NCT01094327

Brief Summary

Patients with focal segmental glomerulosclerosis (FSGS) who progress rapidly to end stage renal disease (ESRD) are at highest risk for development of recurrence of proteinuria following kidney transplantation. This study will look at serum specimens pre and post transplant, as well as kidney transplant specimens pre and post reperfusion to identify where the defects has occured that results in recurrence of proteinuria in a given kidney transplant.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress97%
Feb 2008Nov 2026

Study Start

First participant enrolled

February 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
16.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

18.8 years

First QC Date

March 25, 2010

Last Update Submit

November 20, 2025

Conditions

Proteinuria

Keywords

focal segmental glomerulosclerosis

Outcome Measures

Primary Outcomes (1)

  • Explain mechanisms behind the development of proteinuria in patients immediately after receiving a kidney transplant

    chart review

    through study completion, an average of 5 years

Eligibility Criteria

AgeUp to 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric population up to the age of 25 years old, with biopsy diagnosed of FSGS (focal segmental glomerulosclerosis).

You may qualify if:

  • Kidney transplant recipients
  • Pediatric males and females up to the age of 25 years old.

You may not qualify if:

  • Transplant recipients other than kidney

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Miller School of Medicine Transplant Clinic

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

ProteinuriaGlomerulosclerosis, Focal Segmental

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGlomerulonephritisNephritisKidney Diseases

Study Officials

  • George Burke, M.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

George Burke, M.D.

CONTACT

305-355-5111gburke@med.miami.edu

Lissett Moni

CONTACT

305-243-5235ltueros@med.miami.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 26, 2010

Study Start

February 1, 2008

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)