IgAN - IgA NephropathyPhase 2NCT07730632
Phase II Clinical Study on the Efficacy and Safety of QLS7305 in Patients With Kidney Disease (Part A)
A Phase 2 study testing QLS7305 Injection in people with IgAN - IgA Nephropathy and Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
QLS7305 injection is a chemically synthesized double-stranded small interfering RNA (siRNA) targeting complement C3, covalently linked to a ligand containing N-acetylgalactosamine (GalNAc) residues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgAN - IgA Nephropathy, Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), C3 Glomerulopathy (C3G)
- What is being tested?
- QLS7305 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2026to 11 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight ≥ 40 kg, Body Mass Index (BMI) < 32.5 kg/m²
- Within the five years prior to screening, patients must have been diagnosed with primary IgAN or PMN through renal biopsy, or within one year prior to screening, diagnosed with C3G or IC-MPGN through renal biopsy, accompanied by glomerular C3 deposition; if a renal biopsy has not been previously performed, a renal biopsy must be conducted during the screening period to confirm eligibility criteria.
- Participants with IgAN and C3G/IC-MPGN: During the screening period, morning urine UPCR or 24-hour UPCR ≥0.75 g/g or 24-hour UP ≥1 g/day, with the average of two 24-hour UPCR measurements at baseline ≥0.75 g/g; PMN participants: During the screening period, morning urine or 24-hour UP ≥3.5 g/day, with the average of two 24-hour UP measurements at baseline ≥3.5 g/day.
- During the screening and baseline periods, eGFR ≥ 30 ml·min-¹·1.73 m-² (using the CKD-EPI formula)
- Prior to the first administration, the patient should have received the maximum tolerated dose or the maximum dose recommended in the instructions of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) for at least 12 weeks, and the dose of the ACEi or ARB should have been stable for at least 4 weeks before the first administration.
- Voluntarily receive meningococcal and pneumococcal vaccines at least 2 weeks before the first administration of the investigational drug in accordance with the protocol requirements.
- From the time of signing the informed consent form until 12 months after the last administration of the investigational drug, there are no plans for sperm or egg donation, no plans for pregnancy, and voluntary use of effective contraceptive measures.
Who cannot join
- Renal biopsy pathology indicates tubular atrophy or interstitial fibrosis exceeding 50%.
- Renal biopsy pathology indicates crescent formation in more than 50% of glomeruli, or clinical presentation suggests the possibility of rapidly progressive glomerulonephritis (RPGN) (eGFR decline ≥50% within 3 months).
- Participants were evaluated by the investigator as having IgAN, C3G, IC-MPGN, or PMN secondary to conditions such as infection, autoimmune diseases, or monoclonal immunoglobulin-associated diseases.
- Participants were evaluated by the investigator as having other systemic diseases or other kidney diseases that could lead to proteinuria, such as diabetic nephropathy, IgA vasculitis, lupus nephritis, or ANCA-associated small vessel vasculitis.
- Participants were determined to have acute kidney injury (AKI) within 30 days prior to screening and before administration of the study drug.
- Participants were on dialysis at the time of screening or might require dialysis treatment during the study.
Show all 22Show fewer
- Participants had received B cell-targeting biologics, such as rituximab or ocrelizumab, within 180 days prior to the first administration of the study drug.
- Participants had used other biologics, such as infliximab or eculizumab, within 90 days prior to the first administration of the study drug.
- Participants who received sodium-glucose co-transporter 2 inhibitors (SGLT2i) within 90 days prior to the first administration of the study drug are excluded, except for those who had been on stable SGLT2i therapy for 90 days or more prior to the first administration and continued stable use during the study.
- Participants who received mineralocorticoid receptor antagonists (MRA), such as spironolactone, eplerenone, or finerenone, within 30 days prior to the first administration of the study drug are excluded, except for those who had been on stable MRA therapy for 90 days or more prior to the first administration and continued stable use during the study.
- Participants with a history of kidney transplantation, organ transplantation, or hematopoietic stem cell transplantation are excluded.
- Participants with any history of malignancy within 5 years prior to screening are excluded, except for those who have been cured (such as basal cell carcinoma, cutaneous squamous cell carcinoma, low-risk/very low-risk localized prostate cancer, papillary thyroid carcinoma, etc.) or have undergone radical resection of carcinoma in situ (such as ductal carcinoma in situ of the breast, cervical carcinoma in situ, etc.).
- History of active tuberculosis within 1 year prior to screening, or deemed by the investigator to have active tuberculosis at screening.
- Participants with chronic recurrent infections within 1 year prior to screening, such as liver abscess, chronic pyelonephritis, etc.
- Surgery requiring general anesthesia or hospitalization for more than 1 day within 30 days prior to screening or planned during the trial.
- Administration of live attenuated vaccines other than those allowed in the protocol within 30 days prior to screening or planned during the study.
- Clinically significant infection requiring systemic anti-infective treatment within 30 days prior to the first administration of the investigational product.
- History of recurrent invasive infections with encapsulated bacteria (e.g., Neisseria meningitidis and Streptococcus pneumoniae).
- History of severe drug allergy, or allergic reaction to oligonucleotides or N-acetylgalactosamine (GalNAc).
- Poorly controlled type 1 or type 2 diabetes, defined as baseline glycated hemoglobin (HbA1c) ≥7.0%.
- Poorly controlled hypertension, defined as baseline seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg.
- History of renal artery stenosis, chronic hyperkalemia, or other contraindications to RAS inhibitors (RASi).
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
Pei Chen, 01083572211, kyc@bjmu.edu.cn
About this study
Official title: A Phase II Clinical Study Evaluating the Efficacy and Safety of QLS7305 in Patients With Primary IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and Primary Membranous Nephropathy (PMN)
QLS7305 injection is a chemically synthesized double-stranded small interfering RNA (siRNA) targeting complement C3, covalently linked to a ligand containing N-acetylgalactosamine (GalNAc) residues. After subcutaneous (SC) administration, it can inhibit C3 synthesis through the RNA interference (RNAi) mechanism, reduce circulating C3 protein levels, decrease the generation of complement-activated C5 convertase, and inhibit complement pathway activation. It is expected to become an effective treatment for complement-mediated kidney diseases and hematological disorders.
- Conditions
- IgAN - IgA Nephropathy, Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), C3 Glomerulopathy (C3G), Primary Membranous Nephropathy
- Being tested
- QLS7305 Injection
- Keywords
- IC⁃MPGN, C3G, PMN, IgAN
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS7305 InjectionDrug
Route of administration: subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: IgAN, QLS7305 injection 100 mg on D1 and D85 | Experimental | Not described Receives: Drug: QLS7305 Injection |
| Cohort 2: IgAN, QLS7305 injection 200 mg on D1 and D85 | Experimental | Not described Receives: Drug: QLS7305 Injection |
| Cohort 3: C3G/IC-MPGN/PMN, QLS7305 injection 200 mg on D1 and D85 | Experimental | Not described Receives: Drug: QLS7305 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the 24h-UPCR at week 12
Measured: Baseline and day 85
Secondary outcomes (4)
Change from Baseline in the 24h-UPCR at week 24/36
Measured: Baseline, day 169 and 253
Change from Baseline in the 24h-UACR at week 12/24/36
Measured: Baseline, day 85, 169 and 253
Change from Baseline in the Scr at each visit
Measured: Baseline, day 15, 29, 57, 85, 99, 113, 141, 169, 197, 225 and 253
Number of Participants with Adverse Events as Assessed by CTCAE v6.0
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start10 Aug 2026 (estimated)
- Primary completion10 Aug 2028 (estimated)
- Study completion11 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgAN - IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730632
- Sponsor's protocol ID
- QLS7305-201
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study Evaluating the Efficacy and Safety of QLS7305 in Patients With Primary IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and Primary Membranous Nephropathy (PMN)
- ClinicalTrials.gov ID
- NCT07730632
- Acronym / sponsor ID
- QLS7305-201
- Conditions
- IgAN - IgA Nephropathy, Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), C3 Glomerulopathy (C3G), Primary Membranous Nephropathy
- Keywords
- IC⁃MPGN, C3G, PMN, IgAN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 10 Aug 2028 (estimated)
- Study completion
- 11 Aug 2028 (estimated)
- First posted
- 28 Jul 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.
QLS7305 injection is a chemically synthesized double-stranded small interfering RNA (siRNA) targeting complement C3, covalently linked to a ligand containing N-acetylgalactosamine (GalNAc) residues. After subcutaneous (SC) administration, it can inhibit C3 synthesis through the RNA interference (RNAi) mechanism, reduce circulating C3 protein levels, decrease the generation of complement-activated C5 convertase, and inhibit complement pathway activation. It is expected to become an effective treatment for complement-mediated kidney diseases and hematological disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: IgAN, QLS7305 injection 100 mg on D1 and D85 | Experimental | Drug: QLS7305 Injection |
| Cohort 2: IgAN, QLS7305 injection 200 mg on D1 and D85 | Experimental | Drug: QLS7305 Injection |
| Cohort 3: C3G/IC-MPGN/PMN, QLS7305 injection 200 mg on D1 and D85 | Experimental | Drug: QLS7305 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body weight ≥ 40 kg, Body Mass Index (BMI) < 32.5 kg/m²
- Within the five years prior to screening, patients must have been diagnosed with primary IgAN or PMN through renal biopsy, or within one year prior to screening, diagnosed with C3G or IC-MPGN through renal biopsy, accompanied by glomerular C3 deposition; if a renal biopsy has not been previously performed, a renal biopsy must be conducted during the screening period to confirm eligibility criteria.
- Participants with IgAN and C3G/IC-MPGN: During the screening period, morning urine UPCR or 24-hour UPCR ≥0.75 g/g or 24-hour UP ≥1 g/day, with the average of two 24-hour UPCR measurements at baseline ≥0.75 g/g; PMN participants: During the screening period, morning urine or 24-hour UP ≥3.5 g/day, with the average of two 24-hour UP measurements at baseline ≥3.5 g/day.
- During the screening and baseline periods, eGFR ≥ 30 ml·min-¹·1.73 m-² (using the CKD-EPI formula)
- Prior to the first administration, the patient should have received the maximum tolerated dose or the maximum dose recommended in the instructions of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) for at least 12 weeks, and the dose of the ACEi or ARB should have been stable for at least 4 weeks before the first administration.
Key exclusion criteria (22 listed)
- Renal biopsy pathology indicates tubular atrophy or interstitial fibrosis exceeding 50%.
- Renal biopsy pathology indicates crescent formation in more than 50% of glomeruli, or clinical presentation suggests the possibility of rapidly progressive glomerulonephritis (RPGN) (eGFR decline ≥50% within 3 months).
- Participants were evaluated by the investigator as having IgAN, C3G, IC-MPGN, or PMN secondary to conditions such as infection, autoimmune diseases, or monoclonal immunoglobulin-associated diseases.
- Participants were evaluated by the investigator as having other systemic diseases or other kidney diseases that could lead to proteinuria, such as diabetic nephropathy, IgA vasculitis, lupus nephritis, or ANCA-associated small vessel vasculitis.
- Participants were determined to have acute kidney injury (AKI) within 30 days prior to screening and before administration of the study drug.
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 |
|---|---|---|
| QLS7305 InjectionRoute of administration: subcutaneous injection | Drug | Cohort 1: IgAN, QLS7305 injection 100 mg on D1 and D85, Cohort 2: IgAN, QLS7305 injection 200 mg on D1 and D85, Cohort 3: C3G/IC-MPGN/PMN, QLS7305 injection 200 mg on D1 and D85 |
Primary outcome
Change from Baseline in the 24h-UPCR at week 12
Time frame: Baseline and day 85
4 secondary outcomes
Change from Baseline in the 24h-UPCR at week 24/36
Time frame: Baseline, day 169 and 253
Change from Baseline in the 24h-UACR at week 12/24/36
Time frame: Baseline, day 85, 169 and 253
Change from Baseline in the Scr at each visit
Time frame: Baseline, day 15, 29, 57, 85, 99, 113, 141, 169, 197, 225 and 253
Number of Participants with Adverse Events as Assessed by CTCAE v6.0
Time frame: Up to Week 48
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 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for IgAN - IgA Nephropathy
RecruitingPhase 2
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
Immunoglobulin A Nephropathy (IgAN)
Not yet recruitingPhase 1
IBI3034 Study in Healthy Adults and Patients With Primary IgA Nephropathy
IgA Nephropathy (IgAN)
RecruitingPhase 2
Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
IgAN, C3G
Enrolling by invitationObservational study
Mediators of Loin Pain in IgA Nephropathy
IgA Nephropathy (IgAN)
Not yet recruitingPhase 2
A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
Immunoglobulin A 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.
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 QLS7305 Injection in people with IgAN - IgA Nephropathy and Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), run by Qilu Pharmaceutical Co., Ltd. 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 7 inclusion and 22 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 Jul 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 Chuan Tian (15801230857, chuan2.tian@qilu-pharma.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 the 24h-UPCR at week 12 (time frame: Baseline and day 85). 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 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.