EUCTR2016-001042-25-Outside-EU/EEA
Active, not recruiting
Phase 1
A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation
ConditionsRenal TransplantationMedDRA version: 19.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865Therapeutic area: Body processes [G] - Immune system processes [G12]
DrugsCellCept
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Renal Transplantation
- Sponsor
- F. Hoffmann-La Roche AG
- Enrollment
- 720
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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