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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
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: ramipril	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Time to losartan therapy initiation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of subjects with urinary protein to creatinine ratio and/or urinary albumin to creatinine ratio < 0.5 following conversion to sirolimus [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Change of urinary protein to creatinine ratio (U p/c) and urinary albumin to creatinine ratio (U alb/c) from baseline and after conversion to sirolimus [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Proportion of subjects that discontinue sirolimus therapy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Abbreviated MDRD GFR (Modification of Diet in Renal Disease Glomerular Filtration Rate) following conversion to sirolimus [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Fraction of albumin to protein in urine at baseline and after conversion to sirolimus [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	440
Study Start Date:	December 2007
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Capsule - initial treatment is 5 mg (active)- oral - once per day	Drug: ramipril 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	Drug: ramipril Capsule - initial treatment is 5 mg (placebo) - oral - once per day

Eligibility

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

Criteria

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.

Contacts and Locations

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 50 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00502242 History of Changes
Other Study ID Numbers:	0468E5-4439, B1741001
Study First Received:	July 16, 2007
Last Updated:	April 23, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Ramipril
Sirolimus
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents

Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2012