CLEAR Study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants

Roche

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: mycophenolate mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00788567

ML18496

Details and patient eligibility

About

This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• recipients of a primary kidney transplant.

Exclusion criteria

• positive for HIV-1, human T-cell leukemia/lymphoma virus-1 (HTLV-1), or hepatitis B surface antigen;
• positive for hepatitis C virus, with moderate or severe liver disease;
• active malignancy or history of malignancy, excluding skin cancer (basal or squamous cell) that has been adequately treated;
• need for maintenance corticosteroids for another condition.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

136 participants in 1 patient group

1

Experimental group

Treatment:

Drug: mycophenolate mofetil