Know Cancer

or
forgot password

A Randomized, Open Label Study Comparing the Effect of CellCept Combined With Low Dose Versus Standard Dose Tacrolimus, and Corticosteroids, on Kidney Function in Renal Transplantation Patients


Phase 4
N/A
75 Years
Not Enrolling
Both
Kidney Transplantation

Thank you

Trial Information

A Randomized, Open Label Study Comparing the Effect of CellCept Combined With Low Dose Versus Standard Dose Tacrolimus, and Corticosteroids, on Kidney Function in Renal Transplantation Patients


Inclusion Criteria:



- adult patients, <=75 years of age;

- single organ recipients of renal allograft;

- negative pregnancy test for women of childbearing potential; reliable contraception
must be used before starting drug therapy, until 6 weeks after the last dose of study
medication.

Exclusion Criteria:

- severe gastrointestinal disease which may influence the absorption of oral drug
therapy;

- severe infection, HIV or active hepatitis;

- active gastric ulcers;

- malignancy other than cured skin cancer;

- severe anemia, leucopenia or thrombocytopenia.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Glomerular filtration rate; chronic allograft damage.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

China: State Fodd and Drug Administration

Study ID:

ML21740

NCT ID:

NCT00758602

Start Date:

October 2008

Completion Date:

January 2011

Related Keywords:

  • Kidney Transplantation

Name

Location