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

Atom Therapeutics Co., Ltd

Status and phase: Not yet enrolling; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: ABP-671 plus febuxostat Group 2; Drug: ABP-671 plus febuxostat Group 1; Drug: ABP-671 Group; Drug: Placebo Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT07323095

ABP-671-202

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 4 patient groups, including a placebo group

ABP-671 plus febuxostat Group 1

Active Comparator group

Description:

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

Treatment:

Drug: ABP-671 plus febuxostat Group 1

ABP-671 plus febuxostat Group 2

Active Comparator group

Description:

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

Treatment:

Drug: ABP-671 plus febuxostat Group 2

ABP-671 Group

Experimental group

Description:

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

Treatment:

Drug: ABP-671 Group

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Group