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

This study has been completed.
Information provided by:
University of Sao Paulo Identifier:
First received: July 17, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted
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

Condition Intervention Phase
Glomerulosclerosis, Focal Procedure: Total Lymphoid irradiation Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of TLI Pretransplant to Prevent Recurrence of FSGS in the Graft

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant

Secondary Outcome Measures:
  • Morbidity and mortality ot the treatment

Estimated Enrollment: 10
Study Start Date: January 2000
Estimated Study Completion Date: December 2002
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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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Please refer to this study by its identifier: NCT00353535

Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo
Sao Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Principal Investigator: Pedro Chocair, Prof. PhD Renal Transplant Unity - Hospital das Clinicas - Medicine School - University of Sao Paulo - Brazil
Principal Investigator: Rosangela Villar, MD Assistent doctor and Medical Supervisor of Division of Radiotherapy - Institute of Radiology - Hospital das Clinicas - University of Sao Paulo
  More Information Identifier: NCT00353535     History of Changes
Other Study ID Numbers: TLIFSGSusp
Study First Received: July 17, 2006
Last Updated: July 17, 2006

Keywords provided by University of Sao Paulo:
glomerulosclerosis, focal
pretransplant immunosuppression
total lymphoid irradiation
renal transplant

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases processed this record on July 19, 2017