Active, currently enrolling

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)

NCT No.: NCT04221477

Study Type: INTERVENTIONAL

Phase: Phase III

Region: California - Northern

Acronym: 

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)

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.

Detailed Description

Sex

Male & Female

Age Limit

18 - 75 years

Eligibility Criteria

Inclusion Criteria

  • 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

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

Keywords and/or Specific Medical Conditions

  • Acetaminophen
  • Analgesics
  • Analgesics, Non-Narcotic
  • Antiemetics
  • Anti-Inflammatory Agents
  • Antineoplastic Agents
  • Antineoplastic Agents, Hormonal
  • Antipyretics
  • Autoimmune Diseases
  • Autonomic Agents
  • CA41705
  • Connective Tissue Diseases
  • Diphenhydramine
  • Glomerulonephritis
  • Glucocorticoids
  • Hormones
  • Hormones, Hormone Substitutes, and Hormone Antagonists
  • Immune System Diseases
  • Kidney Diseases
  • Lupus Erythematosus, Systemic
  • Lupus Nephritis
  • Methylprednisolone
  • Nephritis
  • Obinutuzumab
  • Peripheral Nervous System Agents
  • Physiological Effects of Drugs
  • Prednisone
  • Promethazine
  • Sensory System Agents
  • Urologic Diseases
  • Nephrology

Sponsors

  • Roche Bioscience

KP Clinical Facility

Clinical Area

  • Nephrology

Principal Investigator

Ali X Poyan Mehr , MD 

Contact Information

 - CTP Collaborate Team
- CTPCollaborate@kp.org
- San Francisco Medical Center

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