LIPOSORBER® LA-15 for Focal Segmental Glomerulosclerosis

Loma Linda University Hospital, Loma Linda, CA
Focal Segmental GlomerulosclerosisLIPOSORBER® LA-15 - Device
Eligibility
No minimum age - 75
All Sexes

Study Summary

This trial will study whether the LIPOSORBER® LA-15 System is an effective and safe treatment for patients with nephrotic syndrome associated with FSGS who have failed or not well tolerated standard treatments.

Eligible Conditions
  • Focal Segmental Glomerulosclerosis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1 month after the final Apheresis treatment.

Month 1
Evaluate the safety and probable benefit of the LIPOSORBER® LA-15 System in relieving nephrotic syndrome associated with primary FSGS at 1 month after the final apheresis treatment. partial remission at 1 month after the final apheresis treatment.
Month 24
Nephrotic condition at 1, 3, 6, 12, and 24 months after the final apheresis treatment, including the percentage of patients who obtain complete or partial remission at 3, 6, 12, and 24 months.

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

LIPOSORBER® LA-15 System
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: LIPOSORBER® LA-15 · No Placebo Group · N/A

LIPOSORBER® LA-15 System
Device
Experimental Group · 1 Intervention: LIPOSORBER® LA-15 · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month after the final apheresis treatment.

Who is running the clinical trial?

Kaneka Medical America LLCLead Sponsor
11 Previous Clinical Trials
669 Total Patients Enrolled

Eligibility Criteria

Age No minimum age - 75 · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

How many physical sites are conducting this investigation?

"This investigation is actively being conducted in 10 different sites, including Chapel Hill, Akron and Wilmington. To limit any necessary journeying for enrolment, participants should carefully select the trials nearest to them." - Anonymous Online Contributor

Unverified Answer

How many people have enrolled in this research project?

"Absolutely. Clinicaltrials.gov indicates that this research trial, which was first uploaded on January 1st 2020, is actively looking to enrol participants. 35 people are needed from 10 different sites." - Anonymous Online Contributor

Unverified Answer

Does this research have any age restrictions?

"In accordance with the eligibility criteria, children under 0 and adults up to 75 years old may participate in this clinical research." - Anonymous Online Contributor

Unverified Answer

Are there any openings in this clinical research study?

"That is accurate. According to the data on clinicaltrials.gov, this experiment was first advertised in January 2020 and has been actively seeking participants since then with a most recent update occurring at the end of March 2021. The trial requires 35 volunteers from 10 medical sites." - Anonymous Online Contributor

Unverified Answer

What prerequisites must be met in order to become a participant of this medical experiment?

"The trial seeks 35 hyalinosis, segmental glomerular patients aged between 0-75. To be eligible for the study, individuals must have either failed to respond or experienced adverse effects from corticosteroid and/or calcineurin inhibitors treatments with a GFR ≥45 ml/min/1.73 m2., or they should already had undergone renal transplantation." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.