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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

Must not have

Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.)

Concomitant malignancies or previous malignancies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 1 year post-transplant

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My FSGS is caused by another condition like obesity or an infection.

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I have or had another type of cancer.

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My FSGS is caused by a genetic condition.

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I am not pregnant, breastfeeding, and I agree to use birth control.

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I have a history of serious heart or lung disease.

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I do not have any current serious infections or recent major infections requiring strong antibiotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 1 year post-transplant

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility assessment

Secondary study objectives

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Plasmapheresis

2016

Completed Phase 3