Total Lymphoid Irradiation (TLI) to Prevent Focal Segment... | NCT00353535

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

NCT00353535

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Jul 18, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Glomerulosclerosis, Focal

Interventions

Total Lymphoid irradiation

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000

Primary Completion Date

Not provided

Completion Date

Dec 2002

First Submitted Date

Jul 17, 2006

First Submission Date that Met QC Criteria

Jul 17, 2006

First Posted Date

Jul 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2006

Last Update Posted Date

Jul 18, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Total Lymphoid irradiation	Procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Morbidity and mortality ot the treatment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo		São Paulo	São Paulo	05403-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D005923	Glomerulosclerosis, Focal Segmental
D012008	Recurrence

Ancestor Terms

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided