Skip to main content
OpenTrials
Completed

NCT Number: NCT00101738

Freedom Study: Myfortic in Kidney Transplant Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Crai Norte, San Martín, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Myfortic

Drug

Primary outcomes

  1. Calculated glomerular filtration rate after 12 months treatment

Secondary outcomes

  1. Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.

  2. Patient and graft survival after 12 months.

  3. Incidence of AEs and SAEs after 3 and 12 months.

  4. Blood pressure, lipids and glucose profiles after 3 and 12 months.

  5. Percentage of patients free of steroids at 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jan 13, 2005
Registry last updated
Jan 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.