Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-31

Study Completion Date

2004-06-30

Brief Summary

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To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.

Detailed Description

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Conditions

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Renal Transplantation

Keywords

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Renal allograft Renal Kidney Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Sirolimus

Intervention Type DRUG

cyclosporine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor.
* Women who are of childbearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of sirolimus

Exclusion Criteria

* Evidence of active systemic or localized major infection at the time of initial sirolimus administration
* Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
* Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

References

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Friend P, Russ G, Oberbauer R, Murgia MG, Tufveson G, Chapman J, Blancho G, Mota A, Grandaliano G, Campistol JM, Brault Y, Burke JT; Rapamune Maintenance Regimen (RMR) Study Group. Incidence of anemia in sirolimus-treated renal transplant recipients: the importance of preserving renal function. Transpl Int. 2007 Sep;20(9):754-60. doi: 10.1111/j.1432-2277.2007.00506.x. Epub 2007 Jun 12.

Reference Type DERIVED

PMID: 17565578 (View on PubMed)

Other Identifiers

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0468H1-310

Identifier Type: -

Identifier Source: org_study_id