Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis

Launched by KIRA PHARMACENTICALS (US), LLC. · Aug 24, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called KP104 for people with two specific kidney conditions: IgA nephropathy (IgAN) and C3 glomerulopathy (C3G). The main goals are to see if KP104 is effective, safe, and how it works in the body. Initially, the study will focus on enrolling about 42 patients with IgAN, where researchers will gather information on safety and determine the best dose of KP104. Once the right dose is established, they will also include around 10 participants with C3G to see how they respond to the same treatment.

To be eligible for this trial, participants need to weigh more than 35 kilograms and have a specific kidney condition confirmed by a recent biopsy. They should also be on stable medication for their kidney disease. Participants can expect to receive KP104 for at least 48 weeks, with follow-up visits to monitor their health. It's important to note that potential participants must meet certain health criteria and will need to practice effective contraception if they are of childbearing age. The trial is currently not yet recruiting, so interested individuals should keep an eye out for updates.

Gender

ALL

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 \>1.0 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.