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
  Purpose

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 Intervention
Renal Transplant Patients
Drug: enalapril

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of ACE Inhibitors in the Early Renal Post-transplant Period

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • changes in serum creatinine and potassium [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • patient death, allograft loss [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: September 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: enalapril Drug: enalapril
5mg enalapril vs placebo pill po daily for 6 months

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

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270153

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

No publications provided

Responsible Party: Maria Coco, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00270153     History of Changes
Other Study ID Numbers: MMCIRBPN03-12-311
Study First Received: December 23, 2005
Last Updated: September 15, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Angiotensin-Converting Enzyme Inhibitors
Enalapril
Enalaprilat
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014