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The Use of ACE Inhibitors in the Early Renal Post-transplant Period

This study has been completed.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00270153
First received: December 23, 2005
Last updated: September 15, 2011
Last verified: November 2009

December 23, 2005
September 15, 2011
September 2004
December 2009   (final data collection date for primary outcome measure)
changes in serum creatinine and potassium [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
changes in serum creatinine and potassium
Complete list of historical versions of study NCT00270153 on ClinicalTrials.gov Archive Site
patient death, allograft loss [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
patient death, allograft loss
Not Provided
Not Provided
 
The Use of ACE Inhibitors in the Early Renal Post-transplant Period
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 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 >50% from baseline.

All new renal transplant recipients with functioning allografts and serum creatinine less than 2.6 mg/dl within the first 3 month post transplant would be eligible for this study of the safety of enalapril 5 mg vs placebo. Patients with serum potassium persistently over 5.5 mEQ/L would be excluded. This is a double-blinded randomized control study. End-points of the study are a persistent rise in serum creatinine of >50% from baseline not otherwise explained by clinical evaluation, and persistent serum potassium >5.9mEQ/L. Study duration is 6 month. At the end of the study patients will be continued on ACEI if clinically stable

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Renal Transplant Patients
Drug: enalapril
5mg enalapril vs placebo pill po daily for 6 months
Placebo Comparator: enalapril
Intervention: Drug: enalapril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:new adult renal transplant recipients with good renal function defined as serum creatinine less than 2.6 mg/dl, normal serum potassium levels, and no contraindication to ACE inhibitor use.

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Exclusion Criteria: renal transplant patients with persistent serum creatinine levels over 2.5 mg/dl, hyperkalemia with serum potassium levels over 5.5 mEQ/dl, history of allergic reaction to ACE inhibitors or angiotensin receptor blockers, pregnancy

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Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00270153
MMCIRBPN03-12-311
No
Maria Coco, MD, Montefiore Medical Center
Montefiore Medical Center
Not Provided
Principal Investigator: Maria Coco, MD Montefiore Medical Center
Montefiore Medical Center
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP