A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-09-30

Brief Summary

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This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.

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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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mycophenolate Mofetil Monotherapy

Participants received an initial dose of mycophenolate mofetil (MMF), 1 gram (g), orally (PO), twice per day (BID), within 5 days of transplant for 24 weeks. Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.

Group Type EXPERIMENTAL

mycophenolate mofetil

Intervention Type DRUG

1 g PO BID for 24 weeks

antibody induction

Intervention Type DRUG

According to manufacturer recommendation

Cyclosporine

Intervention Type DRUG

According to manufacturer recommendation

corticosteroid

Intervention Type DRUG

According to manufacturer recommendation

Interventions

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mycophenolate mofetil

1 g PO BID for 24 weeks

Intervention Type DRUG

antibody induction

According to manufacturer recommendation

Intervention Type DRUG

Cyclosporine

According to manufacturer recommendation

Intervention Type DRUG

corticosteroid

According to manufacturer recommendation

Intervention Type DRUG

Other Intervention Names

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CellCept

Eligibility Criteria

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Inclusion Criteria

* Adult patients, 18 to 65 years of age
* Patients undergoing primary kidney transplantation

Exclusion Criteria

* Recipients of multiple organ transplants
* Prior therapy with CellCept
* Presence or history of malignancies, except for successfully treated basal or squamous cell carcinoma of the skin
* Active peptic ulcer or active serious digestive system disease that may affect the absorption of CellCept

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No