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Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients

NCT ID: NCT00199667

Last Updated: 2008-12-16

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Brief Summary

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Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and then minimize side effects in the long term. However definitive proof is still lacking. We conducted a randomized study in 11 french centers and included 137 kidney transplant recipients (PRA\<50%) receiving a classical immunosuppressant regimen with basiliximab, Csa, MMF and steroids. The "fixed dose" group received 2 g of MMF a day. The "concentration controlled" group received MMF dose adapted to the area under the concentration curve (AUC) of MPA, with a target of 40 h.mg/L. After transplantation AUCs were calculated with a Bayesian estimator using a 3-point limited sampling strategy on day 7, 14, and months 1, 3, 6 , 12 in both groups (values note communicated to the physicians in the "fixed dose" group.

Detailed Description

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Conditions

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Kidney Transplant Recipients

Keywords

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MMF, Monitoring, area under curve (AUC), 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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Mycophenolate Mofetil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients received a first or a second kidney transplantation
* patients with panel reactive antibody \<or= 50 %
* patients with cellcept treatment since fewer 3 days
* patients receiving or being received ciclosporine treatment
* patients without retention, important hepatic cytolysis
* patients without post-surgical complication or intercurrent disease
* informed consent signed

Exclusion Criteria

* patients included in other study
* patients with MMF or mycophenolic acid hypersensibility or MMF contraindication
* patients with gastroduodenal disorder before the beginning of the study
* pregnant women or without contraception
* patients with rapamycin or analogous
* patients with toxicomania or psychiatric disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

University Hospital, Limoges

OTHER

Sponsor Role lead

Principal Investigators

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Yann LE MEUR, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

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Néphrologie

Amiens, , France

Site Status

Néphrologie

Angers, , France

Site Status

Néphrologie

Caen, , France

Site Status

Néphrologie

Limoges, , France

Site Status

Néphrologie

Paris, , France

Site Status

Néphrologie

Poitiers, , France

Site Status

Néphrologie

Reims, , France

Site Status

Néphrologie

Rouen, , France

Site Status

Néphrologie

Strasbourg, , France

Site Status

Néphrologie

Toulouse, , France

Site Status

Néphrologie

Tours, , France

Site Status

Countries

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France

Other Identifiers

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I02013

Identifier Type: -

Identifier Source: org_study_id