Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease (NCT07363265) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease
China46 participantsStarted 2026-02-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR) in Basket 1 cohort
Timeframe: Week 24
2
Proportion of patients with a ≥25% reduction in serum creatinine (SCr) from baseline in Basket 2 cohort
Timeframe: Week 24
3
Proportion of patients without dialysis requirement in Basket 3 cohort
. 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.