This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients who have completed Nef-301 and continue to be treated with a stable dose of Renin-angiotensin system (RAS) inhibitor therapy (Angiotensin-converting enzyme inhibitors (ACEIs) and/or Angiotensin II type I receptor blockers (ARBs).
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients with Immunoglobulin A nephropathy (IgAN) who have completed Nef 301 study and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). During Study open-label extension (OLE) study, patients will receive Nefecon for a 9-month period. The patient will come for a follow-up visit at 12 months after first dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Nefecon is taken orally as capsules once daily for 9 months.
Peking University First Hospital
Beijing, Beijing Municipality, China
Change in urine protein to creatinine ratio (UPCR) after 9 months
The outcome is measured as urine protein to creatinine ratio (UPCR) based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline.following the first dose of Nefecon compared to baseline.
Time frame: 9 months
Change in estimated glomerular filtration rate(eGFR) at 9 months
The outcome is measured as change in eGFR at 9 months following the first dose of Nefecon compared to baseline.
Time frame: 9 months
The incidence of treatment emergent adverse events
Adverse event data collection
Time frame: from enrollment up to 12 months
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