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

July 17, 2006 updated by: University of Sao Paulo

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant

Secondary Outcome Measures

Outcome Measure
Morbidity and mortality ot the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

July 17, 2006

First Submitted That Met QC Criteria

July 17, 2006

First Posted (Estimate)

July 18, 2006

Study Record Updates

Last Update Posted (Estimate)

July 18, 2006

Last Update Submitted That Met QC Criteria

July 17, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLIFSGSusp

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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