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Freedom Study: Myfortic in Kidney Transplant Patients

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Novartis

Status and phase

Completed
Phase 3

Conditions

Kidney Transplantation

Treatments

Drug: Myfortic

Study type

Interventional

Funder types

Industry

Identifiers

NCT00101738
CERL080A2404

Details and patient eligibility

About

The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.

Enrollment

342 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males and females aged 18 to 75 years.
  • Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression.

Exclusion criteria

  • Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
  • Kidneys from non-heart beating donors or HLA identical living related donors.
  • ABO incompatibility against the donor.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

44

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Data sourced from clinicaltrials.gov

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