CLEAR Study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants
A Randomized, Open-label Study of the Achievement of a Mycophenolic Acid Therapeutic Window During Treatment With 2 Dosing Regimens of Oral CellCept Administered as a Component of Standard Immunosuppressive Therapy in Patients With Kidney Transplants
1 other identifier
interventional
136
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2005
Typical duration for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 10, 2008
CompletedFirst Posted
Study publicly available on registry
November 11, 2008
CompletedNovember 3, 2015
November 1, 2015
2.9 years
November 10, 2008
November 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients achieving therapeutic window by Day 5\n
Secondary Outcomes (1)
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
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients \>=18 years of age;
- recipients of a primary kidney transplant.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Edmonton, Alberta, T6G 2S2, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Vancouver, British Columbia, V6Z 1Y6, Canada
Unknown Facility
Halifax, Nova Scotia, B3H2Y9, Canada
Unknown Facility
Toronto, Ontario, M5G 2C4, Canada
Unknown Facility
Montreal, Quebec, H1T 2M4, Canada
Unknown Facility
Montreal, Quebec, H2L 4M1, Canada
Unknown Facility
Québec, Quebec, G1R 2J6, Canada
Unknown Facility
Saskatoon, Saskatchewan, S7N 0W8, Canada
Related Publications (1)
Gourishankar S, Houde I, Keown PA, Landsberg D, Cardella CJ, Barama AA, Dandavino R, Shoker A, Pirc L, Wrobel MM, Kiberd BA. The CLEAR study: a 5-day, 3-g loading dose of mycophenolate mofetil versus standard 2-g dosing in renal transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1282-9. doi: 10.2215/CJN.09091209. Epub 2010 May 24.
PMID: 20498245DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2008
First Posted
November 11, 2008
Study Start
June 1, 2005
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
November 3, 2015
Record last verified: 2015-11