A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.

Roche

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: tacrolimus, standard dose; Drug: corticosteroids; Drug: tacrolimus, low dose; Drug: mycophenolate mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758602

ML21740

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid + tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or 2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3 followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Enrollment: 210 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, <=75 years of age;
• single organ recipients of renal allograft;
• negative pregnancy test for women of childbearing potential; reliable contraception must be used before starting drug therapy, until 6 weeks after the last dose of study medication.

Exclusion criteria

• severe gastrointestinal disease which may influence the absorption of oral drug therapy;
• severe infection, HIV or active hepatitis;
• active gastric ulcers;
• malignancy other than cured skin cancer;
• severe anemia, leucopenia or thrombocytopenia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

MMF, Standard Dose Tacrolimus

Active Comparator group

Description:

Participants received mycophenolate mofetil (MMF) 0.75 to (-) 1 gram (g), orally (PO), twice daily (BID) from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 milligrams per kilogram (mg/kg), PO, BID to reach a target trough dose of 8-10 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice.

Treatment:

Drug: corticosteroids

Drug: tacrolimus, standard dose

Drug: mycophenolate mofetil

MMF, Low Dose Tacrolimus

Experimental group

Description:

Participants received MMF 0.75-1 g, PO, BID from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 mg/kg, PO, BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to 0.05-0.08 mg/kg, PO, BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice.

Treatment:

Drug: corticosteroids

Drug: mycophenolate mofetil

Drug: tacrolimus, low dose