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NCT00270153 · ClinicalTrials.gov registry record · Phase 1
The Use of ACE Inhibitors in the Early Renal Post-transplant Period
A Phase 1 study of Renal Transplant, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT00270153 is a Phase 1 study of Renal Transplant that has completed, run by Montefiore Medical Center. The registered enrollment target is 110 participants, above the 30-participant average among 5 other Renal Transplant trials with a reported enrollment target (267% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00270153, a Phase 1 study of Renal Transplant, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
Chronic allograft nephropathy (CAN) is the leading cause of longterm renal transplant loss. Angiotensin-II may play a role in the development and progression of CAN. Angiotensin converting enzyme inhibitors (ACEI) comprise a drug class that inhibit the effects of angiotensin-II. However these drugs have been reported to cause elevated potassium and creatinine levels in some renal transplant patients. Yet, there are now several retrospective reports of long term benefits of improved renal function and graft survival in renal transplant recipients. There have been no reports of prospective randomized controlled trials of ACEI in renal transplant patients in the early post transplant period. The purpose of the present study is to assess the safety of enalapril, a drug in the ACEI class, when started 1-3 month post transplant. This is a double-blinded, randomized control trial of enalapril vs. placebo in new renal transplant patients with serum creatinine values no higher than 2.5mg/dl and normal serum potassium levels. The study drug will be administered for 6 months. Patients will be monitored in the renal transplant clinic every 1-4 weeks according to routine protocol. Clinical end-points will be occurence of potassium \>5.9mEQ/L or sustained increase in serum creatinine \>30% from baseline.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG enalapril
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00270153
The ClinicalTrials.gov registry entry for NCT00270153 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 30-participant average among 5 other Renal Transplant trials with a reported enrollment target (267% higher). The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Renal Transplant appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00270153 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00270153 about?
NCT00270153 is a clinical study titled "The Use of ACE Inhibitors in the Early Renal Post-transplant Period". Chronic allograft nephropathy (CAN) is the leading cause of longterm renal transplant loss. Angiotensin-II may play a role in the development and progression of CAN. Angiotensin converting enzyme inhibitors (ACEI) comprise a drug class that inhibit the effects of angiotensin-II. However these drugs ...
What is the current status of trial NCT00270153?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2004-09. Estimated completion is 2009-12.
What conditions does trial NCT00270153 study?
This clinical trial studies the following conditions: Renal Transplant.
What interventions are being tested in trial NCT00270153?
The interventions under investigation include: Placebo (DRUG), enalapril (DRUG).
Who is sponsoring clinical trial NCT00270153?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00270153 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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