Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) (SANCTUARY)

  • STATUS
    Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    120
  • sponsor
    Alexion Pharmaceuticals
Updated on 4 October 2022
angiotensin
nephropathy
immunosuppression
proteinuria
lupus
immunoglobulin a
nephritis

Summary

The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

Description

This study consists of a 6-week Screening Period, 26-week Initial Evaluation Period, a 24-week Extension Period, and a 36-week post-treatment Follow-up Period.

Details
Condition Lupus Nephritis, Immunoglobulin A Nephropathy
Treatment Placebo, background therapy, Ravulizumab
Clinical Study IdentifierNCT04564339
SponsorAlexion Pharmaceuticals
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Common to both disease cohorts
Proteinuria ≥1 (gram [g]/day or g/g)
Vaccinated against meningococcal infection
Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements
For LN cohort
Diagnosis of active focal or diffuse proliferative LN Class III or IV
Clinically active LN, requiring/receiving immunosuppression induction treatment
For IgAN cohort
Diagnosis of primary IgAN
Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months

Exclusion Criteria

Common to both disease cohorts
eGFR < 30 milliliters/minute/1.73 meters squared
Previously received a complement inhibitor (for example, eculizumab)
Concomitant significant renal disease other than LN or IgAN
History of other solid organ or bone marrow transplant
Uncontrolled hypertension
For IgAN cohort
Diagnosis of rapid progressive glomerulonephritis
Prednisone or prednisone equivalent > 20 milligram (mg) per day for > 14 consecutive days or any other immunosuppression within 6 months
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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