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NCT04088799 · ClinicalTrials.gov registry record
LDL-Apheresis for FSGS CardioRenal Outcomes
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 10
- Enrollment target
NCT04088799: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04088799 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04088799 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
Focal segmental glomerulosclerosis (FSGS) is the most common cause of end-stage renal disease (ESRD) in adolescents. The refractory nature of FSGS and a more than 30% recurrence rate after kidney transplantation renders treatment of FSGS one of the most difficult challenges in pediatric nephrology. A significant knowledge gap in understanding the mechanism of FSGS treatment resistance and progression hampers development of successful treatment strategies. Beneficial effect of removal of low-density lipoproteins by LDL-apheresis indicates that lipids contribute to progression in FSGS. The investigators will test the hypothesis that removal of Lp-PLA2 and lipid metabolites by LDL-apheresis ameliorates proteinuria and cardiovascular comorbidities. Patients with FSGS and FSGS recurrence after kidney transplantation receiving LDL-apheresis as part of standard of care will be enrolled to the study. Pre-and post serum and effluent concentrations of LPC, free FA, Lp-PLA2, oxidized LDL, fasting lipid profile, interleukin (IL)-6, tumor necrosis factor (TNF)-α, and IL-1β will be monitored in patients undergoing LDL-apheresis. Investigators will also study the impact of LDL-apheresis on cardiovascular and clinical comorbidities by monitoring degree of proteinuria, blood pressures and arterial stiffness index.
Primary Outcome
Standard of care proteinuria will be monitored for expected improvement in severity
Interventions
- OTHER No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2023-06-01 |
What the finished NCT04088799 record still lists
NCT04088799 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.
NCT04088799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04088799 about?
NCT04088799 is a clinical study titled "LDL-Apheresis for FSGS CardioRenal Outcomes". Focal segmental glomerulosclerosis (FSGS) is the most common cause of end-stage renal disease (ESRD) in adolescents. The refractory nature of FSGS and a more than 30% recurrence rate after kidney transplantation renders treatment of FSGS one of the most difficult challenges in pediatric nephrology. ...
What is the current status of trial NCT04088799?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2019-01-01. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT04088799?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT04088799?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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