Language: BG BG
← Back to results
Not yet recruiting Phase 2 NCT07323095

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

Phase 2 – studying effectiveness and dosage
Conditions: Chronic Kidney Disease

Sponsor: Atom Therapeutics Co., Ltd

trial.available_in: БГ
Overview
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
Who can participate
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
Interventions
ABP-671 plus febuxostat Group 1
DRUG
ABP-671 plus febuxostat Group 2
DRUG
ABP-671 Group
DRUG
Placebo Group
DRUG
Locations 9
Australia (2)
Paratus Clinical Research Brisbane
Brisbane , Queensland
Genesis Research services
Newcastle , New South Wales
China (7)
Beijing Tsinghua Changgung Hospital
Beijing , Beijing Municipality
Peking University First Hospital
Beijing , Beijing Municipality
Xuanwu Hospital Capital Medical University
Beijing , Beijing Municipality
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou , Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou , Zhejiang
Jiangsu Province Hospital
Nanjing , Jiangsu
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai , Shanghai Municipality
Technical details
Status
Not yet recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
30.06.2026
Completion date
31.01.2028
Registry ID
NCT07323095
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.