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

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 I

MedlinePlus related topics:

Kidney Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Phase 1 Study of TLI Pretransplant to Prevent Recurrence of FSGS in the Graft

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

Study ID Numbers:	TLIFSGSusp
First Received:	July 17, 2006
Last Updated:	July 17, 2006
ClinicalTrials.gov Identifier:	NCT00353535
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

Study placed in the following topic categories:

Glomerulosclerosis, Focal Segmental

Glomerulonephritis

Urologic Diseases

Nephritis

Kidney Diseases

Recurrence

Focal segmental glomerulosclerosis

Additional relevant MeSH terms:

Disease Attributes

Pathologic Processes

ClinicalTrials.gov processed this record on November 03, 2008

Sponsored by:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00353535