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

NCT00270153 | Completed Phase 1 FDA Drug

• 1 other identifier: 03-12-311
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplant

Keywords

renal transplant, ACE inhibitor

Outcome Measures

Primary Outcomes (3)

• Changes in serum creatinine levels assessed at 6 months

  Creatinine is a waste product that comes from the normal wear and tear on muscles of the body. It is excreted through the kidneys. High serum creatinine levels in the blood indicate that the kidneys aren't functioning properly. Increase in serum creatinine of 30% would be a safety concern and requires clinical management.

  Baseline and 6 months

• Changes in potassium levels assessed at 6 months

  Potassium is a chemical that is critical to the function of nerve and muscle cells, including those in your heart. Potassium levels must be kept within a very narrow concentration range. High Potassium levels are a sign of worsening kidney function. An occurence of serum potassium greater than 5.9 mEq/L is a safety concern and requires clinical management.

  Baseline and 6 months

• Decrease in estimated glomerular filtration rate (eGFR) assessed at 6 months

  eGFR is a number based on your blood test for creatinine, a waste product in your blood.It tells how well your kidneys are working. A normal eGFR is 60 or more. A 25 percent decrease in eGFR indicates that the kidneys may not be working well. This is a safety concern and requires clinical management.

  Baseline and 6 months.

Secondary Outcomes (4)

• Cough due to drug intolerance assessed at 6 months

  Baseline and 6 months

• abdominal pain due to drug intolerance assessed at 6 months

  Baseline and 6 months

• Erythrocytosis assessed at 6 months

  Baseline and 6 months

• Leukopenia assessed at 6 months

  Baseline and 6 months

Study Arms (2)

enalapril

PLACEBO COMPARATOR

Drug: enalapril

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

enalapril DRUG

5mg enalapril daily for 6 months

enalapril

Placebo DRUG

5mg enalapril-matching placebo daily for 6 months

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

Related Publications (1)

• 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.

  PMID: 39082471 DERIVED

MeSH Terms

Interventions

Enalapril

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Maria Coco, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2005
• First Posted: December 26, 2005
• Study Start: September 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

US (1)