This main purpose of this study was to evaluate the safety, tolerability, dose response and efficacy of Atacicept in participants with IgA nephropathy and persistent proteinuria. The study hypothesis was that treatment with Atacicept would reduce proteinuria compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
AKDHC Medical Research Services, LLC.
Glendale, Arizona, United States
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
Adverse Event (AE): any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: AEs that developed or worsened/became serious during on-treatment period (time from the first dose of study drug up to the end of study \[Week 96\]). TEAEs included serious AEs and non- serous AEs. AESIs included infections, cardiac failure, cardiomyopathy/ ischemic heart disease, hypersensitivity reaction (including anaphylactic/anaphylactoid shock conditions, asthma/bronchospasm, and angioedema), injection site reactions (ISRs) and demyelinating disorders. Investigator or his /her designee assessed ISRs as local reactions (redness, bruising, swelling, induration and itching).
Time frame: Baseline up to 96 weeks
Serum Atacicept Concentrations
Serum Atacicept Concentrations was to be performed; however; as per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.
Time frame: Week 0 Day 1 (pre-dose), Weeks 1, 2, 4, 8, 12, 16, 24, 40, 48, 72, Early Termination (up to Week 72) and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
The change in serum levels of IgA from baseline was reported.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
The change in serum levels of IgG from baseline was reported.
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California Institute of Renal Research - Chula Vista Location
Chula Vista, California, United States
Colorado Kidney Care PC - Dr. Marder
Denver, Colorado, United States
Medical Faculty Associates
Washington D.C., District of Columbia, United States
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, United States
GA Nephrology Associates
Lawrenceville, Georgia, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
...and 8 more locations
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24
Change From Baseline Levels in Serum Immunoglobulin M (IgM)
The change in serum levels of IgM from baseline was reported.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and at PT FU Weeks 4, 12 and 24
Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels
The change in serum Gd-IgA1 from baseline was reported.
Time frame: Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24
Change From Baseline in Serum Complement C3 and C4 Levels
The change in serum component C3 and C4 from baseline were reported.
Time frame: Baseline, Week 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24
Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis
Change from baseline in immune cell subsets included total T cells, helper T cells, cytotoxic T cells, total B cells (assay with \[AW\] CD45 or assay without \[AWO\] CD45), mature naïve B cells, memory B cells, plasma cells, plasma blasts, and natural killer (NK) cells and were reported. Analysis was performed by flow cytometry analysis.
Time frame: Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24
Change From Baseline in Urinary IgG, IgA, and IgM Levels
Urinary IgG, IgA and IgM levels to be measured by Immuno-Electrophoresis.
Time frame: Baseline (Day1), Weeks 24, 48 and Early Termination (up to earlier than Week 72)
Percentage of Participants With Positive Anti-Drug Antibody (ADA)
Percentage of participants with positive ADA were reported.
Time frame: Baseline up to safety follow-up (96 weeks)
Percentage of Participants With Clinical Significant Abnormalities in Laboratory Assessments
Laboratory investigation included hematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator.
Time frame: Baseline up to safety follow-up (96 weeks)
Percentage of Participants With Clinical Significant Abnormalities in Vital Signs
Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, weight and height. The systolic and diastolic blood pressure and pulse rate was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was to be decided by the investigator.
Time frame: Baseline up to safety follow-up (96 weeks)
Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs)
12-lead ECG were recorded after the participants have rested for at least 15 minutes in supine position. Clinically significance was decided by the investigator. The number of participants with clinically significant abnormalities in 12-lead ECG were reported.
Time frame: Baseline up to safety follow-up (96 weeks)