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

Phase 1

Conditions: Renal Transplantation
MedDRA version: 19.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2016-001043-39-Outside-EU/EEA

Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 720

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 650
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare the efficacy and the effects on renal function of a regimen of<br>reduced concentration of calcineurin inhibitor (cyclosporine or tacrolimus) and monitored CellCept to regimen of standard concentrations of calcineurin inhibitor and fixed dose CellCept.;Secondary Objective: Compare the safety and efficacy of a regimen of therapeutic drug monitored CellCept and full concentration of calcineurin inhibitor (CNI) to 1) fixed dose CellCept and full concentration of CNI and to 2) therapeutic drug monitored CellCept and reduced CNI.;Primary end point(s): -Percentage of patients experiencing treatment failure <br>-Renal allograft function calculated by glomerular filtration rate (GFR assessed by the Nankivell equation);Timepoint(s) of evaluation of this end point: 12 months post randomization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Proportion of patients experiencing treatment failure<br>- Proportion of patients experiencing biopsy proven acute rejection<br>- Total number of biopsy proven acute rejection episodes per patient<br>- Proportion of patients treated for acute rejection<br>- Proportion of patient deaths<br>- Proportion of patients with graft loss<br>- Proportion of patients who discontinue CellCept therapy<br>- Time to first biopsy proven acute rejection<br>- Time to treatment failure<br>- Area under the concentration versus time curve (AUC) for MPA acid exposure<br>- Trough (pre dose) concentrations<br>- Abbreviated AUC measurements<br>- Proportion of patients with adverse events<br>- Proportion of patients with opportunistic infections<br>- Proportion of patients with malignancies<br>- Proportion of patients with abnormal laboratory findings<br>- Renal function assessed by calculated GFR;Timepoint(s) of evaluation of this end point: 3, 6, 12 and 24 months post transplantation