Study Evaluating the Effect of Ramipril on Urinary Protein Excretion in Renal Transplant Patients Converted to Sirolimus

Condition(s) targeted: Kidney Transplant; Kidney Transplantation; Renal Transplant

Intervention: sirolimus (Drug); ramipril (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

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.

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

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

Primary outcome: The primary endpoint is the time to initiation of losartan therapy initiation

Secondary outcome: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 regimen 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 3 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 (cannot sustain a SBP

< 140 mm Hg).

- Subjects with severe hepatic impairment (Grade C Child-Pugh score) Additional

Inclusion / Exclusion Criteria apply.

Trial Manager, Email: clintrialparticipation@wyeth.com

Buenos Aires, Argentina; Not yet recruiting

Cordoba, Argentina; Recruiting

Vienna, Austria; Not yet recruiting

Edegem, Belgium; Not yet recruiting

Sao Paulo, Brazil; Not yet recruiting

Rio de Janeiro, Brazil; Not yet recruiting

Andar, Brazil; Not yet recruiting

Porto Alegre, Brazil; Not yet recruiting

Quebec G1R2J6, Canada; Recruiting

Cairo, Egypt; Not yet recruiting

Mansoura, Egypt; Not yet recruiting

Tours, France; Not yet recruiting

Montpellier, France; Not yet recruiting

Berlin, Germany; Not yet recruiting

Gent, Germany; Not yet recruiting

Foggia, Italy; Not yet recruiting

Bari, Italy; Not yet recruiting

Mexico City 14000, Mexico; Not yet recruiting

Cantabria, Spain; Recruiting

Barcelona, Spain; Not yet recruiting

Barcelona, Spain; Recruiting

Istanbul, Turkey; Not yet recruiting

Antalya, Turkey; Not yet recruiting

San Francisco, California 94115, United States; Recruiting

San Diego, California 92103, United States; Not yet recruiting

Los Angeles, California 90033, United States; Recruiting

Denver, Colorado 80262, United States; Recruiting

Denver, Colorado 80218, United States; Recruiting

Nurnberg, Erlangen, Germany; Not yet recruiting

Metepec, Estado de Mexico 52140, Mexico; Not yet recruiting

Gainesville, Florida 32610, United States; Not yet recruiting

Miami, Florida 33136, United States; Not yet recruiting

Tampa, Florida 33606, United States; Not yet recruiting

Johannesburg, Gauteng, South Africa; Not yet recruiting

Atlanta, Georgia 30322, United States; Not yet recruiting

Chicago, Illinois 60637, United States; Recruiting

Chicago, Illinois 60612, United States; Terminated

Iowa City, Iowa 52242, United States; Recruiting

Lexington, Kentucky 40536, United States; Recruiting

New Orleans, Louisiana 70121, United States; Recruiting

Portland, Maine 04102, United States; Recruiting

Boston, Massachusetts 02215, United States; Recruiting

Detroit, Michigan 48236, United States; Recruiting

Detroit, Michigan 48202, United States; Terminated

Livingston, New Jersey 07039, United States; Recruiting

Buffalo, New York 14203, United States; Not yet recruiting

Valhalla, New York 10595, United States; Not yet recruiting

Linz, Oberosterrei, Austria; Recruiting

Cleveland, Ohio 44106-5048, United States; Recruiting

Cleveland, Ohio 44195, United States; Recruiting

Philadelphia, Pennsylvania 19107, United States; Recruiting

Harrisburg, Pennsylvania 17105, United States; Recruiting

Montreal, Quebec CA, Canada; Recruiting

Montreal, Quebec H2L4Mi, Canada; Recruiting

Providence, Rhode Island 02903, United States; Recruiting

Charleston, South Carolina 38104, United States; Recruiting

Graz, Steiremark, Austria; Not yet recruiting

Houston, Texas 77030, United States; Not yet recruiting

Cape Town, Western Cape, South Africa; Not yet recruiting

Madison, Wisconsin 53713, United States; Terminated

Starting date: October 2007
Ending date: June 2010
Last updated: August 14, 2009