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Not yet recruiting NCT07363265

Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease

Phase II Interventional Complement-mediated Renal Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LP-005 Injection.
Who it may be relevant to
Registry conditions: Complement-mediated Renal Diseases. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Open-label Phase Ⅱ Study to Evaluate the Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease

Overview

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.

Interventions

  • Biological LP-005 Injection
    IV, Q4W

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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/m\^2 (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.
  • Willing to participate in this clinical trial and voluntarily sign the informed consent form; additionally, be assessed by the investigator as being able to fully understand and comply with all planned study procedures and other requirements.

Exclusion criteria

  • 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.
  • Patients with known hypersensitivity to any component of LP-005 or a history of atopic diathesis.
  • History of malignancy within 5 years prior to screening, except for resected cutaneous basal cell carcinoma, resected cutaneous squamous cell carcinoma, and completely resected carcinoma in situ without evidence of local recurrence or metastasis (e.g., cervical carcinoma in situ or breast carcinoma in situ).
  • Prior use of any complement inhibitor within 3 months prior to screening or 5 half-lives of the drug, whichever is longer.
  • Participation in another clinical trial with administration of investigational drug or medical device within 4 weeks prior to screening or 5 half-lives of the administered product, whichever applies.
  • Any condition that, in the investigator's judgment, may impede study participation, pose a safety risk to the participant, or confound the interpretation of study results.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Identifiers

NCT: NCT07363265 · P10-LP005-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗