ProteinuriaNCT01094327
Proteinuria in Pre and Post Transplant
An observational study of Proteinuria, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Proteinuria
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric population up to the age of 25 years old, with biopsy diagnosed of FSGS (focal segmental glomerulosclerosis).
Who may be able to join
- Kidney transplant recipients
- Pediatric males and females up to the age of 25 years old.
Who cannot join
- Transplant recipients other than kidney
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami Miller School of Medicine Transplant Clinic
Miami, Florida, 33136
George Burke, M.D., 305-355-5111, gburke@med.miami.edu
George Burke, M.D.
About this study
Official title: Evaluation of Recipients With and Without Proteinuria, Pre and Post Kidney Transplantation
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.
Read the 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.
- Conditions
- Proteinuria
- Keywords
- focal segmental glomerulosclerosis
- Medical subject headings
- Proteinuria, Glomerulosclerosis, Focal Segmental
What is being measured
The primary outcome is the main question the study is designed to answer.
Explain mechanisms behind the development of proteinuria in patients immediately after receiving a kidney transplant
chart review
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startFeb 2008
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George W. Burke, University of Miami
- Investigators
- George Burke, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094327
- Sponsor's protocol ID
- 20070206
- Status last verified
- Nov 2025
- First submitted
- 25 Mar 2010
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Recipients With and Without Proteinuria, Pre and Post Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01094327
- Acronym / sponsor ID
- 20070206
- Conditions
- Proteinuria
- Keywords
- focal segmental glomerulosclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Feb 2008 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric population up to the age of 25 years old, with biopsy diagnosed of FSGS (focal segmental glomerulosclerosis).
Key inclusion criteria (2 listed)
- Kidney transplant recipients
- Pediatric males and females up to the age of 25 years old.
Key exclusion criteria (1 listed)
- Transplant recipients other than kidney
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
chart review
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Enrolling by invitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George Burke, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proteinuria, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George Burke, M.D. (305-355-5111, gburke@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.