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NCT00555217 · ClinicalTrials.gov registry record · Phase 3
VA NEPHRON-D: Diabetes iN Nephropathy Study
A Phase 3 study, sponsored by US Department of Veterans Affairs.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,448
- Enrollment target
NCT00555217: Clinical Trial Phase 3 study, sponsored by US Department of Veterans Affairs.
NCT00555217 is a Phase 3 study that was terminated before completion, run by US Department of Veterans Affairs. The registered enrollment target is 1,448 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00555217, a Phase 3 study, was terminated before completion, sponsored by US Department of Veterans Affairs.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,448 participants
- Enrollment target
Study Summary
Diabetes is the leading cause of end-stage renal disease (ESRD) in the United States. The overall rate of ESRD secondary to diabetes has risen 68% since 1992. Medications that block the renin angiotensin system have been shown to decrease the progression of diabetic nephropathy. The use of an angiotensin receptor blocker (ARB) has been shown to decrease the risk of progression of kidney disease in two studies of individuals with Type 2 diabetes and proteinuria. Despite the use of an ARB, the incidence of renal failure remained high in the treated group in both studies. The combination of an angiotensin converting enzyme inhibitor (ACEI) and ARB can lead to more complete blockade of the renin angiotensin system. In diabetic kidney disease, combination therapy has been shown to decrease proteinuria in short-term studies. Although there are encouraging results for improvement in proteinuria there are no data on progression of kidney disease for the use of combination of ACEI and ARB therapy in patients with diabetes. In addition, there could be an increased risk of serious hyperkalemia in individuals with diabetes who receive combination ACEI and ARB. The investigators therefore propose a randomized double blind multi-center clinical trial to assess the effect of combination of ACEI and ARB in patients with diabetes and proteinuria on progression of kidney disease.
Primary Outcome
Time to the first event of reduction in estimated GFR of 30ml/min/1.73m\*m in individuals w/a baseline estimated GFR \>= 60 ml/min/1.73m\*m, reduction in estimated GFR \>50% in individuals w/ baseline estimated GFR \<60ml/min/1.73m\*m; ESRD or death.
Interventions
- DRUG lisinopril
- DRUG losartan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,448 participants |
| Start Date | 2008-07 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
Why NCT00555217 stopped before completion
NCT00555217 is an interventional study that assigns participants to a tested intervention. Its 1,448 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 2 interventions - of which lisinopril is the first listed.
NCT00555217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00555217 about?
NCT00555217 is a clinical study titled "VA NEPHRON-D: Diabetes iN Nephropathy Study". Diabetes is the leading cause of end-stage renal disease (ESRD) in the United States. The overall rate of ESRD secondary to diabetes has risen 68% since 1992. Medications that block the renin angiotensin system have been shown to decrease the progression of diabetic nephropathy. The use of an angiot...
What is the current status of trial NCT00555217?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,448 participants. The study started on 2008-07. Estimated completion is 2014-10.
What interventions are being tested in trial NCT00555217?
The interventions under investigation include: lisinopril (DRUG), losartan (DRUG).
Who is sponsoring clinical trial NCT00555217?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00555217's enrollment target sits among peer trials
1,448 167th of 2000 higher than 1,834 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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