ESTEROID WITHDRAWAL STUDY, SAFETY AND EFFICACY IN RENAL TRANPLANTATION

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

BACKGROUND: Non-steroid maintenance immunosuppression after transplantation can improve long-term lipid and hemodynamic profiles without severe acute rejection (AR) events that alter graft function or survival. Our objective was to evaluate the effects of early steroid withdrawal (ESW) on the frequency and severity of AR using an immunosuppressive scheme consisting of mycophenolate (MMF) and tacrolimus (TAC) in combination with an induction treatment with basiliximab.

METHODS: A randomized clinical trial was performed on first renal transplant recipients. In the ESW group, patients were selected for corticosteroid treatment withdrawal on the fifth day post-transplantation. In the Control group, patients continued steroid treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Unidad de Investigacion Medica en Enfermedades Renales
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• Over 18 years of age

• Panel reactive antibody (PRA) class I and II HLA <20%.

• Any gender

• Living donor

Exclusion Criteria:

• Patients with co-morbidities that required the use of steroid,

• Delayed graft function or AR during the 5 days post-transplantation,

• Along with patients that decided to leave the study.

• Multiorganic recipients