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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:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00353535
First received: July 17, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00353535     History of Changes
Other Study ID Numbers: TLIFSGSusp
Study First Received: July 17, 2006
Last Updated: July 17, 2006
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on May 23, 2013