RECRUITING

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

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Conditions

Lupus NephritisLupus Nephritis, anifrolumab, Systemic Lupus Erythematosus, intravenous

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

Official Title

A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

Quick Facts

Study Start:2022-02-15
Study Completion:2028-07-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05138133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
  2. 2. Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
  3. 3. Urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol)
  4. 4. eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
  5. 5. Fulfills updated 2019 EULAR/ACR SLE classification criteria.
  6. 6. No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
  1. 1. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
  2. 2. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
  3. 3. Evidence of hepatitis C or active hepatitis B.
  4. 4. Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
  5. 5. Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide \> 2 pulses of high-dose (≥ 0.5 g/m2) or \> 4 doses of low dose (500 mg every 2 weeks) or Average MMF \> 2.5 g/day (or \> 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus \> 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
  6. 6. Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
  7. 7. Known intolerance to ≤ 1.0 g/day of MMF.
  8. 8. Any history of severe COVID-19 infection.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35233
United States
Research Site
Glendale, Arizona, 85306
United States
Research Site
La Jolla, California, 92037
United States
Research Site
La Palma, California, 90623
United States
Research Site
Loma Linda, California, 92354
United States
Research Site
Los Angeles, California, 90095
United States
Research Site
Orange, California, 92868
United States
Research Site
Upland, California, 91786
United States
Research Site
New Haven, Connecticut, 06519
United States
Research Site
Newark, Delaware, 19713
United States
Research Site
Hallandale Beach, Florida, 33009
United States
Research Site
Plantation, Florida, 33324
United States
Research Site
Sun City Center, Florida, 33573
United States
Research Site
Atlanta, Georgia, 30308
United States
Research Site
Louisville, Kentucky, 40202
United States
Research Site
Saint Louis, Missouri, 63108
United States
Research Site
Las Vegas, Nevada, 89128
United States
Research Site
Newark, New Jersey, 07103
United States
Research Site
Summit, New Jersey, 07901
United States
Research Site
Las Cruces, New Mexico, 88011
United States
Research Site
Great Neck, New York, 11021
United States
Research Site
Manhasset, New York, 11030
United States
Research Site
New York, New York, 10016
United States
Research Site
New York, New York, 10032
United States
Research Site
Winston-Salem, North Carolina, 27157
United States
Research Site
Middleburg Heights, Ohio, 44130
United States
Research Site
Danville, Pennsylvania, 17822
United States
Research Site
Allen, Texas, 75013
United States
Research Site
Colleyville, Texas, 76034
United States
Research Site
Edinburg, Texas, 78539
United States
Research Site
El Paso, Texas, 79902
United States
Research Site
Houston, Texas, 77054
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-15
Study Completion Date2028-07-07

Study Record Updates

Study Start Date2022-02-15
Study Completion Date2028-07-07

Terms related to this study

Keywords Provided by Researchers

  • Lupus Nephritis, anifrolumab, Systemic Lupus Erythematosus, intravenous

Additional Relevant MeSH Terms

  • Lupus Nephritis