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GlomerulonephritisPhase 2NCT05517980

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

A Phase 2 study testing KP104 in people with Glomerulonephritis, run by Kira Pharmacenticals (US), LLC. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Glomerulonephritis
What is being tested?
KP104
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
1 Dec 2025to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Study Director contact

650-549-1400

privacy@kirapharma.com

China1 site, 1 recruiting

  • Peking University First Hospital

    Beijing

    Investigative Site #1

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
KP104
Keywords
KP104, Immunoglobulin A Nephropathy, Compliment-mediated Glomerulonephritis, Complement Inhibitor
Medical subject headings
Glomerulonephritis, Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KP104Drug

    Participants will receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104.

Study groups in NCT05517980
Study groupRoleWhat they receive
IgAN Cohort Stage 1 Dose 1ExperimentalParticipants 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.
Receives: Drug: KP104
C3G Cohort Stage 1 Dose 1ExperimentalParticipants 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.
Receives: Drug: KP104
IgAN Cohort Stage 1 Dose 2ExperimentalParticipants 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.
Receives: Drug: KP104
C3G Cohort Stage 1 Dose 2ExperimentalParticipants 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.
Receives: Drug: KP104
IgAN Cohort Stage 2ExperimentalParticipants will receive weekly or biweekly maintenance doses of KP104 at the OBD.
Receives: Drug: KP104
C3G Cohort Stage 2ExperimentalParticipants will receive weekly or biweekly maintenance doses of KP104 at the OBD.
Receives: Drug: KP104

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline and at Week 24

Secondary outcomes (6)

  1. 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.

    Measured: Up to 56 Weeks

  2. 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.

    Measured: Up to 56 Weeks

  3. 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.

    Measured: Up to 56 Weeks

  4. Maximum concentration (Cmax) of KP104

    Blood samples will collected at indicated timepoints to assess Cmax.

    Measured: At Baseline (Day 1), Days 8, 15, 22, 29, 43, 57, 85, 169, 253, 337, 365 and 395

  5. Trough concentration (Ctrough) of KP104 at steady state

    Blood samples will collected at indicated timepoints to assess Ctrough.

    Measured: At Baseline (Day 1), Days 8, 15, 22, 29, 43, 57, 85, 169, 253, 337, 365 and 395

  6. Change from Baseline in estimated glomerular filtration rate (eGFR) at Week 24 (C3G) for participants in Stage 2

    Measured: Baseline and at Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2022
  2. Study start1 Dec 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05517980
Sponsor's protocol ID
KP104-203
Status last verified
Oct 2026
First submitted
24 Aug 2022
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KP104 in people with Glomerulonephritis, run by Kira Pharmacenticals (US), LLC. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (650-549-1400, privacy@kirapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05517980.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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