Immunoglobulin A (IgA) Nephropathy
Conditions
Keywords
Kidney Disease, Urologic Disease, Glomerular Disease, Berger Disease, Glomerulonephritis, IGA
Brief summary
Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN
Detailed description
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Interventions
DRUGFelzartamab
anti-CD38+ monoclonal antibody
OTHERPlacebo
Placebo comparator
Sponsors
HI-Bio, A Biogen Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form \[ICF\]), but at least of legal age in the given country * Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF * Proteinuria at screening visit ≥ 1.0 g/d. * Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for ≥ 3 months prior to date of informed consent and adequate blood pressure (BP) control. * A female of childbearing potential (FCBP), is only eligible to participate if she is not pregnant, not breast feeding, and agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of IMP Key
Exclusion criteria
* Hemoglobin \< 90 g/L * Thrombocytopenia: Platelets \< 100.0 x 10\^9/L. * Neutropenia: Neutrophils \< 1.5 x 10\^9/L. * Leukopenia: Leukocytes \< 3.0 x 10\^9/L * Diabetes mellitus type 1 * Aspartate aminotransferase or alanine aminotransferase \>1.5 x ULN, alkaline phosphatase \>3.0 x ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Relative change in Proteinuria value | 9 months compared to baseline |
Secondary
| Measure | Time frame |
|---|---|
| Safety: determined by the frequency, incidence and severity of TEAEs | Ongoing through study completion, up to 2 years |
| Efficacy: Relative change in proteinuria value | Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years |
| Efficacy: complete response in patients with IgAN | Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years |
| Pharmacokinetic: serum concentrations of Felzartamab over time | Ongoing through treatment completion, up to 2 years |
Countries
Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Japan, Malaysia, Philippines, Serbia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Outcome results
None listed