Trial information
A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).
Status: Completed
Protocol number: ML19835
Sponsor: Roche S.p.A.
Company division: Pharmaceutical
Official Scientific Title: Relationships between pharmacokinetic and pharmacodynamic strategies for assessment of the risks for acute rejection and side effects of CellCept
Brief summary: This study will provide an evaluation of the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. 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; Single Group; Pharmacokinetics/dynamics study
Condition: Kidney Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil[CellCept]
Primary outcome: 1. Correlation of pharmacokinetic (total and free MPA concentrations at 0,1 and 2 hours) to pharmacodynamic (IMPDH II activity levels and IMPDH I and II gene expression) parameters.
Key secondary outcomes: 1. Efficacy:Impact of PK, PD and pharmacogenetic parameters on clinical outcome (acute rejection, graft and patient outcome)
Safety: AEs; opportunistic infection.
Inclusion criteria:
- patients undergoing primary kidney transplantation;
- 18-65 years of age.
Exclusion criteria:
- recipients of multiple organ transplants;
- patients who have previously received CellCept;
- patients with a history of malignancies, other than successfully treated basal or squamous cell skin cancer.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 06/16/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Bari
- Brescia
- Coppito
- Napoli
- Roma
- Torino
- Verona
