- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05517980
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
August 9, 2023 updated by: Kira Pharmacenticals (US), LLC.
An Open-label, Phase 2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 in Subjects With IgA Nephropathy (IgAN) and Complement 3 Glomerulopathy (C3G)
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Director
- Email: privacy@kirapharma.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 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 defined as presence of substantial proteinuria (> 3.5 g/24 hours), hypoalbuminemia (< 30 grams per liter [g/L]), and edema/hyperlipidemia. Nephrotic range proteinuria alone is acceptable.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IgAN Cohort Stage 1 Dose 1
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 receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104.
|
Experimental: IgAN Cohort Stage 1 Dose 2
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 loading and/or weekly maintenance subcutaneous (SC) doses of KP104.
|
Experimental: IgAN Cohort Stage 2
Participants will receive weekly or biweekly maintenance doses of KP104 at the OBD.
|
Participants will receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104.
|
Experimental: C3G Cohort Stage 1 Dose 1
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 receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104.
|
Experimental: C3G Cohort Stage 1 Dose 2
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 loading and/or weekly maintenance subcutaneous (SC) doses of KP104.
|
Experimental: C3G Cohort Stage 2
Participants will receive weekly or biweekly maintenance doses of KP104 at the OBD.
|
Participants will receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: Baseline and at Week 24
|
The UPCR will be calculated as percent change in protein (Pr)/ Creatinine (Cr).
|
Baseline and at Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants reporting Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 56 Weeks
|
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.
|
Up to 56 Weeks
|
Number of participants reporting Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Up to 56 Weeks
|
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)
Time Frame: Up to 56 Weeks
|
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
Time Frame: At Baseline (Day 1), Days 8, 15, 22, 29, 43, 57, 85, 169, 253, 337, 365 and 395
|
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
Time Frame: At Baseline (Day 1), Days 8, 15, 22, 29, 43, 57, 85, 169, 253, 337, 365 and 395
|
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
Time Frame: Baseline and at Week 24
|
Baseline and at Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2023
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
August 24, 2022
First Submitted That Met QC Criteria
August 24, 2022
First Posted (Actual)
August 26, 2022
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KP104-203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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