Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients

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: EUCTR2016-001042-25-Outside-EU/EEA
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-03
• Last Update Posted: 10 October 2016

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