IgA Nephropathy (IgAN)Phase 2NCT07553494
SLN12140 in Adult Participants With IgA Nephropathy in China
A Phase 2 study testing SLN12140 in people with IgA Nephropathy (IgAN), run by Linno Pharmaceuticals, Inc. at 1 site in China.
Trial summary
This study is a randomized, parallel, double-blind, placebo-controlled, subcutaneous administration Phase II dose-exploration clinical trial aimed at evaluating the efficacy, safety, PK, PD, and immunogenicity characteristics of SLN12140 at different doses in IgA nephropathy subjects who have previously received… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- SLN12140
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2026to Dec 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has fully understood the purpose, nature, methods and potential adverse reactions of this trial, volunteers to participate as a subject, is able to communicate effectively with the investigators, understands and complies with all requirements of this study, and voluntarily signs the Informed Consent Form (ICF) prior to initiation of any study procedures.
- Male and female subjects aged 18 to 80 years (inclusive) at the time of signing the ICF, with body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) 18.0-35.0 kg/m² (inclusive).
- Patients with IgA nephropathy confirmed by biopsy within the past 3 years before screening, with renal tubulointerstitial fibrosis < 50%.
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² during the screening period, calculated using the 2021 creatinine-based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- During the screening period, 24-hour urine protein-to-creatinine ratio (24h UPCR) ≥ 1.0 g/g; after completion of the run-in period, UPCR ≥ 0.75 g/g or urine protein excretion (UPE) ≥ 0.75 g/day.
- Must have received standard of care therapy for at least 12 weeks (and at a stable dose for at least 4 weeks) prior to the first dose of study medication, and agree to maintain stable dosing throughout the study period. (Note: Permitted standard of care medications in this study include ACEi/ARB and SGLT2i.)
- Males and women of childbearing potential (WOCBP; as defined by the Clinical Trials Facilitation and Coordination Group [CTFG] 2020) must agree to follow the contraception guidelines specified in the protocol from the screening period until 6 months after the last dose of study medication.
- The subject is willing to receive quadrivalent meningococcal vaccine and pneumococcal vaccine at least 14 days before dosing (for subjects vaccinated within 14 days before dosing, antibiotic prophylaxis for at least 14 days is required after the first vaccination). Re-vaccination is not required for those who have received quadrivalent meningococcal vaccine within 3 years before the first dose, or pneumococcal vaccine within 5 years before the first dose.
Who cannot join
- A known history of hypersensitivity, allergy, or anaphylactic reaction to any component of the investigational product, including hypersensitivity to human, humanized, or murine monoclonal antibodies, or known hypersensitivity to any ingredient of the product.
- Secondary IgA nephropathy as determined by the investigator, such as that caused by Henoch-Schönlein purpura, systemic lupus erythematosus, hepatitis, ankylosing spondylitis, infection, or other etiologies.
- Diagnosis of IgA vasculitis.
- Current presence or history of nephrotic syndrome.
- Clinical suspicion of IgA nephropathy with rapidly progressive glomerulonephritis in accordance with the Kidney Disease: Improving Global Outcomes (KDIGO) 2025 guidelines (≥50% decline in eGFR within 3 months prior to ICF signature, or a <50% decline but at risk of rapid renal function deterioration as assessed by the investigator).
- Clinical suspicion or biopsy-confirmed chronic kidney disease caused by any disease other than IgA nephropathy, including other glomerulopathies or podocytopathies.
- Other protocol-defined exclusion criteria may apply.
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
Beijing University 1st hospital
Beijing, Beijing Municipality
Jicheng Lv, Professor, +86-10-83575603, jichenglv@bjmu.edu.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SLN12140 in Adult Patients With Primary IgA Nephropathy
This study is a randomized, parallel, double-blind, placebo-controlled, subcutaneous administration Phase II dose-exploration clinical trial aimed at evaluating the efficacy, safety, PK, PD, and immunogenicity characteristics of SLN12140 at different doses in IgA nephropathy subjects who have previously received standard treatment (the standard treatment drugs allowed in this study include: angiotensin-converting enzyme inhibitors [ACEi], angiotensin II receptor blockers [ARB], and sodium-glucose co-transporter 2 inhibitors [SGLT2i]) but have poor control.
The study is divided into four stages, including a screening period of up to 8 weeks, an introduction period of up to 12 weeks, a 40-week double-blind period (including a 36-week treatment period and a 4-week safety follow-up period; all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will enter the open-label extension period for continued treatment after completing the double-blind period), and a 56-week open-label extension period (all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will continue SLN12140 at the same dose group [the optimal dose], including a 52-week open treatment period and a 4-week safety follow-up period).
- Conditions
- IgA Nephropathy (IgAN)
- Being tested
- SLN12140, Placebo
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLN12140Drug
SLN12140 by subcutaneous (sc) injection:100mg QW for 36 weeks in blind treatment period; SLN12140 by subcutaneous (sc) injection:200mg QW for 36 weeks in blind treatment period; SLN12140 by subcutaneous (sc) injection:600mg Q4W for 36 weeks in blind treatment period; after 36 weeks of blind treatment period, all of subjects will receive SLN12140 treatment for 52 weeks as open-label extension period with one optimal dosage.
PlaceboOther
Placebo (0.9% sodium chloride solution) will be provided as an injectable solution without active ingredient for 36 weeks in blind treatment period.
| Study group | Role | What they receive |
|---|---|---|
| SLN12140 | Experimental | SLN12140 by subcutaneous (sc) injection:100mg QW; SLN12140 by subcutaneous (sc) injection:200mg QW; SLN12140 by subcutaneous (sc) injection:600mg Q4W; Receives: Drug: SLN12140 |
| Placebo | Placebo comparator | Placebo (0.9% sodium chloride solution) will be provided as an injectable solution without active ingredient for 36 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in urine protein-to-creatinine ratio (UPCR)at Week 36
Change from baseline in Urine protein-to-creatinine ratio (UPCR) by visit.
Measured: Week 36
Secondary outcomes (14)
Mean change from baseline in urine protein-to-creatinine ratio (UPCR)at Week 24
Change from baseline in Urine protein-to-creatinine ratio (UPCR) by visit.
Measured: Week 24
Mean change from baseline in urine albumin-to-creatinine ratio (UACR) at Weeks 24, 36;
Change from baseline in Urine albumin-to-creatinine ratio (UACR) by visit.
Measured: Weeks 24, 36
Mean change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 12, 24, 36
Change from baseline in eGFR by visit
Measured: Weeks 12, 24, 36
Mean changes from baseline in 24-hour urinary protein excretion (24h-UPE) at weeks 24 and 36.
Measured: Weeks 24 and 36
Mean changes from baseline in 24-hour urinary albumin excretion (24h-UAE) at weeks 24 and 36.
Measured: Weeks 24 and 36
Mean changes from baseline in quantitative first morning void (FMV) UPCR at weeks 2, 4, 8, 12, 24, and 36.
Measured: Weeks 2, 4, 8, 12, 24, and 36.
Mean changes from baseline in quantitative FMV-UACR at weeks 2, 4, 8, 12, 24, and 36.
Measured: Weeks 2, 4, 8, 12, 24, and 36.
Number and severity of treatment-emergent adverse events
Number and intensity of adverse events
Measured: 106 weeks
Incidence of treatment-induced anti-drug antibodies
Anti-drug antibody (ADA), incidence, titers and duration
Measured: Weeks 4、8、12、24、36 and 40
Pharmacokinetics (PK)parameters of SLN12140: Area Under The Plasma Concentration-time Curve
Measured: Baseline through week 92 (predose and postdose)
PK: Maximum Plasma Concentration (Cmax)
To characterize the pharmacokinetics of SLN12140 in participants with IgAN
Measured: Baseline through week 92( predose and postdose)
PK: Time To Maximum Concentration (Tmax)
To characterize the pharmacokinetics of SLN12140 in participants with IgAN
Measured: Baseline through week 92( predose and postdose)
Complement Alternative Pathway (AP) Functional Activity
Serum AP functional activity was measured by the Wieslab functional immunoassay method.
Measured: Baseline through week 92( predose and post dose)
Complement FP
Plasma FP was measured by enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline through week 92(predose and postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start29 May 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linno Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong ZHANG, Professor, Principal investigator, Beijing University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553494
- Sponsor's protocol ID
- LIN2102-CN202
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not decided yet at this moment if we will share IPD with other researchers, or when will IPD will be shared, or with whom will IPD be shared, or by what mechanism will IPD be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SLN12140 in Adult Patients With Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT07553494
- Acronym / sponsor ID
- LIN2102-CN202
- Conditions
- IgA Nephropathy (IgAN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Linno Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Apr 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 study is a randomized, parallel, double-blind, placebo-controlled, subcutaneous administration Phase II dose-exploration clinical trial aimed at evaluating the efficacy, safety, PK, PD, and immunogenicity characteristics of SLN12140 at different doses in IgA nephropathy subjects who have previously received standard treatment (the standard treatment drugs allowed in this study include: angiotensin-converting enzyme inhibitors [ACEi], angiotensin II receptor blockers [ARB], and sodium-glucose co-transporter 2 inhibitors [SGLT2i]) but have poor control.
The study is divided into four stages, including a screening period of up to 8 weeks, an introduction period of up to 12 weeks, a 40-week double-blind period (including a 36-week treatment period and a 4-week safety follow-up period; all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will enter the open-label extension period for continued treatment after completing the double-blind period), and a 56-week open-label extension period (all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will continue SLN12140 at the same dose group [the optimal dose], including a 52-week open treatment period and a 4-week safety follow-up period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLN12140 | Experimental | Drug: SLN12140SLN12140 by subcutaneous (sc) injection:100mg QW; SLN12140 by subcutaneous (sc) injection:200mg QW; SLN12140 by subcutaneous (sc) injection:600mg Q4W; |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (0.9% sodium chloride solution) will be provided as an injectable solution without active ingredient for 36 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject has fully understood the purpose, nature, methods and potential adverse reactions of this trial, volunteers to participate as a subject, is able to communicate effectively with the investigators, understands and complies with all requirements of this study, and voluntarily signs the Informed Consent Form (ICF) prior to initiation of any study procedures.
- Male and female subjects aged 18 to 80 years (inclusive) at the time of signing the ICF, with body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) 18.0-35.0 kg/m² (inclusive).
- Patients with IgA nephropathy confirmed by biopsy within the past 3 years before screening, with renal tubulointerstitial fibrosis < 50%.
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² during the screening period, calculated using the 2021 creatinine-based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- During the screening period, 24-hour urine protein-to-creatinine ratio (24h UPCR) ≥ 1.0 g/g; after completion of the run-in period, UPCR ≥ 0.75 g/g or urine protein excretion (UPE) ≥ 0.75 g/day.
Key exclusion criteria (7 listed)
- A known history of hypersensitivity, allergy, or anaphylactic reaction to any component of the investigational product, including hypersensitivity to human, humanized, or murine monoclonal antibodies, or known hypersensitivity to any ingredient of the product.
- Secondary IgA nephropathy as determined by the investigator, such as that caused by Henoch-Schönlein purpura, systemic lupus erythematosus, hepatitis, ankylosing spondylitis, infection, or other etiologies.
- Diagnosis of IgA vasculitis.
- Current presence or history of nephrotic syndrome.
- Clinical suspicion of IgA nephropathy with rapidly progressive glomerulonephritis in accordance with the Kidney Disease: Improving Global Outcomes (KDIGO) 2025 guidelines (≥50% decline in eGFR within 3 months prior to ICF signature, or a <50% decline but at risk of rapid renal function deterioration as assessed by the investigator).
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 |
|---|---|---|
| SLN12140SLN12140 by subcutaneous (sc) injection:100mg QW for 36 weeks in blind treatment period; SLN12140 by subcutaneous (sc) injection:200mg QW for 36 weeks in blind treatment period; SLN12140 by subcutaneous (sc) injection:600mg Q4W for 36 weeks in blind treatment period; after 36 weeks of blind treatment period, all of subjects will receive SLN12140 treatment for 52 weeks as open-label extension period with one optimal dosage. | Drug | SLN12140 |
| PlaceboPlacebo (0.9% sodium chloride solution) will be provided as an injectable solution without active ingredient for 36 weeks in blind treatment period. | Other | Placebo |
Primary outcome
Mean change from baseline in urine protein-to-creatinine ratio (UPCR)at Week 36
Time frame: Week 36
Change from baseline in Urine protein-to-creatinine ratio (UPCR) by visit.
14 secondary outcomes
Mean change from baseline in urine protein-to-creatinine ratio (UPCR)at Week 24
Time frame: Week 24
Mean change from baseline in urine albumin-to-creatinine ratio (UACR) at Weeks 24, 36;
Time frame: Weeks 24, 36
Mean change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 12, 24, 36
Time frame: Weeks 12, 24, 36
Mean changes from baseline in 24-hour urinary protein excretion (24h-UPE) at weeks 24 and 36.
Time frame: Weeks 24 and 36
Mean changes from baseline in 24-hour urinary albumin excretion (24h-UAE) at weeks 24 and 36.
Time frame: Weeks 24 and 36
Mean changes from baseline in quantitative first morning void (FMV) UPCR at weeks 2, 4, 8, 12, 24, and 36.
Time frame: Weeks 2, 4, 8, 12, 24, and 36.
Mean changes from baseline in quantitative FMV-UACR at weeks 2, 4, 8, 12, 24, and 36.
Time frame: Weeks 2, 4, 8, 12, 24, and 36.
Number and severity of treatment-emergent adverse events
Time frame: 106 weeks
Incidence of treatment-induced anti-drug antibodies
Time frame: Weeks 4、8、12、24、36 and 40
Pharmacokinetics (PK)parameters of SLN12140: Area Under The Plasma Concentration-time Curve
Time frame: Baseline through week 92 (predose and postdose)
PK: Maximum Plasma Concentration (Cmax)
Time frame: Baseline through week 92( predose and postdose)
PK: Time To Maximum Concentration (Tmax)
Time frame: Baseline through week 92( predose and postdose)
Complement Alternative Pathway (AP) Functional Activity
Time frame: Baseline through week 92( predose and post dose)
Complement FP
Time frame: Baseline through week 92(predose and postdose)
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 28 Apr 2026.
- Individual participant dataSharing planned: Undecided. It is not decided yet at this moment if we will share IPD with other researchers, or when will IPD will be shared, or with whom will IPD be shared, or by what mechanism will IPD be shared.
Related trials for IgA Nephropathy (IgAN)
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)
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.
Hong ZHANG, Professor principal investigator
Beijing 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 SLN12140 in people with IgA Nephropathy (IgAN), run by Linno Pharmaceuticals, Inc. 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 8 inclusion and 7 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 28 Apr 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. Some participants in this study may receive a placebo. 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 Jicheng lv, Professor (0086-10-83575603, jichenglv@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in urine protein-to-creatinine ratio (UPCR)at Week 36 (time frame: Week 36). 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 28 Apr 2026.