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

Glomerulosclerosis, Focal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353535
• Other study ID #: TLIFSGSusp
• Status: Completed
• Phase: Phase 1
• First received: July 17, 2006
• Last updated: July 17, 2006
• Start date: January 2000
• Est. completion date: December 2002

Study information

• Verified date: September 2005
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulosclerosis, Focal
• Glomerulosclerosis, Focal Segmental
• Recurrence

Intervention

Procedure:
• Total Lymphoid irradiation

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant
Secondary	Morbidity and mortality ot the treatment