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

NCT00502242 | Completed Phase 4 Results DMC

• 2 other identifiers: 0468E5-4439B1741001
• Study Type: interventional
• Target: 229
• Locations: 11 countries
• Sites: 48

Brief Summary

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.

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Had Initiated Losartan Therapy at 52 Weeks Following Conversion to SRL

  The event for each participant was defined as the initiation of losartan while on SRL and ramipril/placebo combination therapy. Participants who started losartan prior to SRL administration were not counted as events. Percentage was estimated using Kaplan-Meier method for time to event data.

  From Day 1 of SRL conversion to 52 weeks after conversion

Secondary Outcomes (23)

• Percentage of Participants Who Had a Dose Escalation in Randomized Test Article (Ramipril or Placebo) by 52 Weeks Following Conversion to SRL

  From Day 1 of SRL conversion to 52 weeks after conversion

• Percentage of Participants With U p/c <0.5 at 24 and 52 Weeks Following Conversion to Sirolimus

  24 weeks and 52 weeks after conversion

• Percentage of Participants With Urinary Albumin to Creatinine Ratio (U Alb/c) <0.5 at 24 and 52 Weeks Following Conversion to SRL

  24 weeks and 52 weeks after conversion

• Percentage of Participants With Both U Alb/c <0.5 and U p/c <0.5 at 24 and 52 Weeks Following Conversion to SRL

  24 weeks and 52 weeks after conversion

• U p/c at Baseline and Weeks 3, 4, 8, 12, 24, 30, 36, and 52 Following Conversion to SRL

  Baseline and 3, 4, 8, 12, 24, 30, 36, and 52 weeks after conversion

Study Arms (2)

A

ACTIVE COMPARATOR

Capsule - initial treatment is 5 mg (active)- oral - once per day

Drug: ramipril

B

PLACEBO COMPARATOR

Capsule - initial treatment is 5 mg (placebo) - oral - once per day

Drug: ramipril

Interventions

ramipril DRUG

Capsule - initial treatment is 5 mg (active)- oral - once per day

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (49)

Pfizer Investigational Site

Los Angeles, California, 90033-4612, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90033, United States

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Pfizer Investigational Site

San Francisco, California, 94115, United States

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Pfizer Investigational Site

Aurora, Colorado, 80045, United States

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Pfizer Investigational Site

Denver, Colorado, 80218, United States

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Pfizer Investigational Site

Gainesville, Florida, 32610, United States

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Pfizer Investigational Site

Chicago, Illinois, 60637, United States

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Pfizer Investigational Site

Iowa City, Iowa, 52242, United States

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Pfizer Investigational Site

Lexington, Kentucky, 40536-0293, United States

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Pfizer Investigational Site

Portland, Maine, 04102, United States

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Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

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Pfizer Investigational Site

Springfield, Massachusetts, 01107, United States

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Pfizer Investigational Site

Springfield, Massachusetts, 01199, United States

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Pfizer Investigational Site

Gosse Pointe, Michigan, 48236, United States

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Pfizer Investigational Site

Buffalo, New York, 14215, United States

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Pfizer Investigational Site

Valhalla, New York, 10595, United States

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Pfizer Investigational Site

Cleveland, Ohio, 44106, United States

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Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

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Pfizer Investigational Site

Harrisburg, Pennsylvania, 17104, United States

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Pfizer Investigational Site

Philadelphia, Pennsylvania, 19102-1192, United States

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Pfizer Investigational Site

Philadelphia, Pennsylvania, 19102, United States

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Pfizer Investigational Site

Philadelphia, Pennsylvania, 19107, United States

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Pfizer Investigational Site

Providence, Rhode Island, 02903, United States

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Pfizer Investigational Site

Charleston, South Carolina, 29425-6290, United States

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Pfizer Investigational Site

Capital Federal, Buenos Aires, 1425, Argentina

Location

Pfizer Investigational Site

San Martín, Buenos Aires, 1650 CP, Argentina

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Pfizer Investigational Site

Buenos Aires, 1181, Argentina

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Pfizer Investigational Site

Córdoba, 5016, Argentina

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Pfizer Investigational Site

Brisbane, Queensland, 4029, Australia

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Pfizer Investigational Site

North Terrace, 5000, Australia

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Pfizer Investigational Site

Woodville South, SA 5011, Australia

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Pfizer Investigational Site

Linz, 4020, Austria

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Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, 21041-030, Brazil

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Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

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Pfizer Investigational Site

São Paulo, São Paulo, 01323-001, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01323-030, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04038-002, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04039-033, Brazil

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 4M1, Canada

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Pfizer Investigational Site

Erlangen, 91054, Germany

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Pfizer Investigational Site

Szeged, 6720, Hungary

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Pfizer Investigational Site

Petah Tikva, 49100, Israel

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Pfizer Investigational Site

Mexico City, Mexico City, 14000, Mexico

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Pfizer Investigational Site

Veracruz, Mexico, 91700, Mexico

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Pfizer Investigational Site

Szczecin, 70-111, Poland

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Pfizer Investigational Site

Johannesburg, Gauteng, 2193, South Africa

Location

Pfizer Investigational Site

Cape Town, Western Cape, 7925, South Africa

Location

Pfizer Investigational Site

Cape Town, Western Cape, 8001, South Africa

Location

Related Publications (2)

• Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.

  PMID: 39082471 DERIVED

• Mandelbrot DA, Alberu J, Barama A, Marder BA, Silva HT Jr, Flechner SM, Flynn A, Healy C, Li H, Tortorici MA, Schulman SL. Effect of Ramipril on Urinary Protein Excretion in Maintenance Renal Transplant Patients Converted to Sirolimus. Am J Transplant. 2015 Dec;15(12):3174-84. doi: 10.1111/ajt.13384. Epub 2015 Jul 14.

  PMID: 26176342 DERIVED

MeSH Terms

Interventions

Ramipril

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 17, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 27, 2014
• Results First Posted: August 27, 2014

Record last verified: 2014-08

Locations

PL (1); DE (1); IL (1); AU (3); US (24); CA (1); ME (2); ZA (3); BR (7); HU (1); AR (4)