Trial information
A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients
Status: Completed
Protocol number: PA16290
Sponsor: Hoffmann-La Roche Ltd/Inc/AG
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of CellCept, sirolimus, and corticosteroids with or without daclizumab on the pharmacokinetics of mycophenolic acid in renal transplant patients
Brief summary: This study will assess the pharmacokinetics, safety and efficacy of CellCept in combination with Rapamune (sirolimus) or Neoral (Cyclosporine) when used in conjunction with Zenapax(daclizumab) and corticosteroids in patients undergoing kidney transplantation. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is 45.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Kidney Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil[CellCept]
Primary outcome: 1. MPA and MPAG blood concentrations; MPA and MPAG trough plasma concentrations
Key secondary outcomes: 1. Safety: Vital signs, laboratory analyses, AEs, OIs, malignancies, deaths. Efficacy: Acute rejection or treatment failure, time to first acute rejection, patient and graft survival
Inclusion criteria:
- adult patients 18-75 years of age;
- first kidney transplant (excluding recipients of HLA-identical living related kidney transplants);
- non-smokers.
Exclusion criteria:
- African-Americans;
- previous treatment with Zenapax;
- history of malignancy (except localized skin cancer).
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
- San Diego , CA
- San Francisco, CA
- Atlanta, GA
- Indianapolis , IN
- Livingston, NJ
- Albany, NY
- Portland, OR
- Dallas, TX
