Study Evaluating The Effect Of Ramipril On Urinary Protein Excretion In Renal Transplant Patients Converted To Sirolimus
This study is currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00502242
First received: July 16, 2007
Last updated: April 29, 2013
Last verified: April 2013
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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 ]
| 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
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Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 50 Study LocationsSponsors 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: | April 29, 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 May 23, 2013