Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

(Nefigard Trial)

Recruiting at141 trial 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.

Research Team

Krassimir Mitchev, MD

Principal Investigator

Calliditas AB

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

Treatment Details

Interventions

• Nefecon (Immunosuppressant)

Participant Groups

Group I: Nefecon Experimental Treatment 1 Intervention

Nefecon 16 mg once daily by mouth for 9 months.

Group II: Placebo oral capsule Placebo Group 1 Intervention

Placebo oral capsule once daily by mouth for 9 months.

Who Is Running the Clinical Trial?

Calliditas Therapeutics AB

Lead Sponsor

Trials

11

Recruited

1,200+