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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00270153
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : September 19, 2011
Information provided by:
Montefiore Medical Center

December 23, 2005
December 26, 2005
September 19, 2011
September 2004
December 2009   (Final data collection date for primary outcome measure)
changes in serum creatinine and potassium [ Time Frame: 6 months ]
changes in serum creatinine and potassium
Complete list of historical versions of study NCT00270153 on Archive Site
patient death, allograft loss [ Time Frame: 6 month ]
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
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Identifier (NCT Number) in Medline.
Same as current
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.

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

Sexes Eligible for Study: All
21 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
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