Study of Therapeutic Monitoring of CellCept (Mycophenolate Mofetil) After Kidney Transplantation - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by (Responsible Party):	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00087581

Purpose

This 3 arm study will evaluate the efficacy and safety of various dosing regimens of CellCept combined with various dosing regimens of cyclosporine or tacrolimus in kidney transplantation patients. Patients will be randomized to one of 3 dosing regimens to receive concentration-controlled CellCept with reduced cyclosporine or tacrolimus, concentration-controlled CellCept with standard cyclosporine or tacrolimus, or fixed-dose CellCept (1g bid) with standard cyclosporine or tacrolimus. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Kidney Transplantation	Drug: mycophenolate mofetil [CellCept] Drug: Cyclosporine or tacrolimus	Phase IV

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 Various Dosing Regimens of CellCept Combined With Various Dosing Regimens of Cyclosporine or Tacrolimus on Treatment Failure in Kidney Transplantation Patients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients experiencing treatment failure [ Time Frame: Within 12 months post-transplant ] [ Designated as safety issue: No ]
Renal allograft function (by GFR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	717
Study Completion Date:	January 2008

Arms	Assigned Interventions
Experimental: 1	Drug: mycophenolate mofetil [CellCept] Concentration-controlled Drug: Cyclosporine or tacrolimus Reduced
Experimental: 2	Drug: mycophenolate mofetil [CellCept] Concentration-controlled Drug: Cyclosporine or tacrolimus Standard, as prescribed
Experimental: 3	Drug: mycophenolate mofetil [CellCept] 1g po bid Drug: Cyclosporine or tacrolimus Standard, as prescribed

Eligibility

Ages Eligible for Study:	13 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female patients 13-75 years of age
single organ recipient (kidney only) from living (related or unrelated) or cadaveric heart-beating donors
patient receiving first or second kidney transplant

Exclusion Criteria:

immunosuppressive therapy (except corticosteroid treatment) within previous 28 days for a first transplant and 3 months for a second transplant
history of malignancy in last 5 years (except successfully treated localized non-melanoma skin cancer)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087581

Show 57 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00087581 History of Changes
Other Study ID Numbers:	ML17225
Study First Received:	July 12, 2004
Last Updated:	September 26, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents

Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012