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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00555217
The ClinicalTrials.gov registry entry for NCT00555217 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,448 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which lisinopril is the first listed.
NCT00555217 reports 0 study locations.
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.
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