Trial record 1 of 3 for:    Ramipril on Urinary Protein Excretion
Previous Study | Return to List | Next Study

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
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
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 April 17, 2014