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

NCT ID: NCT00270153

Last Updated: 2019-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2009-12-31

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 >30% from baseline.

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 >30% 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

Conditions

Renal Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

enalapril

Group Type: PLACEBO_COMPARATOR

enalapril

Intervention Type: DRUG

5mg enalapril daily for 6 months

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

5mg enalapril-matching placebo daily for 6 months

Interventions

enalapril

5mg enalapril daily for 6 months

Intervention Type: DRUG

Placebo

5mg enalapril-matching placebo daily for 6 months

Intervention Type: DRUG

Eligibility 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,
• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Coco, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.

Reference Type: DERIVED

PMID: 39082471 (View on PubMed)

Other Identifiers

03-12-311

Identifier Type: -

Identifier Source: org_study_id