Phase 3 N=364 Randomized Quadruple-blind Treatment

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

Primary IgA Nephropathy

Bottom Line

View on ClinicalTrials.gov: NCT03643965 ↗

Enrolled (actual)

364

Serious AEs

7.4%

Results posted

Dec 2024

Primary outcome: Primary: Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline — 0.69; 0.95 ratio — p=0.0003

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Nefecon (Drug); Placebo oral capsule (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Calliditas Therapeutics AB
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline	0.69; 0.95	0.0003 sig
PRIMARY Part B: Time-weighted Average of Estimated Glomerular Filtration Rate (eGFR)	0.96; 0.87	<0.0001 sig
SECONDARY Part A: Ratio of eGFR at 9 Months	1.00; 0.93	0.0014 sig
SECONDARY Part A: Ratio of eGFR at 12 Months	0.97; 0.91	0.0106 sig
SECONDARY Part A: Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months	0.64; 0.93	0.0005 sig
SECONDARY Part B: Time to 30% Reduction in eGFR	21; 39	0.0028 sig
SECONDARY Part B: Time to Receiving Rescue Medication.	15; 20	0.2647
SECONDARY Part B: Ratio of UPCR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months	0.60; 1.01	<0.0001 sig
SECONDARY Part B: Ratio of UACR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months	0.52; 0.96	<0.0001 sig
SECONDARY Part B: Ratio of eGFR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months	0.93; 0.84	<0.0001 sig
SECONDARY Part B: Proportion of Patients Without Microhematuria	94; 59	0.0001 sig
SECONDARY Part B: Short Form 36 (SF-36) Quality of Life Assessment at 9 Months.	54.353; 54.659; 47.058; 48.014; 49.564; 49.760	—
SECONDARY Part B: Short Form 36 (SF-36) Quality of Life Assessment at 24 Months.	53.385; 53.208; 47.038; 47.214; 51.246; 49.743	—

Summary

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Eligibility Criteria

Inclusion Criteria

Female or male patients ≥18 years
Biopsy-verified IgA nephropathy
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
Willing and able to give informed consent

Exclusion Criteria

Systemic diseases that may cause mesangial IgA deposition.
Patients who have undergone a kidney transplant.
Patients with acute or chronic infectious disease including hepatitis, tuberculosis, 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 (NCT03643965). 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.