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

Trial ID or NCT#

NCT04221477

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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 Key
Exclusion Criteria:
  1. - 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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Investigator(s)

Richard Lafayette
Richard Lafayette
Nephrologist
Professor of Medicine (Nephrology)

Contact us to find out if this trial is right for you.

Contact

Elizabeth Chen
(650) 721-3848

View on ClinicalTrials.gov