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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP-671 plus febuxostat Group 1 | Drug | ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO) |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renbo Gao | Contact | +86 15062305252 | renbo.gao@atombp.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renal Research Gosford Pty Ltd | Gosford | New South Wales | 2250 | Australia | ||
| Genesis Research services |
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| 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) |
|
| Week 40 |
| Newcastle |
| New South Wales |
| 2019 |
| Australia |
| Paratus Clinical Research Brisbane | Brisbane | Queensland | Australia |
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | 100000 | China |
| Peking University First Hospital | Beijing | Beijing Municipality | 100000 | China |
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210000 | China |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200000 | China |
| Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310000 | China |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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