KP104 for IgA Nephropathy and C3G

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional trial evaluating KP104 in adults with IgA nephropathy (IgAN) and complement-mediated glomerulonephritis (C3G). The study starts with an IgAN cohort (about 42 participants) in two stages to determine the optimal biologic dose and to gather safety, immunogenicity, pharmacokinetics, and pharmacodynamics data, with preliminary exploration in C3G. Once the IgAN optimal dose is identified, eligible C3G participants will be enrolled and dosed at the same level for a maintenance period of up to 48 weeks weekly or 47 weeks biweekly. Primary endpoints include safety and pharmacodynamic responses, with efficacy data collected at the optimal biologic dose. Lead sponsor is Kira Pharmaceuticals (US), LLC, with a site at Peking University First Hospital in Beijing, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Study Director
• Email: privacy@kirapharma.com
• Phone: 650-549-1400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.