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

Phase 3

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: mycophenolate mofetil

• Registration Number: NCT00788567
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	mycophenolate mofetil	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving therapeutic window by Day 5\n

Secondary Outcome Measures

Name	Time	Method
Efficacy: Achieving therapeutic window at Day 3, maintaining therapeutic window at day of discharge, Months 1, 3, and 6\nSafety: Renal function, opportunistic infections, malignancies, and adverse events\n