Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT01094327

Conditions

Proteinuria

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Proteinuria

Study ID

NCT01094327

Start date

Feb, 2008

Status verified date

Nov, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Transplant recipients other than kidney

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Explain mechanisms behind the development of proteinuria in patients immediately after receiving a kidney transplant [ Time Frame: through study completion, an average of 5 years ]

Central Contacts and Locations

Central contacts

George Burke, M.D.

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

Lissett Moni

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

Locations

University of Miami Miller School of Medicine Transplant Clinic

Recruiting

Miami, Florida, United States, 33136

Contacts

George Burke, M.D.

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

Principal Investigator:

George Burke, M.D.

More Information

Sponsor

University of Miami

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Keywords

  • focal segmental glomerulosclerosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-11-21.