Chronic Kidney DiseasePhase 2NCT07323095
Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
A Phase 2 study testing ABP-671 plus febuxostat Group 1, ABP-671 plus febuxostat Group 2 and ABP-671 Group in people with Chronic Kidney Disease, run by Atom Therapeutics Co., Ltd at 10 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- ABP-671 plus febuxostat Group 1, ABP-671 plus febuxostat Group 2 and ABP-671 Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 2 Oct 2026to 31 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
China7 sites, 7 recruiting
- Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000
- Not yet recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Australia3 sites, 3 recruiting
- Recruiting
Paratus Clinical Research Brisbane
Brisbane, Queensland
- Not yet recruiting
Renal Research Gosford Pty Ltd
Gosford, New South Wales, 2250
- Recruiting
Genesis Research services
Newcastle, New South Wales, 2019
About this study
Official title: 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
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
- Conditions
- Chronic Kidney Disease
- Being tested
- ABP-671 plus febuxostat Group 1, ABP-671 plus febuxostat Group 2, ABP-671 Group, Placebo Group
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP-671 plus febuxostat Group 1Drug
ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)
ABP-671 plus febuxostat Group 2Drug
ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)
ABP-671 GroupDrug
ABP-671 Dose 2 + Febuxostat placebo-tablets(PO)
Placebo GroupDrug
ABP-671 placebo-tablets(PO) + Febuxostat placebo-tablets(PO)
| Study group | Role | What they receive |
|---|---|---|
| ABP-671 plus febuxostat Group 1 | Active comparator | 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 Receives: Drug: ABP-671 plus febuxostat Group 1 |
| ABP-671 plus febuxostat Group 2 | Active comparator | 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 Receives: Drug: ABP-671 plus febuxostat Group 2 |
| ABP-671 Group | Experimental | 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 Receives: Drug: ABP-671 Group |
| Placebo Group | Placebo comparator | 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 Receives: Drug: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline
Measured: Week 40
Secondary outcomes (2)
The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline
Measured: Week 16
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
Measured: Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start2 Oct 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atom Therapeutics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323095
- Sponsor's protocol ID
- ABP-671-202
- Status last verified
- Oct 2026
- First submitted
- 8 Dec 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07323095
- Acronym / sponsor ID
- ABP-671-202
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Atom Therapeutics Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABP-671 plus febuxostat Group 1 | Active comparator | Drug: 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 2 | Active comparator | Drug: 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 Group | Experimental | Drug: 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 Group | Placebo comparator | Drug: 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABP-671 plus febuxostat Group 1ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO) | Drug | ABP-671 plus febuxostat Group 1 |
| ABP-671 plus febuxostat Group 2ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO) | Drug | ABP-671 plus febuxostat Group 2 |
| ABP-671 GroupABP-671 Dose 2 + Febuxostat placebo-tablets(PO) | Drug | ABP-671 Group |
| Placebo GroupABP-671 placebo-tablets(PO) + Febuxostat placebo-tablets(PO) | Drug | Placebo Group |
Primary outcome
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
2 secondary outcomes
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
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Time frame: Week 40
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABP-671 plus febuxostat Group 1, ABP-671 plus febuxostat Group 2 and ABP-671 Group in people with Chronic Kidney Disease, run by Atom Therapeutics Co., Ltd at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renbo Gao (+86 15062305252, renbo.gao@atombp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.