Study Evaluating The Effect Of Ramipril On Urinary Protein Excretion In Renal Transplant Patients Converted To Sirolimus

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.

Intervention(s) in this Clinical Trial

• Drug: ramipril
  • Capsule - initial treatment is 5 mg (active)- oral - once per day
• Drug: ramipril
  • Capsule - initial treatment is 5 mg (placebo) - oral - once per day

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Capsule - initial treatment is 5 mg (active)- oral - once per day
• Placebo Comparator: B
  • Capsule - initial treatment is 5 mg (placebo) - oral - once per day

Primary Measures

• Time to losartan therapy initiation
  • Time Frame: 1 year
    Safety Issue?: Yes

Secondary Measures

• Proportion of subjects with U p/c and/or Ualb < 0.5 following conversion to sirolimus
  • Time Frame: 1 year
    Safety Issue?: Yes
• Change of urinary protein to creatinine ratio (U p/c) and urinary albumin to creatinine ratio (U alb/c) from baseline
  • Time Frame: 1 year
    Safety Issue?: Yes
• Proportion of subjects that discontinue sirolimus therapy
  • Time Frame: 1 year
    Safety Issue?: Yes
• Abbreviated MDRD GFR (Modification of Diet in Renal Disease Glomerular Filtration Rate) following conversion to sirolimus
  • Time Frame: 1 year
    Safety Issue?: Yes

Inclusion Criteria:

• Receiving cyclosporine (CsA) or tacrolimus (TAC) since the first month post-transplant.
• In addition to a calcineurin inhibitor (CNI), subjects must be treated with either corticosteroids at a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12mg/day for methylprednisolone or the alternate day equivalent) or a steroid-free regimen for a minimum of 12 weeks before randomization or either MMF (>/=500mg/day), mycophenolate sodium (MPS) (>/=360 mg/day) or AZA (>/=50mg/day).
• Subjects must be taking a minimum of 2 immunosuppressive drugs if on a steroid-free regimen.
• Subject is 3 to 60 months after renal transplantation.
• Subject is greater than 12 weeks after treatment for any acute rejection.

Exclusion Criteria:

• Subjects who are currently receiving, or have received within 4 weeks before enrollment, RAAS blockade.
• Subjects with a calculated GFR < 40mL/min (per the Modification of Diet in Renal
• Disease [MDRD-7] or abbreviated MDRD formula).
• Subjects with a urine protein to creatinine ratio (U p/c) of >0.3.
• Subjects with a history of uncontrolled systolic blood pressure (SBP >140 mm Hg).
• Subjects with severe hepatic impairment (Grade C Child-Pugh score). 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 Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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