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Not yet recruitingNCT07323095Updated Jun 4, 2026

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

A Phase 2 interventional study of ABP-671 plus febuxostat Group 1 and ABP-671 plus febuxostat Group 2 in Chronic Kidney Disease, sponsored by Atom Therapeutics Co., Ltd. Not yet recruiting at 10 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Atom Therapeutics Co., Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

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

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Conditions studied

  • Chronic Kidney Disease
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In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's planned enrollment of 80 is close to the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Atom Therapeutics Co., Ltd is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female aged 18-75 years , who voluntarily participate in this clinical trial, understand and comply with the procedures stipulated in this study
  • Patients who have been diagnosed with CKD based on Clinical Practice Guideline
  • During screening, body mass index (BMI) was ≥18.0 and ≤ 40.0 kg/m2
  • The sUA levels > 420 μmol/L (7.0 mg/dL)

Exclusion criteria

Exclusion Criteria:

  • History of renal transplantation
  • The 24-hour urinary protein ≥ 3.5 g/day
  • Liver function abnormality: aspartate aminotransferase or alanine aminotransferase, or alkaline phosphatase > 3 times the upper limit of normal value (ULN)
  • Subjects with mental disorders who are unable to communicate normally with the investigator
  • Subjects who have participated in another clinical study during the screening period are within 30 days of the last dose of the study drug in another study
  • The investigator judged that the subject was not suitable for participation in this study
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
80 participants (estimated)

Study 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

    Drug: ABP-671 plus febuxostat Group 1

  • 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

    Drug: ABP-671 plus febuxostat Group 2

  • 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

    Drug: ABP-671 Group

  • 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

    Drug: Placebo Group

Interventions

  • DrugABP-671 plus febuxostat Group 1

    ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)

  • DrugABP-671 plus febuxostat Group 2

    ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)

  • DrugABP-671 Group

    ABP-671 Dose 2 + Febuxostat placebo-tablets(PO)

  • DrugPlacebo Group

    ABP-671 placebo-tablets(PO) + Febuxostat placebo-tablets(PO)

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline

    Time frame: Week 16

  2. Incidence of treatment-emergent adverse events (Safety and Tolerability)

    Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation

    Time frame: Week 40

07

Study locations

10 sites
  • Renal Research Gosford Pty Ltd
    Gosford, New South Wales 2250, Australia
  • Genesis Research services
    Newcastle, New South Wales 2019, Australia
  • Paratus Clinical Research Brisbane
    Brisbane, Queensland, Australia
  • Beijing Tsinghua Changgung Hospital
    Beijing, Beijing Municipality 100000, China
  • Peking University First Hospital
    Beijing, Beijing Municipality 100000, China
  • Xuanwu Hospital Capital Medical University
    Beijing, Beijing Municipality 100000, China
  • Jiangsu Province Hospital
    Nanjing, Jiangsu 210000, China
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality 200000, China
  • Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310000, China
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang 310000, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07323095
Lead sponsor
Atom Therapeutics Co., Ltd
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Jun 30, 2026 (estimated)
Primary completion
Oct 31, 2027 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Jun 4, 2026

Study contacts

Renbo Gao
Contact
renbo.gao@atombp.com
+86 15062305252

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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