This is a multicenter, open-label, proof-of-concept, phase Ⅱ 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
IV, Q4W
Peking University First Hospital
Beijing, China
Change from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR) in Basket 1 cohort
Time frame: Week 24
Proportion of patients with a ≥25% reduction in serum creatinine (SCr) from baseline in Basket 2 cohort
Time frame: Week 24
Proportion of patients without dialysis requirement in Basket 3 cohort
Time frame: Week 24
Change from baseline in serum creatinine (SCr)
Time frame: Up to approximately 64 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)
Time frame: Up to approximately 64 weeks
Incidence of AEs
Time frame: Up to approximately 64 weeks
Serum concentrations of LP-005
Time frame: Up to approximately 64 weeks
Number of patients with anti-drug antibodies (ADA)
Time frame: Up to approximately 64 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.