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Proteinuria in Pre and Post Transplant

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT01094327
Collaborator
(none)
100
Enrollment
1
Location
178
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study will retrospectively review patient's medical records for protein in the urine, blood creatinine and kidney biopsy results. Also character of the fluid used to flush the kidney before transplant will be analyzed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of Recipients With and Without Proteinuria, Pre and Post Kidney Transplantation
    Study Start Date :
    Feb 1, 2008
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

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

      chart review

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Kidney transplant recipients

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

    Exclusion Criteria:
    • Transplant recipients other than kidney

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miller School of Medicine Transplant Clinic Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: George Burke, M.D., University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    George W. Burke, Professor of Surgery, University of Miami
    ClinicalTrials.gov Identifier:
    NCT01094327
    Other Study ID Numbers:
    • 20070206
    First Posted:
    Mar 26, 2010
    Last Update Posted:
    Nov 11, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by George W. Burke, Professor of Surgery, University of Miami
    focal segmental glomerulosclerosis
    Additional relevant MeSH terms:
    Proteinuria

    Study Results

    No Results Posted as of Nov 11, 2021