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New hope for kidney patients: drug aims to prevent relapse
NCT ID NCT07604311
First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This study tests whether a 15-month course of Nefecon can prevent proteinuria relapse in 288 adults with IgA nephropathy who have already achieved remission. Participants must have completed prior Nefecon therapy and have stable kidney function. The goal is to see if maintenance treatment can keep the disease under control and slow progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nefecon (a targeted corticosteroid)
- What this could lead to
- If successful, this could offer a maintenance therapy to keep IgA nephropathy in remission and delay kidney disease progression.
- What could go wrong
- This is a phase 4 trial, but it is not yet recruiting. The benefit is only for patients already in remission, and long-term steroid use carries risks like infection or metabolic effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 288 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nanfang hospital, Southern Medical University
RECRUITINGGuangzhou, Guangdong, 510515, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Blood test may help doctors Fine-Tune kidney disease therapy
- 10,000 kidneys under the microscope: registry maps IgA Nephropathy's course
- Can a daily pill protect kidneys in IgA nephropathy? MRI study puts atrasentan to the test
- Can AI learn to spot kidney disease in biopsy images?
- Microbes in the mouth and gut may hold clues to a common kidney disease
- Can a single injection drug calm the immune attack on kidneys?