Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis (NCT05517980) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
52 participantsStarted 2025-03
Plain-language summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with IgAN and C3G. The study will start with enrolling the IgAN cohort. Approximately 42 participants with IgAN will be enrolled in 2 stages: Stage 1 will be used to collect safety, immunogenicity, PK, and PD data to select the optimal biologic dose (OBD) of KP104 for IgAN, as well as to preliminarily explore the effect of KP104 on C3G. Stage 2 will be used to collect safety, immunogenicity, PK, PD, and efficacy data at the OBD dose of KP104 for IgAN and C3G. As soon as the OBD for IgAN is determined, eligible participants with C3G will be enrolled and dosed at the OBD for IgAN for a minimum of 48 weeks for weekly maintenance dosing and a minimum of 47 weeks for biweekly maintenance dosing. Approximately 10 participants with C3G will be enrolled.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Weight of \>35 kilograms (kg) at Screening
* Body mass index (BMI) of \<35 kilograms per square meter (kg/m\^2)
* UPCR \>1.0 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 3 years prior to enrolment.
* 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 3 years prior to enrolment.
* 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 v…
What they're measuring
1
Percent change from Baseline in 24-hour urinary protein creatinine ratio (UPCR) at Week 24 (C3G) for participants in Stage 2