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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00353535
Recruitment Status : Completed
First Posted : July 18, 2006
Last Update Posted : July 18, 2006
Information provided by:
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

Condition or disease Intervention/treatment Phase
Glomerulosclerosis, Focal Procedure: Total Lymphoid irradiation Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of TLI Pretransplant to Prevent Recurrence of FSGS in the Graft
Study Start Date : January 2000
Study Completion Date : December 2002

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

Secondary Outcome Measures :
  1. Morbidity and mortality ot the treatment

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00353535     History of Changes
Other Study ID Numbers: TLIFSGSusp
First Posted: July 18, 2006    Key Record Dates
Last Update Posted: July 18, 2006
Last Verified: September 2005

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