Back to resultsTotal Lymphoid Irradiation (TLI) to Prevent Focal Segmental Glomerulosclerosis (FSGS)Recurrence in the Renal Graft
Primary Purpose
Glomerulosclerosis, Focal
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Total Lymphoid irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Glomerulosclerosis, Focal focused on measuring glomerulosclerosis, focal, pretransplant immunosuppression, total lymphoid irradiation, renal transplant, recurrence
Eligibility 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
Sites / Locations
- Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00353535
Brief Title
Total Lymphoid Irradiation (TLI) to Prevent Focal Segmental Glomerulosclerosis (FSGS)Recurrence in the Renal Graft
Official Title
Phase 1 Study of TLI Pretransplant to Prevent Recurrence of FSGS in the Graft
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulosclerosis, Focal
Keywords
glomerulosclerosis, focal, pretransplant immunosuppression, total lymphoid irradiation, renal transplant, recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Total Lymphoid irradiation
Primary Outcome Measure Information:
Title
Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant
Secondary Outcome Measure Information:
Title
Morbidity and mortality ot the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Chocair, Prof. PhD
Organizational Affiliation
Renal Transplant Unity - Hospital das Clinicas - Medicine School - University of Sao Paulo - Brazil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosangela Villar, MD
Organizational Affiliation
Assistent doctor and Medical Supervisor of Division of Radiotherapy - Institute of Radiology - Hospital das Clinicas - University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Total Lymphoid Irradiation (TLI) to Prevent Focal Segmental Glomerulosclerosis (FSGS)Recurrence in the Renal Graft
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