Phase 3 N=119 Treatment

Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)

Primary IgA Nephropathy

Bottom Line

View on ClinicalTrials.gov: NCT04541043 ↗

Enrolled (actual)

119

Serious AEs

8.4%

Results posted

Jan 2025

Primary outcome: Primary: Ratio of Urine Protein to Creatine Ratio (UPCR) at 9 Months Compared to Baseline — 0.67; 0.69 ratio

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Nefecon 16mg daily (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Calliditas Therapeutics AB
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Ratio of Urine Protein to Creatine Ratio (UPCR) at 9 Months Compared to Baseline	0.67; 0.69	—
PRIMARY Ratio of Estimated Glomerular Filtration Rate (eGFR) at 9 Months Compared to Baseline	0.97; 0.97	—
SECONDARY Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months Compared to Baseline	0.60; 0.65	—
SECONDARY Change From Baseline Short Form 36 (SF-36) Quality of Life Assessment at 12 Months	-4.518; -3.756; -4.290; -3.301; -2.282; -1.061	—
SECONDARY Number of Patients With Microhematuria at 9 Months Compared to Baseline	10; 17	—
SECONDARY Number of Patients Receiving Rescue Treatment	1; 0	—
SECONDARY Proportion of Patients on Dialysis, Undergoing Kidney Transplantation, or With eGFR <15 mL/Min Per 1.73 m2	2; 0	—
SECONDARY Change From Baseline Cortisol Suppression at 9 Months	-24.122; -32.126	—
SECONDARY Change From Baseline Cortisol Suppression at 12 Months	-7.660; -11.954	—

Summary

This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef-301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon.

Eligibility Criteria

Inclusion Criteria

Patients that completed study Nef-301
On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or maximum tolerated dose according to the 2012 KDIGO guidelines
Willing and able to provide written informed consent.
UPCR equal to or more than 0.8 g/gram
eGFR equal to or more than 30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Exclusion Criteria

Systemic diseases that may cause mesangial IgA deposition.
Patients who have undergone a kidney transplant;
Patients with presence of other glomerulopathies and/or nephrotic syndrome
Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections;
Patients with liver cirrhosis, as assessed by the Investigator;
Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled
Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator.
Patients with diagnosed malignancy within the past 5 years.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04541043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.