Kidney Disease, Glomerulonephritis
Conditions
Interventions
TAK-079 (Mezagitamab)
Mezagitamab, subcutaneous injection, once weekly for 8 weeks then once every 2 weeks for 16 weeks in the Main Study. Same dosing regimen will be repeated in LTE Retreatment Perio
Sponsors
Nishizawa Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Renal biopsy report supporting diagnosis of primary IgAN or IgA vasculitis-associated nephritis within 10 years prior to the screening visit. 2.Urine protein to creatinine ratio (UPCR) greater than or equal to (>=) 1 milligram per milligram (mg/mg) or urine protein excretion (UPE) >=1 gram per day (g/day) by 24-hour urine collection during the screening period. 3.Estimated glomerular filtration rate (eGFR) >=45 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) at screening. 4.Receiving stable background therapy for IgAN (angiotensin-converting enzyme inhibitor [ACE-I] or angiotensin receptor blocker [ARB]) for 12 weeks prior to screening. The ACE-I and ARB dose should represent the maximum tolerated or maximum labeled dose, as determined by the investigator, for a minimum of 3 months and remain stable during the entire duration of the study.
Exclusion criteria
Exclusion criteria: 1.Kidney biopsy confirming significant renal disease other than IgAN. 2.Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies). 3.Evidence of rapidly progressive glomerulonephritis (loss of >=50 percent (%) of eGFR within 3 months prior to the screening visit). 4.Diagnosis of nephrotic syndrome defined as 24-hour proteinuria greater than (>) 3.5 g/day, hypoalbuminemia (smaller than [8% at the screening visit. 17.Current malignancy or history of malignancy during the previous 5 years, except adequately treated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Main Study: Percentage of Participants With one or More Treatment-emergent Adverse Events (TEAEs), Grade 3 or Higher TEAEs, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Mezagitamab Discontinuation Time Frame: Up to Week 48 The severity of TEAEs will be graded using National cancer institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. 2.LTE Observation Period: Percentage of Participants With one or More TEAEs, Grade 3 or Higher TEAEs and SAEs Time Frame: Up to Week 96 The severity of TEAEs will be graded using NCI-CTCAE version 5.0. 3.LTE Retreatment Period: Percentage of Participants With one or More TEAEs, SAEs, Grade 3 or Higher TEAEs and AEs leading to Mezagitamab Discontinuation Time Frame: Retreatment Week 0 to 48 The severity of TEAEs will be graded using NCI-CTCAE version 5.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Main Study: Ctrough: Observed Serum Trough Concentrations of Mezagitamab Time Frame: Week 0 Pre-dose and at multiple time points (up to Week 48) 2.Main Study: Serum IgA Levels Time Frame: Week 0 Pre-dose and at multiple time points (up to Week 48) 3.Main Study: Percent Change From Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR) Time Frame: Week 36 UPCR is calculated by dividing the concentration of protein (milligram per deciliter [mg/dL]) in urine by the urine creatinine concentration (mg/dL). 4.Main Study: Percentage of Participants Based on Antidrug Antibody (ADA) Levels in Serum Time Frame: Up to Week 48 Percentage of participants in each category of the immunogenicity status (ADA-negative, ADA-positive and titer) will be determined in this study. 5.LTE Observation Period: Serum IgA Levels Time Frame: Week 56 Pre-dose and at multiple time points (up to Week 96) 6.LTE Observation Period: Percent Change From Baseline in Proteinuria Based on UPCR Time Frame: Up to Week 96 UPCR is calculated by dividing the concentration of protein (mg/dL) in urine by the urine creatinine concentration (mg/dL). 7.LTE Observation Period: Percentage of Participants Based on ADA Levels in Serum Time Frame: Up to Week 96 Percentage of participants in each category of the immunogenicity status (ADA-negative, ADA-positive and titer) will be determined in this study. 8.LTE Retreatment Period: Percentage of Participants Based on ADA Levels in Serum Time Frame: Up to Retreatment Week 48 Percentage of participants in each category of the immunogenicity status (ADA-negative, ADA-positive and titer) will be determined in this study. | — |
Countries
Australia, China, Hungary, Italy, Japan, Singapore, South Korea, Spain, Taiwan, UK, USA
Contacts
Public ContactTrial Information Contact for Clinical
Takeda Pharmaceutical Company Limited
Outcome results
None listed