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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03763643
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
This is a phase III, multicenter, randomized, open label, clinical trial to test that hypothesis that plasmapheresis plus rituximab prior to kidney transplantation can prevent recurrent FSGS in children and adults.

Condition or disease Intervention/treatment Phase
Focal Segmental Glomerulosclerosis Drug: Rituximab Drug: Placebo Procedure: Plasmapheresis Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Control group and treatment/intervention group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
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 0 or -1 prior to kidney transplantation in addition to standard plasmapheresis.
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

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 0 or -1 prior to kidney transplantation in addition to standard plasmapheresis.
Drug: Placebo
1.5 volume exchange plasmapheresis with fresh frozen plasma replacement

Procedure: Plasmapheresis
1.5 volume exchange plasmapheresis with fresh frozen plasma replacement




Primary Outcome Measures :
  1. Recurrent FSGS at 1 year post-transplant. [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. AE and SAE Reporting [ Time Frame: through study completion, an average of 1 year ]
    To ensure treatment is safe

  2. Patient and graft survival at 1 year post-transplant [ Time Frame: through study completion, an average of 1 year ]
    survival

  3. Graft function at 1 year post-transplant (eGFR by bedside Schwartz equation for age ≤17 years and CKD-EPI for age ≥18 years) [ Time Frame: through study completion, an average of 1 year ]
  4. Proportion with acute rejection at 1 year post-transplant [ Time Frame: through study completion, an average of 1 year ]
  5. Proportion with CD19+ <1% at 1 month, 6 months, and 12 months [ Time Frame: through study completion, an average of 1 year ]
  6. Recurrent FSGS free survival [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Age 1-40 years at the time of kidney transplant
  2. Biopsy proven diagnosis of primary FSGS or minimal change disease
  3. History of nephrotic syndrome (proteinuria, edema, hypoalbuminemia)
  4. First kidney transplant or second kidney transplant with a history of recurrent FSGS in the first transplant
  5. The patient (if ≥18 years old) or the child's parent or guardian must be able and willing to give written informed consent and comply with the requirements of the study protocol. Patient assent if <18 years old will be required per local IRB requirements.
  6. Negative urine pregnancy test prior to randomization (for females who are post-menarche).
  7. Males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment with rituximab.

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Known genetic cause of FSGS 2. Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.) 3. 4. Received rituximab within 1 year prior to transplant 5. Known hypersensitivity to rituximab, to any of its excipients, or to murine proteins 6. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies 7. Known active bacterial, viral (e.g. HIV, hepatitis B, hepatitis C), fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening visit.

8. Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug (whichever is longer) 9. ANC < 1.5 x 103 10. Hemoglobin: < 8.0 gm/dL 11. Platelets: < 100,000/mm 12. AST or ALT >2.5 x Upper Limit of Normal at the local institution's laboratory 13. History of drug, alcohol, or chemical abuse within 6 months prior to screening visit.

14. Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential 15. Concomitant malignancies or previous malignancies 16. History of psychiatric disorder that would interfere with normal participation in this protocol 17. History of significant cardiac (including arrhythmias) or pulmonary disease (including obstructive pulmonary disease) 18. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications 19. Inability to comply with study and follow-up procedures


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763643


Contacts
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Contact: Thu Danh, MPH 6126247674 danhx005@umn.edu
Contact: Kelly McCormick 6126243315 kmmccorm@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Michelle Rheault    612-626-2922    rheau002@umn.edu   
Sponsors and Collaborators
University of Minnesota
United States Department of Defense
Investigators
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Principal Investigator: Michelle Rheault, MD University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03763643    
Other Study ID Numbers: STUDY00004388
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents