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Clinical Trials/ISRCTN78129473
ISRCTN78129473
Completed
未知

Angiotensin Converting Enzyme (ACE) inhibition for the preservation of renal function and patient survival in kidney transplantation: a randomised, double blind, placebo-controlled trial

Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute0 sites528 target enrollmentJuly 13, 2006

Overview

Phase
未知
Intervention
Not specified
Conditions
Chronic kidney disease in renal transplant patients
Sponsor
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Enrollment
528
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 13, 2006
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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