NCT00353535

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2000

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
Last Updated

July 18, 2006

Status Verified

September 1, 2005

First QC Date

July 17, 2006

Last Update Submit

July 17, 2006

Conditions

Glomerulosclerosis, Focal

Keywords

glomerulosclerosis, focalpretransplant immunosuppressiontotal lymphoid irradiationrenal transplantrecurrence

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Morbidity and mortality ot the treatment

Interventions

Total Lymphoid irradiationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Age \< or equal 18 years
  • No biopsy-proven FSGS
  • Without living donor to perform the transplant
  • No signed the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Glomerulosclerosis, Focal SegmentalRecurrence

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 18, 2006

Study Start

January 1, 2000

Study Completion

December 1, 2002

Last Updated

July 18, 2006

Record last verified: 2005-09

Locations

BR(1)