Status:
COMPLETED
LDL-Apheresis for FSGS CardioRenal Outcomes
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Kaneka Medical America LLC
Conditions:
Focal Segmental Glomerulosclerosis
Eligibility:
All Genders
Up to 21 years
Brief 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 tran...
Detailed Description
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 tran...
Eligibility Criteria
Inclusion
- FSGS and a glomerular filtration rate (GFR) ≥ 60 ml/min/1.73m2 AND
- Refractory nephrotic syndrome in which standard treatment options are unsuccessful (i.e., patient is unresponsive to standard corticosteroid and/or calcineurin inhibitor therapy for at least 8 weeks resulting in failure to achieve complete or partial remission), OR
- Refractory nephrotic syndrome in which standard treatment options are not well tolerated (i.e., patients intolerant to standard therapies due to severe side effects without providing an acceptable level of clinical benefit), OR
- Refractory or recurrent nephrotic syndrome in which standard therapy is contraindicated
- Post renal transplant with nephrotic syndrome associated with primary FSGS
Exclusion
- Greater than 21 years of age
- Parent or patient unwilling or unable to signed and date the informed consent
- Pregnant, lactating, or planning to become pregnant prior to completing the study
- Unable or unwilling to comply with the follow-up schedule
- Simultaneously participating in another investigational drug or device study (except for LDL-apheresis associated trials)
- Body weight less than 21 kilograms (46 pounds)
- Currently being administered angiotensin converting enzyme (ACE) inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment
- Currently being administered antihypertensive drugs other than ACE inhibitors than cannot be withheld on the day of LDL-apheresis until after the procedure
- Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis
- Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
- Inability to achieve adequate anticoagulation
- Inability to tolerate extracorporeal circulation therapy with Liposorber® LA-15
- Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease
- Thyroid disease or liver abnormalities
- Unresolved systemic or local infection that could affect the clinical study outcomes
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04088799
Start Date
January 1 2019
End Date
June 1 2023
Last Update
December 21 2023
Active Locations (2)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
2
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224