In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is: • How much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body. The study will be done as follows: * Participants will be screened to check if they can join the study. * Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. * Neither the researchers nor the participants will know what the participants will receive. * Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks. * Afterwards, participants will enter a follow-up period which will last 80 weeks. * In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.
The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on proteinuria in participants with Immunoglobulin A nephropathy (IgAN). The main secondary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on kidney functions in participants with IgAN. The additional secondary objectives are to evaluate the efficacy of felzartamab compared to placebo on additional clinical endpoints and to assess the pharmacokinetics (PK) and immunogenicity of felzartamab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
454
Administered IV
Administered IV
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
RECRUITINGKidney & Hypertension Center - Apple Valley
Apple Valley, California, United States
RECRUITINGScripps Green Hospital
Carlsbad, California, United States
RECRUITINGNational Institute of clinical Research Administration Office
Garden Grove, California, United States
Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)
Time frame: Baseline up to Week 36
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Values Calculated Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation
Time frame: Baseline up to Week 104
Percentage of Participants Achieving Complete Response (CR)
CR is defined as a UPCR value (based on 24-hour urine collection) of \< 0.5 gram per gram (g/g), a reduction in UPCR of ≥ 50%, and a stable eGFR (decrease from baseline in eGFR of ≤ 25%).
Time frame: Baseline up to Week 104
Percentage of Participants who Progressed to Kidney Malfunction
The percentage of participants progressing to kidney malfunction will be reported based on one of the following, 1. ≥ 40% Reduction in eGFR Sustained for ≥ 30 Days, 2. eGFR \<15 mL/min/1.73m\^2 for ≥ 30 Days, 3. Undergoing Dialysis for ≥ 30 Days, 4. Undergoing Kidney Transplantation, 5. Died From Kidney Failure
Time frame: Baseline up to Week 104
Percentage of Participants Requiring Rescue Therapy
Time frame: Baseline up to Week 104
Change From Baseline in eGFR Values Calculated Using the CKD-EPI Creatinine Equation
Time frame: Baseline up to Week 52
Felzartamab Serum Concentrations Over Time
Time frame: Predose and at multiple timepoints postdose up to Week 36
Number of Participants with Anti-Drug Antibodies (ADAs) Against Felzartamab
Time frame: Baseline up to Week 104
Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
Time frame: Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Abnormalities
Time frame: Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Abnormalities
Time frame: Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Physical Examinations Abnormalities
Time frame: Baseline up to Week 104
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FOMAT Medical Research - FOMAT - PPDS
Oxnard, California, United States
RECRUITINGNorth America Research Institute-San Dimas
San Dimas, California, United States
RECRUITINGNova Clinical Research, LLC
Bradenton, Florida, United States
RECRUITINGRoyal Research, Corp.
Hollywood, Florida, United States
RECRUITINGCentral Florida Kidney Specialists
Orlando, Florida, United States
RECRUITINGCDC Research Institute, LLC
Port Saint Lucie, Florida, United States
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