Angiotensin Converting Enzyme (ACE) inhibition for the preservation of renal function and patient survival in kidney transplantatio

Not Applicable

Completed

• Conditions: Chronic kidney disease in renal transplant patients; Urological and Genital Diseases; Chronic kidney disease

• Registration Number: ISRCTN78129473
• Lead Sponsor: Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-13
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 528

Inclusion Criteria

Current inclusion criteria as of 16/07/2008:
Patients, either sex, who underwent the kidney transplantation and who:
1. Have an estimated glomerular filtration rate greater than or equal to 20 ml/min/1.73 m^2 using the Modification of Diet in Renal Disease study (MDRD) equation which has been validated in renal transplant patients
2. Have proteinuria = 0.2 grams/day
3. Are at least three months post-transplantation
4. Have signed informed consent

Previous inclusion criteria:
Patients, either sex, who underwent the kidney transplantation and who:
1. Have an estimated glomerular filtration rate between 20 and 55 ml/min using the Modification of Diet in Renal Disease study (MDRD) equation which has been validated in renal transplant patients
2. Have proteinuria = 0.2 grams/day
3. Are at least six months post-transplantation
4. Have signed informed consent

Exclusion Criteria

1. Unable to provide informed consent
2. Less than 18 years old
3. Pregnant (ramipril contraindicated)
4. Angioedema from an ACE inhibitor or angiotensin receptor blocker or other known reaction to an ACE inhibitor (such as rash, neutropenia or cough)
5. Serum potassium greater than 5.5 mmol/l on two or more occasions in the preceding three months for those not on an ACE inhibitor or angiotensin receptor blocker
6. Serum potassium greater than 5.9 mmol/l on two or more occasions in the preceding three months for those on an ACE inhibitor or angiotensin receptor blocker
7. Left ventricular dysfunction that requires an ACE inhibitor or an angiotensin receptor blocker
8. Other severe co-morbid conditions (e.g. malignancy, disabling stroke) with life expectancy less than three months
9. New immunosuppressive agent was started or previous immunosuppressant stopped in the three months prior to study entry or plan to switch immunosuppressive agents within next three months
10. Had an acute coronary syndrome, stroke or transient ischaemic attack in the three months prior to study entry
11. Were previously enrolled in this study
12. Currently enrolled in another interventional trial
13. Currently on an ACE-inhibitor or an angiotensin receptor blocker and patient or physician unwilling to stop medication
14. Had an acute rejection episode in the three months prior to study entry
15. Currently on four or more blood pressure pills and have an average blood pressure over three visits greater than 150/100

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. A composite measure incorporating the following clinically important endpoints:<br>1.1. Doubling of serum creatinine<br>1.2. End-stage renal disease or death<br>2. Time points of measurement:<br>2.1. Doubling of serum creatinine will be confirmed by two consecutive tests at least four weeks apart in a central laboratory. The base creatinine for the primary outcome will be the creatinine performed at the time of randomisation.<br>2.2. End-stage renal disease will be defined as the date the patient undergoes repeat kidney transplantation or starts dialysis<br>2.3. Death defined as the date the patient dies