OTHER).

Who is sponsoring clinical trial NCT00283686?

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.

How this trial's enrollment target compares

Where NCT00283686's enrollment target sits among peer trials

558 673rd of 2000 higher than 1,327 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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Source: ClinicalTrials.gov NCT00283686, the US trial registry maintained by the National Library of Medicine. NCT00283686 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.