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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT03643965
• Date of registration: 08/08/2018
• Prospective Registration: Yes
• Primary sponsor: Calliditas Therapeutics AB
• Public title: Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy Nefigard
• Scientific title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)
• Date of first enrolment: September 5, 2018
• Target sample size: 365
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03643965
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belarus, Belgium, Canada, Czechia, Finland, France, Germany, Greece, Italy, Korea, Republic of, Poland, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Krassimir Mitchev, MD
• Affiliation: Calliditas AB

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Female or male patients =18 years

2. Biopsy-verified IgA nephropathy

3. 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

4. Urine protein creatinine ratio =1 g/24hr

5. 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

6. Willing and able to give informed consent

Exclusion Criteria:

1. Systemic diseases that may cause mesangial IgA deposition.

2. Patients who have undergone a kidney transplant.

3. Patients with acute or chronic infectious disease including hepatitis, tuberculosis,
human immunodeficiency virus (HIV), and chronic urinary tract infections.

4. Patients with liver cirrhosis, as assessed by the Investigator.

5. Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly
controlled.

6. Patients with history of unstable angina, class III or IV congestive heart failure,
and/or clinically significant arrhythmia, as judged by the Investigator;

7. Patients with unacceptable blood pressure control defined as a blood pressure
consistently above national guidelines for proteinuric renal disease, as assessed by
the Investigator

8. Patients with diagnosed malignancy within the past 5 years.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary IgA Nephropathy

Intervention(s)

Drug: Nefecon

Drug: Placebo oral capsule

Primary Outcome(s)

Change in Proteinuria, measured as Urine Protein to creatinine ratio (UPCR). [Time Frame: 9 months]

Renal function measured as estimated glomerular filtration rate (eGFR) [Time Frame: Up to 2 years]

Secondary Outcome(s)

Renal function [Time Frame: Up to 2 years]

The incidence of treatment-emergent adverse events. [Time Frame: From enrollment and up to 2 years]

Secondary ID(s)

Nef-301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors