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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2002-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Glomerulosclerosis, Focal

Keywords

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glomerulosclerosis, focal pretransplant immunosuppression total lymphoid irradiation renal transplant recurrence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Total Lymphoid irradiation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Pedro Chocair, Prof. PhD

Role: PRINCIPAL_INVESTIGATOR

Renal Transplant Unity - Hospital das Clinicas - Medicine School - University of Sao Paulo - Brazil

Rosangela Villar, MD

Role: PRINCIPAL_INVESTIGATOR

Assistent doctor and Medical Supervisor of Division of Radiotherapy - Institute of Radiology - Hospital das Clinicas - University of Sao Paulo

Locations

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Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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TLIFSGSusp

Identifier Type: -

Identifier Source: org_study_id