A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
ConditionKidney Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo.
Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed by chance in either the mezagitamab or placebo treatment group at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. Participants can be in the study for 2 years (104 weeks). Participants will receive study treatment for about half a year (22 weeks) and then be observed for the remainder of the study (about 1.5 years). During observation, participants will continue to have check-ups about every month.
In the open-label group, a small number of participants who either have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab.
During the study, participants will visit their study clinic several times.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Either UPCR greater than or equal to (≥) 0.8 gram per gram (g/g) or urine protein excretion (UPE) ≥1 grams per day (g/day), calculated from at least one 24-hour urine collection during the screening period (or pre-screening, if applicable) (only applicable for the main trial).
eGFR greater than (>)30 milliliters per minute per 1.73 meter square (mL/min/1.73m²) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main trial).
No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (except for open-label cohort participants meeting Inclusion Criterion No. 10.a).
The participant is aged ≥ 18 years or the local legal age as applicable.
Disqualifiers
Kidney biopsy exhibiting significant concomitant renal disease other than IgAN (for example, diabetic nephropathy, lupus nephritis, minimal change disease).
Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies), and immunoglobulin A (IgA) vasculitis.
Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF).
Diagnosis of nephrotic syndrome defined as 24-hour proteinuria >3.5 g/day and hypoalbuminemia (<3.0 grams per deciliter [g/dL]) with or without peripheral edema.
Trial design
Design model
Parallel
Treatments tested in this trial
Mezagitamab
DrugMezagitamab injections administered SC.
Placebo
DrugMezagitamab-matching placebo injections administered SC.
Treatment groups
347 Participants
are divided into 3 treatment groupsGroup A: MezagitamabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Open-label MezagitamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Proteinuria at Week 36
Proteinuria will be assessed by urine protein to creatinine ratio (UPCR) calculated from a 24-hour urine collection.
Time frame
From Baseline to Week 36Secondary outcomes
1
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 and 104, Respectively
Time frame
From Baseline to Weeks 52 and 1042
The Rate of Change in eGFR From Baseline at Week 104
The rate of change in eGFR from baseline is measured as eGFR total slope.
Time frame
From Baseline to Week 1043
Time From Baseline to the First Occurrence of Sustained Decline in eGFR of ≥30 Percent (%) From Baseline Over at Least 4 Weeks
Time frame
From Baseline to Week 1044
Time from Baseline to the First Occurrence of Any of the Pre-specified Kidney Failure Composite Assessment Criteria
The pre-specified assessment criteria will include: sustained decline in eGFR of ≥30% from baseline over at least 4 weeks; sustained eGFR \<15 mL/min/1.73 m\^2 over at least 4 weeks; initiation of maintenance dialysis defined as dialysis performed for at least 4 weeks; receipt of kidney transplant; or death from kidney failure. Time from baseline to first occurrence of any of the above assessment criteria would be reported.
Time frame
From Baseline to Week 104 Source ClinicalTrials.gov