IgA Nephropathy (IgAN)Phase 4NeFRINNCT07604311
Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy
A Phase 4 study testing NEFECON in people with IgA Nephropathy (IgAN), run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
IgA nephropathy (IgAN) is a chronic progressive kidney disease, and long-term control of proteinuria and prevention of relapse are crucial for delaying disease progression. Patients with IgAN who achieve proteinuria remission after receiving Nefecon for 9 months or longer still face the risk of proteinuria relapse… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- NEFECON
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2026to 31 Dec 2028
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed primary IgAN with biopsy verification;
- Female or male participants ≥18 years of age;
- Completion of ≥9 months of Nefecon 16 mg QD at the baseline visit;
- Proteinuria ≥ 1g/d prior to initiation of Nefecon;
- Proteinuria<0.5 g/day (or UPCR <0.5 g/g) at screening and randomization visit;
- eGFR ≥30 ml/min/1.73m² at screening;
- On stable treatment with supportive treatment (including RAASi, SGLT2i, ERA) for at least 1 month prior to the baseline visit;
Who cannot join
- Systemic diseases that may cause mesangial immunoglobulin A deposition, including but not limited to IgA vasculitis nephritis, systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis, and others;
- Type 1 or type 2 diabetes mellitus;
- Presence of primary or secondary glomerulopathies (e.g., membranous nephropathy, focal segmental glomerulosclerosis, C3 glomerulopathy and others);
- Active infection, severe hepatic impairment (Child-Pugh Class C), congestive heart failure, and malignant tumor within the past 5 years;
- On current or planned dialysis or kidney transplantation;
- Participants who have been treated with systemic glucocorticoids and immunosuppressive agents within the past 3 months, including mycophenolate mofetil, hydroxychloroquine, cyclophosphamide, azathioprine, leflunomide, calcineurin inhibitors, and Chinese traditional medicines with immunosuppressive effects (such as Tripterygium wilfordii, Sinomenium acutum, Tripterygium Glycosides Tablets, Kunxian Capsules, Kunming Shanhaitang Tablets, etc.); treatment with B-cell targeted biological agents (such as telitacicept and sibeprenlimab, etc.); complement pathway inhibitors, etc.;
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- Poorly controlled hypertension (resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
- Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4 within the past 1 month, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, or cyclosporine;
- Females who are pregnant, breastfeeding, or planning to become pregnant in the trial period.
- Any other conditions that, in the investigator's judgment, make the patient ineligible for this clinical study.
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, 1 recruiting
- Recruiting
Nanfang hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Fan Fan Hou, +8620 61641591, ffhouguangzhou@163.com
About this study
Official title: Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy: a Randomized, Double-blinded, Placebo-Controlled Trial
IgA nephropathy (IgAN) is a chronic progressive kidney disease, and long-term control of proteinuria and prevention of relapse are crucial for delaying disease progression. Patients with IgAN who achieve proteinuria remission after receiving Nefecon for 9 months or longer still face the risk of proteinuria relapse after treatment discontinuation. This study is to evaluate the efficacy and safety of Nefecon 8 mg treatment for 15 months as a maintenance therapy to reduce the risk of IgAN relapse in proteinuria-remitted patients.
- Conditions
- IgA Nephropathy (IgAN)
- Being tested
- NEFECON, 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.
NEFECONDrug
NEFECON 8mg once daily by mouth for 15 months
PlaceboDrug
Placebo oral capsule once daily by mouth for 15 months
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo Receives: Drug: Placebo |
| Treatment arm | Experimental | NEFECON Receives: Drug: NEFECON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first composite disease relapse
either a ≥100% increase in UPCR and an absolute UPCR ≥0.5 g/g, or a ≥30% decline in eGFR from randomization
Measured: 15 months
Secondary outcomes (6)
eGFR slope
eGFR slope from baseline to Month 15
Measured: 15 months
The proportion of patients with UPCR ≥0.5 g/g
The proportion of patients with sustained UPCR ≥0.5 g/g
Measured: 15 months
The proportion of patients with UPCR ≥1 g/g
The proportion of patients with sustained UPCR ≥1 g/g
Measured: 15 months
Changes in UPCR and 24-hour urinary protein
Changes in UPCR and 24-hour urinary protein from baseline to Months 3, 6, 9, 12, and 15
Measured: 3, 6, 9, 12, and 15 Months
Major adverse kidney events
The proportion of patients with the first occurrence of major adverse kidney events within 15 months, defined as the occurrence of any one of the following: eGFR ≤15 ml/min/1.73m², maintenance dialysis, kidney transplantation, ≥30% decrease in eGFR, or kidney-related death
Measured: 15 months
All-cause mortality
All-cause mortality
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start23 Jun 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion31 Dec 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.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604311
- Sponsor's protocol ID
- NFEC-2026-268
- Acronym
- NeFRIN
- Status last verified
- Aug 2026
- First submitted
- 18 May 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy: a Randomized, Double-blinded, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07604311
- Acronym / sponsor ID
- NeFRIN / NFEC-2026-268
- Conditions
- IgA Nephropathy (IgAN)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 May 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.
IgA nephropathy (IgAN) is a chronic progressive kidney disease, and long-term control of proteinuria and prevention of relapse are crucial for delaying disease progression. Patients with IgAN who achieve proteinuria remission after receiving Nefecon for 9 months or longer still face the risk of proteinuria relapse after treatment discontinuation. This study is to evaluate the efficacy and safety of Nefecon 8 mg treatment for 15 months as a maintenance therapy to reduce the risk of IgAN relapse in proteinuria-remitted patients.
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 |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboPlacebo |
| Treatment arm | Experimental | Drug: NEFECONNEFECON |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed primary IgAN with biopsy verification;
- Female or male participants ≥18 years of age;
- Completion of ≥9 months of Nefecon 16 mg QD at the baseline visit;
- Proteinuria ≥ 1g/d prior to initiation of Nefecon;
- Proteinuria<0.5 g/day (or UPCR <0.5 g/g) at screening and randomization visit;
Key exclusion criteria (10 listed)
- Systemic diseases that may cause mesangial immunoglobulin A deposition, including but not limited to IgA vasculitis nephritis, systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis, and others;
- Type 1 or type 2 diabetes mellitus;
- Presence of primary or secondary glomerulopathies (e.g., membranous nephropathy, focal segmental glomerulosclerosis, C3 glomerulopathy and others);
- Active infection, severe hepatic impairment (Child-Pugh Class C), congestive heart failure, and malignant tumor within the past 5 years;
- On current or planned dialysis or kidney transplantation;
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 |
|---|---|---|
| NEFECONNEFECON 8mg once daily by mouth for 15 months | Drug | Treatment arm |
| PlaceboPlacebo oral capsule once daily by mouth for 15 months | Drug | Control |
Primary outcome
Time to first composite disease relapse
Time frame: 15 months
either a ≥100% increase in UPCR and an absolute UPCR ≥0.5 g/g, or a ≥30% decline in eGFR from randomization
6 secondary outcomes
eGFR slope
Time frame: 15 months
The proportion of patients with UPCR ≥0.5 g/g
Time frame: 15 months
The proportion of patients with UPCR ≥1 g/g
Time frame: 15 months
Changes in UPCR and 24-hour urinary protein
Time frame: 3, 6, 9, 12, and 15 Months
Major adverse kidney events
Time frame: 15 months
All-cause mortality
Time frame: 15 months
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 2 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NEFECON in people with IgA Nephropathy (IgAN), run by Nanfang Hospital, Southern Medical University 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 10 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: looking for participants now, as of the sponsor's last update on 2 Sep 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Fan Fan Hou (+8620 61641591, ffhouguangzhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first composite disease relapse (time frame: 15 months). 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 2 Sep 2026.