A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Backg… (NCT05174221) | Clinical Trial Compass
CompletedPhase 1
A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy
United States, Australia17 participantsStarted 2022-11-09
Plain-language summary
This study will have two parts. The main aims are to:
* check the side effects from mezagitamab.
* check for long-term side effects from mezagitamab.
Before starting the study, participants will be asked to provide a 24-hour urine sample. A few weeks later, if enrolled they will begin receiving a subcutaneous injection (under the skin) of mezagitamab once a week for 8 weeks then once every 2 weeks for 16 weeks. When treatment has ended, there will be a 24-week follow-up period.
Participants who receive benefit from the treatment may continue in the second part of the study where they will be monitored for up to 96 weeks and possibly retreated for another 24 weeks.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Renal biopsy report supporting diagnosis of primary IgAN or IgA vasculitis-associated nephritis within 10 years prior to the screening visit.
✓. 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.
✓. Estimated glomerular filtration rate (eGFR) \>=45 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2) at screening.
✓. 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
✕. Kidney biopsy confirming significant renal disease other than IgAN.
✕. Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies).
✕. Evidence of rapidly progressive glomerulonephritis (loss of \>=50 percent (%) of eGFR within 3 months prior to the screening visit).
What they're measuring
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
Timeframe: Up to Week 48
2
LTE Observation Period: Percentage of Participants With one or More TEAEs, Grade 3 or Higher TEAEs and SAEs
Timeframe: Up to Week 96
3
LTE Retreatment Period: Percentage of Participants With one or More TEAEs, SAEs, Grade 3 or Higher TEAEs and AEs leading to Mezagitamab Discontinuation
✕. Diagnosis of nephrotic syndrome defined as 24-hour proteinuria greater than (\>) 3.5 g/day, hypoalbuminemia (smaller than \[\<\] 30 g/L) with or without peripheral edema at the screening visit.
✕. Diagnosis of acute active extrarenal IgA vasculitis (Henoch-Schönlein purpura) manifested by the involvement of other organs (palpable purpura, abdominal pain, and arthritis) at the screening visit and within 1 year prior to the screening visit.
✕. Previous treatment with immunosuppressive agents such as cyclophosphamide, mycophenolate mofetil (MMF), cyclosporine, azathioprine, calcineurin inhibitors within 6 months prior to the screening visit or expected use of any of these agents for the duration of the study.
✕. Use of systemic corticosteroids within 4 months from screening visit or expected use for the duration of the study.
✕. Participation in another investigational study within 4 weeks or 5 half-lives of study drug, whichever is longer, before the screening visit (the 4-week window is derived from the date of the last study procedure, and/or AE related to the study procedure in the previous study, to the screening visit of the current study) or expected use of an investigational agent from another investigational study during the time of this study.