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Monoclonal Antibodies

Plasmapheresis + Rituximab for FSGS

Phase < 1
Recruiting
Led By Michelle Rheault, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of nephrotic syndrome (proteinuria, edema, hypoalbuminemia)
Biopsy proven diagnosis of primary FSGS or minimal change disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 1 year post-transplant
Awards & highlights

Study Summary

This trial is testing whether a treatment of plasmapheresis plus rituximab can prevent recurrent FSGS in children and adults who have undergone a kidney transplant.

Who is the study for?
This trial is for children and adults aged 1-65 with a confirmed diagnosis of primary FSGS or minimal change disease, who are undergoing their first to third kidney transplant. Participants must not have genetic causes of FSGS, known allergies to rituximab or murine proteins, active infections, recent drug abuse, significant heart or lung disease, other trials within the last 30 days or certain blood disorders.Check my eligibility
What is being tested?
The PRI-VENT FSGS trial is testing if plasmapheresis combined with rituximab before or at the time of kidney transplantation can prevent recurrent FSGS. It's an open label study where participants will be randomly assigned to receive these interventions around the time they get their new kidney.See study design
What are the potential side effects?
Rituximab may cause infusion reactions like fever and chills; skin rashes; possible organ inflammation; and could lower resistance to infections. Plasmapheresis might lead to low blood pressure, light-headedness, bleeding from anticoagulants used during the procedure, muscle cramps and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had nephrotic syndrome.
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I have been diagnosed with FSGS or minimal change disease through a biopsy.
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I am between 1 and 65 years old and need a kidney transplant.
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I am getting my first, second, or third kidney transplant due to FSGS recurrence.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 1 year post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 1 year post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility assessment
Secondary outcome measures
Graft function at 1 year post-transplant
Patient and graft survival at 1 year post-transplant
Proportion with CD19+ <1%
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rituximab + plasmapharesisExperimental Treatment2 Interventions
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.
Group II: Placebo + plasmapharesisPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Plasmapheresis
2016
Completed Phase 3
~390

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
865 Previous Clinical Trials
327,639 Total Patients Enrolled
University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,715 Total Patients Enrolled
Michelle Rheault, MDPrincipal InvestigatorUniversity of Minnesota

Media Library

Rituximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03763643 — Phase < 1
Focal Segmental Glomerulosclerosis Research Study Groups: Placebo + plasmapharesis, Rituximab + plasmapharesis
Focal Segmental Glomerulosclerosis Clinical Trial 2023: Rituximab Highlights & Side Effects. Trial Name: NCT03763643 — Phase < 1
Rituximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03763643 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially be enrolled in this medical study?

"Applicants for this clinical trial must have hyalinosis, segmental glomerular and be between 1 year old and 65. Around 60 candidates are needed to complete the study."

Answered by AI

How many individuals are being surveyed for this experiment?

"This medical investigation requires the participation of 60 appropriate individuals. Cincinnati Children's Hospital in Ohio and University of Iowa in Iowa City, Iowa are two examples of locations where interested parties may enroll."

Answered by AI

Does this trial include participants of thirty or more years in age?

"Patients must be between 1 and 65 years of age to participate in this investigation. For younger participants, there are 61 trials available; those aged 65 or older have 384 studies open to them."

Answered by AI

What other empirical investigations have been done concerning Plasmapheresis?

"The practice of plasmapheresis was first reported in the year 1993, at the NIH Clinical Center located at 9000 Rockville Pike. Since then, 19123 trials have been completed while 405 are still ongoing; a majority of these active studies can be found in Cincinnati, Ohio."

Answered by AI

What diseases or conditions often necessitate Plasmapheresis?

"Plasmapheresis offers a therapeutic option for diffuse large b-cell lymphoma (dlbcl) and other maladies such as B-cell lymphomas, polyangiitis, and pemphigus vulgaris."

Answered by AI

Are additional participants still being taken on for this experiment?

"The details at clinicaltrials.gov reveals that this research is still in the recruitment phase, having been initially posted on July 1st 2019 and most recently amended on October 19th 2022."

Answered by AI

What is the prevalence of locations running this trial in state?

"Right now, the trial is available at 14 sites, including Cincinnati, Iowa City and Aurora. To ease any strain on participants from travelling too far for their treatments, it is advised to select a site that is near your current residence."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant
2019. "PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03763643.
~13 spots leftby Aug 2025
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