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Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

NCT ID: NCT00452361

Last Updated: 2012-09-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-08-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Sirolimus therapy

Group Type EXPERIMENTAL

Sirolimus+MMF or MPS or AZA+Steroid

Intervention Type DRUG

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.

2

Calcineurin Inhibitor therapy (either cyclosporine or tacrolimus)

Group Type ACTIVE_COMPARATOR

Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Select Cities, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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0468H-101864

Identifier Type: -

Identifier Source: org_study_id