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This is a multicenter, open-label, proof-of-concept, phase â…¡ adaptive basket clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic profile of LP-005 Injection as add-on therapy to standard treatment in patients with complement-mediated renal diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LP-005 | Experimental | Patients with complement-mediated renal diseases will be treated with predefined dose of LP-005 (1200 mg or 1500 mg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP-005 Injection | Biological | IV, Q4W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR) in Basket 1 cohort | Week 24 | |
| Proportion of patients with a ≥25% reduction in serum creatinine (SCr) from baseline in Basket 2 cohort | Week 24 | |
| Proportion of patients without dialysis requirement in Basket 3 cohort | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum creatinine (SCr) | Up to approximately 64 weeks | |
| Change from baseline in estimated glomerular filtration rate (eGFR) | Up to approximately 64 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Yang | Contact | +86 021-58372390 | yangj@longbiopharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Minghui Zhao | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China |
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| Incidence of AEs |
| Up to approximately 64 weeks |
| Serum concentrations of LP-005 | Up to approximately 64 weeks |
| Number of patients with anti-drug antibodies (ADA) | Up to approximately 64 weeks |