Total Lymphoid Irradiation (TLI) to Prevent Focal Segmental Glomerulosclerosis (FSGS)Recurrence in the Renal Graft

University of Sao Paulo

Status and phase: Completed; Phase 1

Conditions: Glomerulosclerosis, Focal

Treatments: Procedure: Total Lymphoid irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT00353535

TLIFSGSusp

Details and patient eligibility

About

The purpose was study the immunosuppression using total lymphoid irradiation plus Csa, MMF and prednisone pretransplant to prevent focal segmental glomerulosclerosis recurrence in the renal graft

Full description

Focal and segmental glomerulosclerosis (FSGS) is resistant to treatment with immunosuppressants and after transplant, 40% of such patients have recurrences in renal allograft. The purpose of this trial was to use Total Lymphoid Irradiation (TLI) plus mycophenolate mofetil (MMF), cyclosporine A (CsA) and prednisone (PRED) to prevent recurrence.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients (age > 18 years)
• Biopsy-proven primary FSGS
• End-stage renal failure at presentation or prior allograft loss due to recurrent FSGS.
• Signed the informed consent before entering in the study.

Exclusion criteria

• Age < or equal 18 years
• No biopsy-proven FSGS
• Without living donor to perform the transplant
• No signed the informed consent

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)