Prevention trial for IgA Nephropathy (IgAN)
Official title Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy
ClinicalTrials.gov ID: NCT07604311
What this study is testing
What is NEFECON?
NEFECON is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for iga nephropathy (igan).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- Systemic diseases that may cause mesangial immunoglobulin A deposition, including but not limited to IgA vasculitis nephritis, systemic lupus...
- 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...
See the full eligibility 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;
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.