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.
Males or females aged 18 to 65 years at screening.
Body weight of ≥ 40 kg and a body mass index (BMI) within the range of 15 to 35 kg/m² (inclusive).
Patients with complement-mediated renal disease.
Females and males of childbearing potential (including the participants' partners) must agree to use effective contraceptive measures during the trial and for 3 months after the trial ends.
Pregnant or lactating female.
History of meningococcal infection.
Active, uncontrolled acute, chronic, or recurrent infection within 4 weeks prior to screening.
Other severe, poorly controlled comorbidities within 3 months prior to screening.
Single group
LP-005 Injection
Biological/VaccineIV, Q4W
Change from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR) in Basket 1 cohort
Proportion of patients with a ≥25% reduction in serum creatinine (SCr) from baseline in Basket 2 cohort
Proportion of patients without dialysis requirement in Basket 3 cohort
Change from baseline in serum creatinine (SCr)
Change from baseline in estimated glomerular filtration rate (eGFR)
Incidence of AEs
Serum concentrations of LP-005
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This trial is not recruiting at the moment. You can still explore other options:
