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PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant

NCT03763643 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-09-10

No results posted yet for this study

Summary

This is a pilot/feasibility, multicenter, randomized, open label, clinical trial to test that hypothesis that plasmapheresis plus rituximab prior to or at the time of kidney transplantation can prevent recurrent FSGS in children and adults.

Conditions

  • Focal Segmental Glomerulosclerosis

Interventions

DRUG

Rituximab

Rituximab 375mg/m2 intravenous on day 0 or -1 prior to kidney transplant

PROCEDURE

Plasmapheresis

1.5 volume exchange plasmapheresis with fresh frozen plasma replacement

Sponsors & Collaborators

Principal Investigators

  • Michelle Rheault, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2025-02-07
Completion
2025-02-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03763643 on ClinicalTrials.gov