Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
(Nefigard Trial)
Recruiting in Palo Alto (17 mi)
+141 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Calliditas Therapeutics AB
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial tests Nefecon, a daily oral medication, for patients with primary IgAN who are not improving with standard treatments. The drug aims to reduce kidney inflammation and prevent further damage.
Eligibility Criteria
Inclusion Criteria
Stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or Maximum Tolerated Dose (MTD) according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guidelines
Urine protein creatinine ratio ≥1 g/24hr
eGFR ≥35 mL/min per 1.73 m2 and ≤90 mL/min per 1.73 m2 using the Chronic Kidney Diseae Epidemiology Collaboration (CKD-EPI) formula
See 3 more
Treatment Details
Interventions
- Nefecon (Immunosuppressant)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NefeconExperimental Treatment1 Intervention
Nefecon 16 mg once daily by mouth for 9 months.
Group II: Placebo oral capsulePlacebo Group1 Intervention
Placebo oral capsule once daily by mouth for 9 months.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern University the Feinberg School of Medicine, 633 North St. ClairChicago, IL
Northshore University Health System, 2650 Ridge Av.Evanston, IL
Vancouver Coastal Health Authority, Gordon and Leslie Diamond Health Care Centre, 5 th floor, Diamond BuildingVancouver, Canada
University of Minnesota, 717 Delaware St. SEMinneapolis, MN
More Trial Locations
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Who Is Running the Clinical Trial?
Calliditas Therapeutics ABLead Sponsor