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Clinical Trials/EUCTR2016-001042-25-Outside-EU/EEA
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

F. Hoffmann-La Roche AG0 sites720 target enrollmentOctober 3, 2016

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.

Registry
who.int
Start Date
October 3, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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