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

Phase 1 Study of TLI Pretransplant to Prevent Recurrence of FSGS in the Graft

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00353535

Enrollment

Registered

2006-07-18

Start date

2000-01-31

Completion date

2002-12-31

Last updated

2006-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glomerulosclerosis, Focal

Keywords

glomerulosclerosis, focal, pretransplant immunosuppression, total lymphoid irradiation, renal transplant, recurrence

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.

Interventions

PROCEDURETotal Lymphoid irradiation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant	—

Secondary

Measure	Time frame
Morbidity and mortality ot the treatment	—

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026