Primary IgA NephropathyPhase 2NCT06982040
Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy
A Phase 2 study testing NTQ5082 capsules 100 mg, NTQ5082 capsules 200 mg and NTQ5082 capsules 300 mg in people with Primary IgA Nephropathy, run by Nanjing Chia-tai Tianqing Pharmaceutical.
Trial summary
NTQ5082 is a small molecule inhibitor of complement factor B (CFB) that inhibits the enzymatic activity of CFB, thereby blocking the alternative pathway of the complement activation cascade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary IgA Nephropathy
- What is being tested?
- NTQ5082 capsules 100 mg, NTQ5082 capsules 200 mg and NTQ5082 capsules 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Sep 2026
- 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
- Age ≥18 years, male or female.
- Body weight ≥40 kg, BMI between 15 to 38 kg/m².
- Diagnosis of primary IgA nephropathy confirmed by renal biopsy within 8 years before screening or during screening.
- 24-hour urine protein excretion (24h-UPE) ≥0.75 g/24h, or first morning void (FMV) urine protein-to-creatinine ratio (UPCR) ≥0.8 g/g.
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m².
- Previously vaccinated with ACYW135 meningococcal polysaccharide vaccine and pneumococcal vaccine.
- Received renin-angiotensin system (RAS) inhibitor therapy for at least 12 weeks prior to randomization, with stable treatment at the maximum recommended dose or maximum tolerated dose of RAS inhibitors for at least 4 weeks prior to randomization.
- Agreement to use at least one effective contraceptive method with partners during sexual activity from signing the informed consent form until 4 weeks after the last administration of the investigational product, and refrain from sperm/egg donation during this period.
Who cannot join
- Receipt of aldosterone receptor antagonists, renin inhibitors, or medications significantly affecting creatinine levels within 4 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
- Continuous use of systemic corticosteroids, immunosuppressants/modulators, or Chinese herbal medicines with immunosuppressive effects within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
- Treatment with biological agents or complement pathway inhibitors (other than the study drug) within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
- History of gastrointestinal surgery potentially altering drug absorption/distribution/metabolism/excretion, severe gastrointestinal disorders, or conditions causing dysphagia/recurrent vomiting that may interfere with oral medication intake.
- Major trauma/surgery within 12 weeks before screening or planned major surgery during the study.
- Previous bone marrow/hematopoietic stem cell transplantation or solid organ transplantation (e.g., heart, lung, kidney, liver).
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- Known/suspected hereditary complement deficiency, or diagnosed primary/severe secondary immunodeficiency.
- Poorly controlled blood pressure as assessed by the investigator.
- Poorly controlled blood glucose as assessed by the investigator.
- Presence of nephrotic syndrome, rapidly progressive glomerulonephritis, renal pathology showing >50% glomerular crescents, or >50% tubular atrophy-interstitial fibrosis.
- Participation in other interventional clinical trials with pharmacological/device interventions within 4 weeks before screening.
- Pregnant/lactating women or those planning pregnancy during the study
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of NTQ5082 Capsules in the Treatment of Patients With Primary IgA Nephropathy
NTQ5082 is a small molecule inhibitor of complement factor B (CFB) that inhibits the enzymatic activity of CFB, thereby blocking the alternative pathway of the complement activation cascade. It is being clinically developed for the treatment of primary IgA nephropathy The main objectives of the study were to assess the efficacy and safety of NTQ5082 capsules in the treatment of patients with primary IgA nephropathy.
- Conditions
- Primary IgA Nephropathy
- Being tested
- NTQ5082 capsules 100 mg, NTQ5082 capsules 200 mg, NTQ5082 capsules 300 mg, 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.
NTQ5082 capsules 100 mgDrug
NTQ5082 capsules 100 mg
NTQ5082 capsules 200 mgDrug
NTQ5082 capsules 200 mg
NTQ5082 capsules 300 mgDrug
NTQ5082 capsules 300 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NTQ5082 capsules 100 mg | Experimental | NTQ5082 capsules 100 mg Receives: Drug: NTQ5082 capsules 100 mg |
| NTQ5082 capsules 200 mg | Experimental | NTQ5082 capsules 200 mg Receives: Drug: NTQ5082 capsules 200 mg |
| NTQ5082 capsules 300 mg | Experimental | NTQ5082 capsules 300 mg Receives: Drug: NTQ5082 capsules 300 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The log-transformed ratio of 24-hour urine protein-to-creatinine ratio (24h-UPCR) compared to baseline after 12 weeks of treatment.
Measured: Week 12
Secondary outcomes (6)
The log-transformed ratio of 24-hour urine protein-to-creatinine ratio (24h-UPCR) compared to baseline during treatment period except week 12
Measured: From week 1 to week 24
The change in estimated glomerular filtration rate(eGFR) compared to baseline during treatment period.
Measured: From week 1 to week 24
The change in serum creatinine (SCr) compared to baseline during treatment period.
Measured: From week 1 to week 24
The log-transformed ratios of first morning void (FMV) UPCR and UACR compared to baseline during treatment period
Measured: From week 1 to week 24
The change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale score compared to baseline during the treatment period.
0-52,the higher the score, the better the QOL.
Measured: From week 1 to week 24
Incidence and severity of adverse events [safety and tolerability]
Adverse events were based on clinically significant laboratory tests, vital signs, physical examination, and 12-lead electrocardiography
Measured: 28weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study startMay 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Nanjing Chia-tai Tianqing PharmaceuticalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982040
- Sponsor's protocol ID
- NTQ5082-202
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of NTQ5082 Capsules in the Treatment of Patients With Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT06982040
- Acronym / sponsor ID
- NTQ5082-202
- Conditions
- Primary IgA Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanjing Chia-tai Tianqing PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 May 2025 (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.
NTQ5082 is a small molecule inhibitor of complement factor B (CFB) that inhibits the enzymatic activity of CFB, thereby blocking the alternative pathway of the complement activation cascade. It is being clinically developed for the treatment of primary IgA nephropathy The main objectives of the study were to assess the efficacy and safety of NTQ5082 capsules in the treatment of patients with primary IgA nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NTQ5082 capsules 100 mg | Experimental | Drug: NTQ5082 capsules 100 mgNTQ5082 capsules 100 mg |
| NTQ5082 capsules 200 mg | Experimental | Drug: NTQ5082 capsules 200 mgNTQ5082 capsules 200 mg |
| NTQ5082 capsules 300 mg | Experimental | Drug: NTQ5082 capsules 300 mgNTQ5082 capsules 300 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years, male or female.
- Body weight ≥40 kg, BMI between 15 to 38 kg/m².
- Diagnosis of primary IgA nephropathy confirmed by renal biopsy within 8 years before screening or during screening.
- 24-hour urine protein excretion (24h-UPE) ≥0.75 g/24h, or first morning void (FMV) urine protein-to-creatinine ratio (UPCR) ≥0.8 g/g.
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m².
Key exclusion criteria (12 listed)
- Receipt of aldosterone receptor antagonists, renin inhibitors, or medications significantly affecting creatinine levels within 4 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
- Continuous use of systemic corticosteroids, immunosuppressants/modulators, or Chinese herbal medicines with immunosuppressive effects within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
- Treatment with biological agents or complement pathway inhibitors (other than the study drug) within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
- History of gastrointestinal surgery potentially altering drug absorption/distribution/metabolism/excretion, severe gastrointestinal disorders, or conditions causing dysphagia/recurrent vomiting that may interfere with oral medication intake.
- Major trauma/surgery within 12 weeks before screening or planned major surgery during the study.
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 |
|---|---|---|
| NTQ5082 capsules 100 mgNTQ5082 capsules 100 mg | Drug | NTQ5082 capsules 100 mg |
| NTQ5082 capsules 200 mgNTQ5082 capsules 200 mg | Drug | NTQ5082 capsules 200 mg |
| NTQ5082 capsules 300 mgNTQ5082 capsules 300 mg | Drug | NTQ5082 capsules 300 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
The log-transformed ratio of 24-hour urine protein-to-creatinine ratio (24h-UPCR) compared to baseline after 12 weeks of treatment.
Time frame: Week 12
6 secondary outcomes
The log-transformed ratio of 24-hour urine protein-to-creatinine ratio (24h-UPCR) compared to baseline during treatment period except week 12
Time frame: From week 1 to week 24
The change in estimated glomerular filtration rate(eGFR) compared to baseline during treatment period.
Time frame: From week 1 to week 24
The change in serum creatinine (SCr) compared to baseline during treatment period.
Time frame: From week 1 to week 24
The log-transformed ratios of first morning void (FMV) UPCR and UACR compared to baseline during treatment period
Time frame: From week 1 to week 24
The change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale score compared to baseline during the treatment period.
Time frame: From week 1 to week 24
Incidence and severity of adverse events [safety and tolerability]
Time frame: 28weeks
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 21 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NTQ5082 capsules 100 mg, NTQ5082 capsules 200 mg and NTQ5082 capsules 300 mg in people with Primary IgA Nephropathy, run by Nanjing Chia-tai Tianqing Pharmaceutical.
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 12 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 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The log-transformed ratio of 24-hour urine protein-to-creatinine ratio (24h-UPCR) compared to baseline after 12 weeks of treatment. (time frame: Week 12). 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 21 May 2025.