Study to Investigate the Clinical Outcomes of Different Regimens of Myfortic® in De Novo Kidney Tx Pts Using Simulect® and Neoral® With or Without Steroids

Novartis Pharmaceuticals44 sites in 13 countries342 target enrollmentMarch 2003

ConditionsKidney Transplantation

DrugsMyfortic

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Kidney Transplantation
Sponsor: Novartis Pharmaceuticals
Enrollment: 342
Locations: 44
Primary Endpoint: Calculated glomerular filtration rate after 12 months treatment
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 2003

End Date

May 2005

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Calculated glomerular filtration rate after 12 months treatment

Secondary Outcomes

Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
Patient and graft survival after 12 months.
Incidence of AEs and SAEs after 3 and 12 months.
Blood pressure, lipids and glucose profiles after 3 and 12 months.
Percentage of patients free of steroids at 12 months