Obinutuzumab in Primary FSGS

  • STATUS
    Recruiting
  • End date
    Sep 16, 2024
  • participants needed
    20
  • sponsor
    Mayo Clinic
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Updated on 7 October 2022
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Summary

The purpose of this study is to evaluate the safety and efficacy of Obinutuzumab in inducing complete or partial remission of proteinuria.

Details
Condition Primary Focal Segmental Glomerulosclerosis
Treatment Obinutuzumab
Clinical Study IdentifierNCT04983888
SponsorMayo Clinic
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

≥ 18 years of age
Biopsy proven Focal Segmental Glomerulosclerosis (FSGS) lesion
Foot process effacement ≥ 80% on electron microscopy
Presence of nephrotic syndrome (proteinuria > 3.5g/24hrs and serum albumin < 3.5 g/dl) prior to initiation of immunosuppressive therapy
Resistant or dependent on therapy, including corticosteroids or calcineurin inhibitors or who have failed rituximab. Patient who have contraindication to or refuse to take high dose corticosteroids are allowed

Exclusion Criteria

Genetic or secondary forms of FSGS
Hepatitis B, C or HIV positive
Pregnant or breast-feeding
Active infection
Kidney transplant
Anemia with Hgb < 8.0 g/dL
Thrombocytopenia with platelet count < 100'000
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 complication
Patients who have received cyclophosphamide in the last 6 months
Patients who received rituximab previously with CD20 count of < 5 cells/microliter at the time of enrollment
For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug
For men: agreement to remain abstinent or use two adequate methods for contraception, including at least one method with failure rate of less than 1% per year during the treatment period and for at least 6 months (180 days) after the last dose of drug
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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