Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00788567
First received: November 10, 2008
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Kidney Transplantation
Drug: mycophenolate mofetil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients achieving therapeutic window by Day 5\n [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: June 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: mycophenolate mofetil
1
Other Name: CellCept

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788567

Locations
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2S2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada, H1T 2M4
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00788567     History of Changes
Other Study ID Numbers: ML18496
Study First Received: November 10, 2008
Last Updated: November 3, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014