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

Brief 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 >50% from baseline.

Condition or disease Intervention/treatment Phase
Renal Transplant Patients Drug: enalapril Not Applicable

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of ACE Inhibitors in the Early Renal Post-transplant Period
Study Start Date : September 2004
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: enalapril Drug: enalapril
5mg enalapril vs placebo pill po daily for 6 months

Primary Outcome Measures :
  1. changes in serum creatinine and potassium [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. patient death, allograft loss [ Time Frame: 6 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00270153

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
Sponsors and Collaborators
Montefiore Medical Center
Principal Investigator: Maria Coco, MD Montefiore Medical Center

Responsible Party: Maria Coco, MD, Montefiore Medical Center Identifier: NCT00270153     History of Changes
Other Study ID Numbers: MMCIRBPN03-12-311
First Posted: December 26, 2005    Key Record Dates
Last Update Posted: September 19, 2011
Last Verified: November 2009

Keywords provided by Montefiore Medical Center:
renal transplant, ACE inhibitor

Additional relevant MeSH terms:
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents