Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) 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

PHASE4

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-03-31

Brief Summary

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This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.

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Detailed Description

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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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reduced Tacrolimus

Group Type EXPERIMENTAL

EC-MPS, Tacrolimus

Intervention Type DRUG

Reference Tacrolimus

Group Type ACTIVE_COMPARATOR

EC-MPS, Tacrolimus

Intervention Type DRUG

Interventions

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EC-MPS, Tacrolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
* The renal cold ischemic time (CIT) must be \<30 hours
* The age of the donor must be between 10 and 65 years

Exclusion Criteria

* Patients who have previously received an organ transplant
* Patients who are recipients of a multiple organ transplants
* Recipients of non heart-beating donor organs
* ABO incompatibility against the donor

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No