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

Tracking Information

First Received Date ^ICMJE

July 12, 2004

Last Updated Date

May 13, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Efficacy: Proportion of patients experiencing treatment failure within 12 months post-transplantation, 12 months' renal allograft function as measured by glomerular filtration rate

Change History

Complete list of historical versions of study NCT00087581 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Safety: Adverse events

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Kidney Transplantation

Intervention ^ICMJE

Drug: mycophenolate mofetil [CellCept]
Drug: Cyclosporine or tacrolimus

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

717

Completion Date

January 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

13 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00087581

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

ML17225

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP