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

NCT07323095 — Phase 2, Not yet recruiting, 80 participants, Atom Therapeutics Co., Ltd

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A Phase 2, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia

RegistryNCT07323095
StatusNot yet recruiting
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment80 (Estimated)
SponsorAtom Therapeutics Co., Ltd (Industry)
ConditionsChronic Kidney Disease
InterventionsABP-671 plus febuxostat Group 1, ABP-671 plus febuxostat Group 2, ABP-671 Group, Placebo Group (Drug)
Datesstart 2026-06-30 (estimated), primary completion 2027-10-31 (estimated), completion 2028-01-31 (estimated), first posted 2026-01-07, last updated 2026-06-04
Locations10 sites in Australia, China

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Kidney Disease All trials of ABP-671 plus febuxostat Group 1 All trials of ABP-671 plus febuxostat Group 2

-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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+Arms and interventions

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

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline [Week 16]
  • Incidence of treatment-emergent adverse events (Safety and Tolerability) [Week 40]: Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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:

* 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

+Locations (10)

FacilityCityCountryStatus
Renal Research Gosford Pty LtdGosford, New South WalesAustralia
Genesis Research servicesNewcastle, New South WalesAustralia
Paratus Clinical Research BrisbaneBrisbane, QueenslandAustralia
Beijing Tsinghua Changgung HospitalBeijing, Beijing MunicipalityChina
Peking University First HospitalBeijing, Beijing MunicipalityChina
Xuanwu Hospital Capital Medical UniversityBeijing, Beijing MunicipalityChina
Jiangsu Province HospitalNanjing, JiangsuChina
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, Shanghai MunicipalityChina
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of MedicineHangzhou, ZhejiangChina
Zhejiang Provincial People's HospitalHangzhou, ZhejiangChina