A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

  • STATUS
    Recruiting
  • End date
    Apr 18, 2028
  • participants needed
    252
  • sponsor
    Hoffmann-La Roche
Updated on 10 July 2022
corticosteroids
prednisone
diphenhydramine
mycophenolate
mammogram
kidney biopsy
nephritis

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

Details
Condition Lupus Nephritis
Treatment prednisone, Placebo, Methylprednisolone, Obinutuzumab, MMF, Acetaminophen, Diphenhydramine
Clinical Study IdentifierNCT04221477
SponsorHoffmann-La Roche
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
Urine protein to creatinine ratio greater than or equal to (>/=) 1 on a 24-hour collection
Other inclusion criteria may apply

Exclusion Criteria

Pregnancy or breastfeeding
Severe renal impairment or the need for dialysis or renal transplantation
Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
Known active infection of any kind or recent major episode of infection
Intolerance or contraindication to study therapies
Other exclusion criteria may apply
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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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