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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgAN Cohort Stage 1 Dose 1 | Experimental | 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. |
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| C3G Cohort Stage 1 Dose 1 | Experimental | 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. |
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| IgAN Cohort Stage 1 Dose 2 | Experimental | 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. |
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| C3G Cohort Stage 1 Dose 2 | Experimental | 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. |
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| IgAN Cohort Stage 2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KP104 | Drug | Participants will receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from Baseline in 24-hour urinary protein creatinine ratio (UPCR) at Week 24 (C3G) for participants in Stage 2 | The UPCR will be calculated as percent change in protein (Pr)/ Creatinine (Cr). | Baseline and at Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease or any worsening of a pre-existing condition temporally associated with the use of a study drug, whether or not related to study drug. A TEAE is defined as any AE that started or worsened in severity on or after the first dose of study treatment. |
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Inclusion Criteria:
IgAN:
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
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | privacy@kirapharma.com |
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| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Participants will receive weekly or biweekly maintenance doses of KP104 at the OBD.
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| C3G Cohort Stage 2 | Experimental | Participants will receive weekly or biweekly maintenance doses of KP104 at the OBD. |
|
| Up to 56 Weeks |
| Number of participants reporting Treatment-Emergent Serious Adverse Events (TESAEs) | A TESAE is defined as a serious AE (SAE) that started or worsened in severity on or after the first dose of study treatment. | Up to 56 Weeks |
| Number of participants reporting AEs of Special Interest (AESIs) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease or any worsening of a pre-existing condition temporally associated with the use of a study drug, whether or not related to study drug. Number of participants with AESIs including infections and local or systemic administration reactions will be assessed. | Up to 56 Weeks |
| Maximum concentration (Cmax) of KP104 | Blood samples will collected at indicated timepoints to assess Cmax. | At Baseline (Day 1), Days 8, 15, 22, 29, 43, 57, 85, 169, 253, 337, 365 and 395 |
| Trough concentration (Ctrough) of KP104 at steady state | Blood samples will collected at indicated timepoints to assess Ctrough. | At Baseline (Day 1), Days 8, 15, 22, 29, 43, 57, 85, 169, 253, 337, 365 and 395 |
| Change from Baseline in estimated glomerular filtration rate (eGFR) at Week 24 (C3G) for participants in Stage 2 | Baseline and at Week 24 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |