The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease

Exclusion Criteria

• •1. Secondary forms of IgA nephropathy as defined by the treating physician (for example, Henoch-Schönlein purpura patients and those with associated alcoholic cirrhosis)
• •2. Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy
• •3. Kidney transplanted patients 4. Severe gastrointestinal disorders (including peptic ulcer disease and inflammatory bowel disease) which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the Investigator
• •4. Patients currently treated with systemic immunosuppressive or systemic corticosteroid drugs (excluding topical or nasal steroids) or have been previously treated for more than one week within the last 24 months.
• •5. Patients currently treated chronically (daily dosing) with inhaled corticosteroid drugs or have previously been treated chronically for more than one month within the last 12 months
• •6. Patients previously treated with immunosuppressive or systemic corticosteroids for the treatment of IgA nephropathy
• •7. Patients unable to take oral medication or intolerant to budesonide or other corticosteroid preparations
• •8. Patients with known allergy or intolerance to ACEI, ARB or to any component of the trial drug formulation
• •9. Patients with acute or chronic infectious disease incl. hepatitis, HIV positive patients and patients with chronic urinary tract infections
• •10. Severe liver disease according to the discretion of the Investigator
• •11. Patients with Type 1 or 2 diabetes
• •12. Patients with uncontrolled cardiovascular disease as judged by the Investigator
• •13. Patients with current malignancy or history of malignancy during the last three years
• •14. For women only; pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential)
• •1. Unacceptable blood pressure defined as a systolic value \>160 mm Hg or diastolic \>100 mm Hg
• •2. eGFR (CKD-EPI) loss \>30% over the entire duration of the Run-in Phase
• •3. For women only; pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential)