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Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

Last updated on December 15, 2017

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Study Location
Select Cities, , Taiwan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplantation
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

- Subjects must be at least 18 years of age.

- Subjects who are 6 to 60 months after renal transplantation.

- Subjects who have a stable graft function.

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

- Subjects with active major infection, including HIV, decreased platelets, elevated
lipids, or multiple organ transplants.

NCT00452361
Pfizer
Terminated
Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

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Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient
A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipient
This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).

This open-label, randomized, parallel-group, comparative, outpatient study will be conducted in multiple centers in Taiwan.

The study will randomize approximately 120 patients. 80 patients will be randomized to the SRL therapy group (conversion from CI- to SRL-based immunosuppression: group A) and 40 patients to the CI therapy group (continued CI therapy: group B).

Dosage and Administration

SRL Therapy: At the time of randomization on day 1, each patient will have been receiving:

  • triple therapy with a CI (tacrolimus or CsA) that began at the time of transplantation or within 2 weeks thereafter AND
  • corticosteroids corresponding to a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent for at least 12 weeks before randomization, PLUS
  • either MMF (minimum dose 500 mg/day)/MPS (minimum dose 360 mg/day) or AZA (minimum dose 50 mg/day) for at least 12 weeks before randomization.

SRL will be added to the immunosuppressive regimen for Group A. Group B will continue on this CI immunosuppressive regimen.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: Sirolimus+MMF or MPS or AZA+Steroid
    Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
  • Drug: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid

    The maintenance dose of:

    1. MMF will not exceed 1500 mg/day or PMS will not exceed 1080 mg/day
    2. AZA will not exceed 75 mg/day

    Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be:

    1. continued for the entire 104-week period of randomized therapy
    2. subsequently discontinued
    3. restarted after discontinuation
  • Experimental: 1
    Sirolimus therapy
    Intervention: Drug: Sirolimus+MMF or MPS or AZA+Steroid
  • Active Comparator: 2
    Calcineurin Inhibitor therapy (either cyclosporine or tacrolimus)
    Intervention: Drug: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must be at least 18 years of age.
  • Subjects who are 6 to 60 months after renal transplantation.
  • Subjects who have a stable graft function.

Exclusion Criteria:

  • Subjects with active major infection, including HIV, decreased platelets, elevated lipids, or multiple organ transplants.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00452361
0468H-101864
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2012

ICMJE     Data element required by the

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

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