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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00502242
First received: July 16, 2007
Last updated: October 7, 2013
Last verified: October 2013
  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
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:


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 ]

Enrollment: 229
Study Start Date: December 2007
Study Completion Date: September 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 50 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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: October 7, 2013
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
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014