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NCT05517980

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

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 2 years 8 months later.

See at-risk trials from Kira Pharmacenticals (US), LLC.

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Dec 2028 Show 5 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Mar 2025 to Dec 1, 2025
    • Eligibility criteria shortened, about 36 words
    • Study sites: 0 to 1
    • Secondary endpoints: details revised at 2 of 6 entries
  2. Start date: Aug 2023 to Mar 2025
    • Primary completion date: Sep 2025 to Mar 2026
    • Study completion date: Sep 2025 to Apr 2027
    v4
  3. Start date: Jul 1, 2023 to Aug 2023v3 Show 4 more changesShow less
    • Eligibility criteria expanded, about 31 words
    • Primary endpoints: 4 to 1
    • Secondary endpoints: 10 to 6
    • Study arms: 4 to 6
  4. Start date: Dec 2022 to Jul 1, 2023v2
  5. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Percent change from Baseline in 24-hour urinary protein creatinine ratio (UPCR) at Week 24 (C3G) for participants in Stage 2
Timeframe: Baseline and at Week 24

Secondary (6)

Number of participants reporting Treatment-Emergent Adverse Events (TEAEs)
Number of participants reporting Treatment-Emergent Serious Adverse Events (TESAEs)
Number of participants reporting AEs of Special Interest (AESIs)
Maximum concentration (Cmax) of KP104
Trough concentration (Ctrough) of KP104 at steady state
Show 1 moreShow less
Change from Baseline in estimated glomerular filtration rate (eGFR) at Week 24 (C3G) for participants in Stage 2

Arms and interventions

IgAN Cohort Stage 1 Dose 1Experimental

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.

C3G Cohort Stage 1 Dose 1Experimental

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.

IgAN Cohort Stage 1 Dose 2Experimental

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.

C3G Cohort Stage 1 Dose 2Experimental

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.

IgAN Cohort Stage 2Experimental

Participants will receive weekly or biweekly maintenance doses of KP104 at the OBD.

C3G Cohort Stage 2Experimental

Participants will receive weekly or biweekly maintenance doses of KP104 at the OBD.

Drugs: KP104

Sites

1 site in 1 country

  • Peking University First HospitalBeijing, China