Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

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)

Keywords

Lupus Nephritis Nephritis Acetaminophen Diphenhydramine Promethazine Prednisone Methylprednisolone Obinutuzumab MMF

Eligibility

You can join if…

Open to people ages 18-75

  • Diagnosis of ISN/RPS 2003 Class III or IV 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92093 United States
  • Kaiser Permanente - Fontana not yet accepting patients
    Fontana California 92335 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04221477
Phase
Phase 3
Study Type
Interventional
Last Updated