Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation

Completed · Phase 4

Conditions studied: Kidney Transplantation

In brief

This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have undergone kidney transplantation. Participants will be randomized to one of three dosing regimens to receive concentration-controlled MMF with reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard CNI. Participants will be followed for 20-24 months after randomization.

Key facts

Study ID

NCT00087581

Run by

Hoffmann-La Roche

People needed

720

Starts

2004-06-01

Expected to finish

2007-09-01

Last updated by the study team

2016-11-07

Who can join

Age: 13 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females 13-75 years of age
• Single organ recipient (kidney only) from living (related or unrelated) or cadaveric heart-beating donors
• Receiving first or second kidney transplant

You may not qualify if…

• Immunosuppressive therapy (except for 48 hours prior to transplantation and 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)

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Denver, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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