We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00353535
Recruitment Status : Completed
First Posted : July 18, 2006
Last Update Posted : July 18, 2006
Information provided by:
University of Sao Paulo

July 17, 2006
July 18, 2006
July 18, 2006
January 2000
Not Provided
Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant
Same as current
No Changes Posted
Morbidity and mortality ot the treatment
Same as current
Not Provided
Not Provided
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
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
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.
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glomerulosclerosis, Focal
Procedure: Total Lymphoid irradiation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2002
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
University of Sao Paulo
Not Provided
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
University of Sao Paulo
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP