NCT05517980RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
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)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 24 Aug 2022
- Start date
- 1 Dec 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Kira Pharmacenticals (US), LLC.
- Diseases
- IgA nephropathy
- NCT number
- NCT05517980
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 52
- From 1 Dec 2025 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- 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
- 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
Other
- Presence of crescent formation in \>50 percent (%) of glomeruli assessed on renal biopsy
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.