Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia

Sponsor
Atom Therapeutics Co., Ltd
Study ID
NCT07323095
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ABP-671 plus febuxostat Group 1 — DRUG
    ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)
  • ABP-671 plus febuxostat Group 2 — DRUG
    ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)
  • ABP-671 Group — DRUG
    ABP-671 Dose 2 + Febuxostat placebo-tablets(PO)
  • Placebo Group — DRUG
    ABP-671 placebo-tablets(PO) + Febuxostat placebo-tablets(PO)

Study Details

This is a phase 2, international, multicenter, randomized, double blind, placebo-controlled trial to evaluate the efficacy and safety of ABP-671 in subjects with CKD and hyperuricaemia, to preliminarily evaluate the efficacy of ABP-671 in the treatment of subjects with CKD and hyperuricemia, primary Efficacy Endpoint is change in UACR from baseline to Week 40

Key Dates

First listed
Jan 7, 2026
Start date
Jun 30, 2026
Status verified
Nov 2025
Primary completion
Oct 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ABP-671 plus febuxostat Group 1
    Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice
  • Active Comparator: ABP-671 plus febuxostat Group 2
    Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice
  • Experimental: ABP-671 Group
    Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice
  • Placebo Comparator: Placebo Group
    Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice

Primary Outcome Measure

The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline [ Time Frame: Week 40 ]

Central Contacts

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