A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease
- Conditions
- Berger's diseaseIgA Nephropathy10029149
- Registration Number
- NL-OMON39659
- Lead Sponsor
- Pharmalink AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Screening Inclusion Criteria: ;1. Female or male patients >=18 years;2. Biopsy-verified IgA nephropathy;3. Urine protein creatinine ratio >=0.5 g/g (56.5 mg/mmol) OR urine protein >=0.75 g/24 h;4. Estimated GFR (using the CKD-EPI formula) OR measured GFR >=50 mL/min per 1.73 m2 OR >=45 mL/min per 1.73 m2 for patients on a maximum recommended or maximum tolerated dose of an ACEI and/or ARB;5. Willing to change antihypertensive medication regimen if applicable;6. Willing and able to give informed consent;Randomisation Inclusion Criteria:;1. Completion of the Run-in Phase;2. Urine protein creatinine ratio >=0.5 g/g (56.5 mg/mmol) OR urine protein >=0.75 g/24 h;3. Estimated GFR (using CKD-EPI formula) OR measured GFR >=45 mL/min per 1.73 m2
Screening 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;5. Consumption of an investigational drug within 30 days prior to enrolment;6. Hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the Investigator;7. Morbid obesity defined as a body mass index (BMI) >45 kg/m2;8. 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.;9. 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;10. For the treatment of IgA nephropathy, patients treated within the last 24 months with either immunosuppressive agents or systemic corticosteroid drugs ;11. Patients unable to take oral medication or intolerant to budesonide or other corticosteroid preparations;12. Patients with known allergy or intolerance to ACEI and ARB or to any component of the trial drug formulation;13. Patients with acute or chronic infectious disease incl. hepatitis, HIV positive patients and patients with chronic urinary tract infections;14. Severe liver disease according to the discretion of the Investigator;15. Patients with Type 1 or 2 diabetes;16. Patients with uncontrolled cardiovascular disease as judged by the Investigator;17. Patients with current malignancy or history of malignancy during the last three years;18. History or presence of psychological or psychiatric illness (including steroid induced psychosis) which may interfere with the patient*s ability to adhere to the protocol;19. Patients with untreated osteoporosis;20. Patients with glaucoma or cataract;21. Alcohol or drug abuse (present);22. Patients unwilling to meet the requirements of the protocol;23. Other medical or social reasons for exclusion at the discretion of the Investigator;24. Life expectancy < 1 year;25. For women only; pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential);Randomisation Exclusion Criteria:;1. Unacceptable blood pressure defined as a systolic value >160 mm Hg or diastolic >100 mm Hg;2. eGFR (CKD-EPI method of estimation) loss >30% over the entire duration of the Run-in Phase ;3. Consumption of an investigational drug after screening;4. Medical or social reasons for exclusion at the discretion of the Investigator;5. For women only; pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential) ;6. For men only; unwilling to use adequate contraception during the treatment and follow-up phase of the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Endpoint(s)<br /><br>The primary endpoint is the mean reduction in UPCR at 9 months compared to<br /><br>baseline UPCR values. The mean reduction will be measured as ratio of UPCR at 9<br /><br>months compared to baseline.</p><br>
- Secondary Outcome Measures
Name Time Method