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A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis
Overall Recruitment Status: Active, currently enrolling
 
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)
 
Region Sponsors
California - Northern
Roche Bioscience
 
Acronym KP IRB No.
1562150
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with Diagnosis of Lupus Nephritis
 
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
 
Gender Age Limit
Male & Female 18 - 75 years
 
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
  • Hormones, Hormone Substitutes, and Hormone Antagonists
  • Analgesics
  • Immune System Diseases
  • Analgesics, Non-Narcotic
  • Kidney Diseases
  • Antiemetics
  • Lupus Erythematosus, Systemic
  • Anti-Inflammatory Agents
  • Lupus Nephritis
  • Antineoplastic Agents
  • Methylprednisolone
  • Antineoplastic Agents, Hormonal
  • Nephritis
  • Antipyretics
  • Obinutuzumab
  • Autoimmune Diseases
  • Peripheral Nervous System Agents
  • Autonomic Agents
  • Physiological Effects of Drugs
  • Connective Tissue Diseases
  • Prednisone
  • Diphenhydramine
  • Promethazine
  • Glomerulonephritis
  • Sensory System Agents
  • Glucocorticoids
  • Urologic Diseases
  • Hormones
  • Nephrology
 
KP Clinical Facility
  • Central Valley-Stockton
  • Fremont Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Richmond Medical Center
  • Roseville Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Teresa Medical Center-San Jose
  • Vallejo Medical Center
 
Clinical Area
  • Nephrology


Principal Investigator:
Ali X Poyan Mehr, MD
Contact Information:
- Nephrology KPNC
-415-833-3485
-catherine.vowels@kp.org
-San Francisco Medical Center


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