Nefecon as a maintenance therapy to prevent relapse in IgA nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 trial examines if Nefecon 8 mg daily, given for 15 months as maintenance, reduces relapse risk in patients whose proteinuria remitted after at least 9 months of Nefecon 16 mg daily. Participants must have had proteinuria ≥1 g/day before starting Nefecon and meet specific renal function and stable concomitant therapy criteria. The study compares Nefecon with placebo in adults with biopsy-confirmed IgA nephropathy who previously achieved remission. Safety and efficacy will be monitored throughout the treatment period and during follow-up. The goal is to determine if ongoing Nefecon can sustain remission and slow disease progression while ensuring tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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.;
* 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.

Where it's running

• Nanfang hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Fan Fan Hou
• Email: ffhouguangzhou@163.com
• Phone: +8620 61641591

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JADE101 in IgA Nephropathy (phase 3, blinded)

  This phase 3 study tests whether JADE101 helps adults with IgA nephropathy more than a placebo.

  Recruiting at 4 sites Phase 3 Jade Biosciences, Inc. · Arvada, Colorado and 3 other locations · NCT07902817

• Personalized IgA Nephropathy treatment guided by Gd-IgA1 monitoring

  This study tests whether regularly checking a biomarker called Gd-IgA1 to guide treatment with Nefecon or telitacicept helps people with IgA nephropathy or related nephritis respond better.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07822100

• Long-term safety and effectiveness of HSK39297 tablets in IgA nephropathy patients who completed prior study

  This phase 2 trial tests whether taking HSK39297 once daily for IgA nephropathy is safe over the long term and helps reduce protein in the urine for patients who completed a previous study and meet criteria.

  Recruiting Phase 2 Haisco Pharmaceutical Group Co., Ltd. · Beijing and 1 other locations · NCT07616700

• Everest001: a medicine for certain kidney diseases to see if it helps adults

  This study tests EVER001 in adults with FSGS, MCD, or IgA nephropathy to see if it can help reduce protein in the urine and improve kidney function.

  Recruiting at 2 sites Phase 2 Everest Medicines (China) Co.,Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07614477

• CD19/BCMA UCART for B cell–related autoimmune diseases

  This early-stage study tests QT-219CX, a universal allogeneic CAR-T cell therapy that targets CD19 and BCMA, in people with refractory B-cell–related autoimmune diseases to see if it can be given safely and provide early signs of benefit.

  Recruiting Early Phase 1 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07586267

• Allogeneic CD19/BCMA CAR‑T for B‑cell autoimmune disease

  This Phase 1 study will test a donor-derived CAR‑T therapy that targets CD19 and BCMA to try to reset the immune system in people with refractory B‑cell autoimmune diseases such as SLE, IgA nephropathy, systemic sclerosis, and resistant nephrotic syndrome.

  Recruiting Early Phase 1 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07507201

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.