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

Part of paid clinical trials in Tuscaloosa, Alabama.

Sponsor
University of Minnesota
Study ID
NCT03763643
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex
ALL
Age
1 Year - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 375mg/m2 intravenous on day 0 or -1 prior to kidney transplant
  • Plasmapheresis — PROCEDURE
    1.5 volume exchange plasmapheresis with fresh frozen plasma replacement

Study Details

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.

Key Dates

Start date
Jul 1, 2019
Status verified
Sep 2025
Primary completion
Feb 7, 2025
Completion
Feb 7, 2025

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Rituximab + plasmapharesis
    This is a phase III, multicenter, randomized, open-label clinical trial. Participants with FSGS will be randomized 1:1 to receive rituximab or placebo on day -1, 0 and +1 prior to or after kidney transplantation in addition to standard plasmapheresis.
  • Placebo Comparator: Placebo + plasmapharesis
    This is a phase III, multicenter, randomized, open-label clinical trial. Participants with FSGS will be randomized 1:1 to receive rituximab or placebo on day -1, 0 and +1 prior to or after kidney transplantation in addition to standard plasmapheresis.

Primary Outcome Measure

Feasibility assessment [ Time Frame: through study completion, an average of 1 year ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of AlabamaTuscaloosaAlabama35487-
University of California at DavisDavisCalifornia95616-
Lurie Children's HospitalChicagoIllinois60611-
University of IowaIowa CityIowa52242-
Children's Hospital of ColoradoAuroraMinnesota80045-
University of MinnesotaMinneapolisMinnesota55455-
Mayo ClinicRochesterMinnesota55905-
Duke UniversityDurhamNorth Carolina27708-
Cincinnati Children's HospitalCincinnatiOhio45229-
University of CincinnatiCincinnatiOhio45221-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Tuscaloosa, AL

By research site
University of Alabama· Tuscaloosa, ALUniversity of California at Davis· Davis, CALurie Children's Hospital· Chicago, ILUniversity of Iowa· Iowa City, IAChildren's Hospital of Colorado· Aurora, MNUniversity of Minnesota· Minneapolis, MN

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