Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
About this trial
This is an interventional treatment trial for Glomerulonephritis focused on measuring KP104, Immunoglobulin A Nephropathy, Compliment-mediated Glomerulonephritis, Complement Inhibitor
Eligibility Criteria
Inclusion Criteria:
- Weight of >35 kilograms (kg) at Screening
- Body mass index (BMI) of <35 kilograms per square meter (kg/m^2)
- UPCR >1.5 grams per gram (g/g) by 24-hour urine collection at Screening
- Documented diagnosis and clinical status of IgAN or C3G as follows:
IgAN:
- Diagnosis of IgAN verified by biopsy taken within the past 12 months
- On stable regimen of angiotensin converting enzyme or angiotensin blocking agents for 12 weeks and/or sodium-glucose cotransporter-2 (SGLT2) inhibitors for 6 weeks at Screening
C3G:
- Diagnosis of C3G verified by biopsy taken within the past 12 months
On stable regimen of angiotensin converting enzyme or angiotensin blocking agents for 12 weeks and/or SGLT2 inhibitors for 6 weeks at Screening
- Females of childbearing potential and males must practice effective contraception from Screening until 28 days after the end of study (EOS) visit.
- Females of childbearing potential must have a negative pregnancy test at Screening and within 1 day prior to dosing of study drug
Exclusion Criteria:
- Any clinically significant, poorly controlled underlying illness other than IgAN or C3G, as determined by the investigator
- Treatment of any infection with IV (within 30 days of Screening) or oral (within 14 days of Screening) antibiotics, antivirals, or antifungals
- History of infections with encapsulated organisms
- History of untreated tuberculosis
- Positive serology for hepatitis C virus (HCV) ribonucleic acid (RNA) or human immunodeficiency virus (HIV) at Screening
- History of bone marrow or stem cell transplantation
- Absolute neutrophil count (ANC) <500 cells per microliter (cells/μL)
- eGFR <30 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- Presence of crescent formation in >50 percent (%) of glomeruli assessed on renal biopsy
- Nephrotic syndrome
- Rapidly progressive glomerulonephritis, defined as a fall in eGFR of > 30 mL/min/1.73 m^2 within 24 weeks prior to the Screening Visit
- Receiving renal replacement therapy or anticipated to require renal replacement therapy during the duration of the study
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
IgAN Cohort Stage 1 Dose 1
C3G Cohort Stage 1 Dose 1
IgAN Cohort Stage 1 Dose 2
C3G Cohort Stage 1 Dose 2
IgAN Cohort Stage 2
C3G Cohort Stage 2
Participants will be randomized to receive weekly or biweekly maintenance doses of KP104 at Dose 1. Participants in Stage 1 will also have the opportunity to be switched to the OBD if they are still in the treatment period.
Participants will be randomized to receive weekly or biweekly maintenance doses of KP104 at Dose 1. Participants in Stage 1 will also have the opportunity to be switched to the OBD if they are still in the treatment period.
Participants will be randomized to receive weekly or biweekly maintenance doses of KP104 at Dose 2. Participants in Stage 1 will also have the opportunity to be switched to the OBD if they are still in the treatment period.
Participants will be randomized to receive weekly or biweekly maintenance doses of KP104 at Dose 2. Participants in Stage 1 will also have the opportunity to be switched to the OBD if they are still in the treatment period.
Participants will receive weekly or biweekly maintenance doses of KP104 at the OBD.
Participants will receive weekly or biweekly maintenance doses of KP104 at the OBD.