Chronic Kidney Disease
Conditions
Brief 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
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)
Sponsors
Atom Therapeutics Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline | Week 40 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia, China
Contacts
CONTACTRenbo Gao
Outcome results
None listed