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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00353535
First Posted: July 18, 2006
Last Update Posted: July 18, 2006
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.
Information provided by:
University of Sao Paulo
  Purpose
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: None (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00353535


Locations
Brazil
Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo
Sao Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
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

ClinicalTrials.gov Identifier: NCT00353535     History of Changes
Other Study ID Numbers: TLIFSGSusp
First Submitted: July 17, 2006
First Posted: July 18, 2006
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
recurrence

Additional relevant MeSH terms:
Recurrence
Glomerulosclerosis, Focal Segmental
Disease Attributes
Pathologic Processes
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases