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

Roche

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: antibody induction; Drug: corticosteroid; Drug: Cyclosporine; Drug: mycophenolate mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01292226

ML19835

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Mycophenolate Mofetil Monotherapy

Experimental group

Description:

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.

Treatment:

Drug: corticosteroid

Drug: mycophenolate mofetil

Drug: antibody induction

Drug: Cyclosporine