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

Sponsored by:	Hoffmann-La Roche
Information provided by:	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

MedlinePlus related topics: Kidney Transplantation

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

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

Arms	Assigned Interventions
1: Experimental	Drug: mycophenolate mofetil [CellCept] Concentration-controlled Drug: Cyclosporine or tacrolimus Reduced
2: Experimental	Drug: mycophenolate mofetil [CellCept] Concentration-controlled Drug: Cyclosporine or tacrolimus Standard, as prescribed
3: Experimental	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, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML17225
Study First Received:	July 12, 2004
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00087581
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cyclosporine
Clotrimazole
Miconazole
Tioconazole

Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 15, 2009