Official Title: “A Randomized, Placebo Controlled, Double-Blind Comparative Study Evaluating the Effect of Ramipril On Urinary Protein Excretion in Maintenance Renal Transplant Patients Converted to Sirolimus”

The primary objective of the study is to determine the efficacy of ramipril in preventing a urinary protein to creatinine ratio (U p/c) greater than 0.5 following conversion to sirolimus from a calcineurin inhibitor (CNI) in maintenance kidney transplant patients.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Drug: sirolimus
• Drug: ramipril

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B

Primary Measures

• The primary endpoint is the time to initiation of losartan therapy initiation
  • Time Frame: 1 year
    Safety Issue?: Yes

Secondary Measures

• Proportion of subjects with Up/c and/or Ualb < 0.5 following conversion to sirolimus;Change of U p/c and Ualb/c from baseline;Proportion of subjects that discontinue sirolimus therapy; Abbreviated MDRD GFR following conversion to sirolimus.
  • Time Frame: 1 year
    Safety Issue?: Yes

Inclusion Criteria

• Treatment with corticosteroids at a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12mg/day for methylprednisolone), the alternate day equivalent, or a steroid-free regiment for a minimum of 12 weeks before randomization. Subjects may be treated with either MMF (>500mg/day), mycophenolate sodium (MPS) (>360 mg/day) or AZA (>50mg/day) and must be taking a minimum of 2 immunosuppressive drugs if on a steroid-free regimen.
• Receiving CsA or TAC since the first month post-transplant.
• Subject is 6 to 60 months after renal transplantation.

Exclusion Criteria

• Subjects with a calculated GFR < 40mL/min (per the Modification of Diet in Renal
• Disease [MDRD-7] or abbreviated MDRD formula).
• Subjects with a U p/c, or a urine albumin to creatinine ratio (U alb/c) of >0.3.
• Subjects with a history of uncontrolled systolic blood pressure, of < 140 mm Hg.
• Additional Inclusion / Exclusion Criteria apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Overall Contact: Trial Manager  clintrialparticipation@wyeth.com

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00502242

Study ID Number: 0468E5-4439

ClinicalTrials.gov Identifier: NCT00502242

Health Authority: United States: Food and Drug Administration