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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788567
First Posted: November 11, 2008
Last Update Posted: November 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Kidney Transplantation Drug: mycophenolate mofetil Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, H1T 2M4
Montreal, Quebec, Canada, H2L 4M1
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

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
First Submitted: November 10, 2008
First Posted: November 11, 2008
Last Update Posted: November 3, 2015
Last Verified: November 2015

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