Total Lymphoid Irradiation (TLI) to Prevent Focal Segmental Glomerulosclerosis (FSGS)Recurrence in the Renal Graft
Phase 1
Completed
- Conditions
- Glomerulosclerosis, Focal
- Registration Number
- NCT00353535
- Lead Sponsor
- University of Sao Paulo
- Brief Summary
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
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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.
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Exclusion Criteria
- Age < or equal 18 years
- No biopsy-proven FSGS
- Without living donor to perform the transplant
- No signed the informed consent
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant
- Secondary Outcome Measures
Name Time Method Morbidity and mortality ot the treatment
Trial Locations
- Locations (1)
Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo
🇧🇷Sao Paulo, Brazil