Neph-202

Description

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).

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.

Is there compensation for this trial? Yes

Am I Eligible or this trial?

Below is the detailed inclusion and exclusion detail for the the trial. Some of these you may know and other we may need to test in order to determine if you are a good fit for the trial. If you are not sure, please fill out the form to the left and one of our researchers will call you to assist in determining this and answering any additional questions.

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) for > 14 consecutive days or any other immunosuppression within 6 months