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Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients

NCT ID: NCT00149903

Last Updated: 2016-11-18

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Brief Summary

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Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.

Detailed Description

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Conditions

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Renal Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Mycophenolate sodium (enteric coated)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant,
* treated with cyclosporine and corticosteroids as primary immunosuppression.

Exclusion Criteria

* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ
* Patients who have received an investigational drug within four weeks prior to study entry
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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General Hospital, Friendship Hospital, Beijing, No 1 Hospital Peking University, Beijing China; Shanghai No 1 Hospital, Shanghai China; Changzheng Hospital, Shanghai, China; Shanghai Ruij

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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CERL080A2305

Identifier Type: -

Identifier Source: org_study_id