Proteinuria in Pre and Post Transplant | NCT01094327

Studies
Proteinuria in Pre and Post Transplant

NCT01094327

Sponsor

University of Miami

Status

Recruiting

Last Update Posted

Nov 21, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Proteinuria

Interventions

Not provided

Countries

United States

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

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008Actual

Primary Completion Date

Nov 30, 2026Estimated

Completion Date

Nov 30, 2026Estimated

First Submitted Date

Mar 25, 2010

First Submission Date that Met QC Criteria

Mar 25, 2010

First Posted Date

Mar 26, 2010Estimated

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

Nov 20, 2025

Last Update Posted Date

Nov 21, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Transplant recipients other than kidney

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
George Burke, M.D.	Contact	305-355-5111		gburke@med.miami.edu
Lissett Moni	Contact	305-243-5235		ltueros@med.miami.edu

Overall Officials

Name	Affiliation	Role
George Burke, M.D.	University of Miami	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami Miller School of Medicine Transplant Clinic	Recruiting	Miami	Florida	33136	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011507	Proteinuria
D005923	Glomerulosclerosis, Focal Segmental

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided