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

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00502242

Purpose

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.

Condition	Intervention	Phase
Kidney Transplant Kidney Transplantation Renal Transplant	Drug: sirolimus Drug: ramipril	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus Ramipril

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

The primary endpoint is the time to initiation of losartan therapy initiation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	375
Study Start Date:	October 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: sirolimus
B: Active Comparator	Drug: ramipril

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502242

Show 60 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0468E5-4439
Study First Received:	July 16, 2007
Last Updated:	January 22, 2010
ClinicalTrials.gov Identifier:	NCT00502242 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Antibiotics, Antineoplastic
Immunosuppressive Agents
Ramipril
Pharmacologic Actions
Protease Inhibitors
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Angiotensin-Converting Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010