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

Last updated on November 8, 2019

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Study Location
Pfizer Investigational Site
Los Angeles, California, 90033-4612 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects who are currently receiving, or have received within 4 weeks before
enrollment, RAAS blockade.

- Subjects with a calculated GFR 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.

NCT00502242
Pfizer
Completed
Study Evaluating The Effect Of Ramipril On Urinary Protein Excretion In Renal Transplant Patients Converted To Sirolimus

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Descriptive Information
Brief Title  ICMJE Study Evaluating The Effect Of Ramipril On Urinary Protein Excretion In Renal Transplant Patients Converted To Sirolimus
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Kidney Transplant
Intervention  ICMJE
  • Drug: ramipril
    Capsule - initial treatment is 5 mg (active)- oral - once per day
  • Drug: ramipril
    Capsule - initial treatment is 5 mg (placebo) - oral - once per day
Study Arms  ICMJE
  • Active Comparator: A
    Capsule - initial treatment is 5 mg (active)- oral - once per day
    Intervention: Drug: ramipril
  • Placebo Comparator: B
    Capsule - initial treatment is 5 mg (placebo) - oral - once per day
    Intervention: Drug: ramipril
Publications *Mandelbrot DA, Alberú 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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2013)
229
Original Enrollment  ICMJE
 (submitted: July 16, 2007)
375
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion DateSeptember 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Brazil,   Canada,   Germany,   Hungary,   Israel,   Mexico,   Poland,   South Africa,   United States
Removed Location CountriesBelgium,   Colombia,   Egypt,   France,   Italy,   Spain,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT00502242
Other Study ID Numbers  ICMJE 0468E5-4439
B1741001
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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