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CompletedNCT00353535Updated Jul 18, 2006

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

A Phase 1 interventional study of Total Lymphoid irradiation in Glomerulosclerosis, Focal, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-07-18.

Sponsored by University of Sao Paulo · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Glomerulosclerosis, Focal

Keywords

  • glomerulosclerosis, focal
  • pretransplant immunosuppression
  • total lymphoid irradiation
  • renal transplant
  • recurrence
03

In context

Glomerulosclerosis, Focal Segmental

98 studies on the registry are indexed under Glomerulosclerosis, Focal Segmental; 31 are open to participants now.

This study's enrollment of 10 is below the median of 32 across 69 interventional studies indexed under Glomerulosclerosis, Focal Segmental.

Browse Glomerulosclerosis, Focal Segmental studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Age \< or equal 18 years
  • No biopsy-proven FSGS
  • Without living donor to perform the transplant
  • No signed the informed consent
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants

Interventions

  • ProcedureTotal Lymphoid irradiation
06

What researchers measure

Primary outcomes

  1. Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant

Secondary outcomes

  1. Morbidity and mortality ot the treatment

07

Study locations

1 site
  • Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo
    Sao Paulo, 05403-000, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00353535
Lead sponsor
University of Sao Paulo
First posted
Jul 18, 2006
Start date
Jan 2000
Completion
Dec 2002
Last update
Jul 18, 2006

Study contacts

Pedro Chocair, Prof. PhD
principal investigator · Renal Transplant Unity - Hospital das Clinicas - Medicine School - University of Sao Paulo - Brazil
Rosangela Villar, MD
principal investigator · Assistent doctor and Medical Supervisor of Division of Radiotherapy - Institute of Radiology - Hospital das Clinicas - University of Sao Paulo
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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