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Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

NCT ID: NCT00261820

Last Updated: 2006-05-19

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

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-01-31

Brief Summary

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Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.

Detailed Description

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Conditions

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Graft Rejection Kidney Failure Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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tacrolimus

Intervention Type DRUG

mycophenolate mofetil

Intervention Type DRUG

methylprednisolone

Intervention Type DRUG

prednisolone

Intervention Type DRUG

sirolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age: 18 and \< 65 years
* End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor
* Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant

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
* Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Belgium, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For France, [email protected]

Other Identifiers

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0468E1-100194

Identifier Type: -

Identifier Source: org_study_id