Complement-mediated Renal DiseasesPhase 2NCT07363265
Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease
A Phase 2 study testing LP-005 Injection in people with Complement-mediated Renal Diseases, run by Longbio Pharma at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complement-mediated Renal Diseases
- What is being tested?
- LP-005 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 2 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing
Minghui Zhao, 86-010-83572388, mhzhao@bjmu.edu.cn
About this study
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
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.
- Conditions
- Complement-mediated Renal Diseases
- Being tested
- LP-005 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-005 InjectionBiological
IV, Q4W
| Study group | Role | What they receive |
|---|---|---|
| LP-005 | Experimental | Patients with complement-mediated renal diseases will be treated with predefined dose of LP-005 (1200 mg or 1500 mg). Receives: Biological: LP-005 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR) in Basket 1 cohort
Measured: Week 24
Proportion of patients with a ≥25% reduction in serum creatinine (SCr) from baseline in Basket 2 cohort
Measured: Week 24
Proportion of patients without dialysis requirement in Basket 3 cohort
Measured: Week 24
Secondary outcomes (5)
Change from baseline in serum creatinine (SCr)
Measured: Up to approximately 64 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)
Measured: Up to approximately 64 weeks
Incidence of AEs
Measured: Up to approximately 64 weeks
Serum concentrations of LP-005
Measured: Up to approximately 64 weeks
Number of patients with anti-drug antibodies (ADA)
Measured: Up to approximately 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start2 Feb 2026 (estimated)
- Primary completion2 Aug 2028 (estimated)
- Study completion2 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complement-mediated Renal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Longbio Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minghui Zhao, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363265
- Sponsor's protocol ID
- P10-LP005-06
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07363265
- Acronym / sponsor ID
- P10-LP005-06
- Conditions
- Complement-mediated Renal Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Longbio PharmaIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 2 Aug 2028 (estimated)
- Study completion
- 2 May 2029 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LP-005 | Experimental | Biological: LP-005 InjectionPatients with complement-mediated renal diseases will be treated with predefined dose of LP-005 (1200 mg or 1500 mg). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP-005 InjectionIV, Q4W | Biological | LP-005 |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minghui Zhao principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LP-005 Injection in people with Complement-mediated Renal Diseases, run by Longbio Pharma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Yang (+86 021-58372390, yangj@longbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR) in Basket 1 cohort (time frame: Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.