A study to assess if two different doses of Nefecon taken as a capsule are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease
- Conditions
- MedDRA version: 15.0Level: LLTClassification code 10037034Term: Proteinuria presentSystem Organ Class: 10038359 - Renal and urinary disordersPrimary IgA nephropathy at risk of developing end stage renal diseaseTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-001923-11-IT
- Lead Sponsor
- CROWN OY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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)
4.eGFR =50 mL/min per 1.73 m2 using CKD-EPI formula
5.Willing to change antihypertensive medication regimen if applicable
6.Willing and able to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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.Patients previously treated with immunosuppressive or systemic corticosteroids for the treatment of IgA nephropathy
11.Patients unable to take oral medication or intolerant to budesonide or other corticosteroid preparations
12.Patients with known allergy or intolerance to ACEI, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the trial is to evaluate efficacy and safety of two different doses of Nefecon in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin 2 receptor blocker (ARB).;Secondary Objective: To investigate whether patients on Nefecon achieve a larger mean reduction in urine protein creatinine ratio (UPCR) compared to patients on placebo at 9 months compared to baseline UPCR values;Primary end point(s): To investigate whether patients on Nefecon achieve a larger mean reduction in urine protein creatinine ratio (UPCR) compared to patients on placebo during a 9 months trial;Timepoint(s) of evaluation of this end point: Nine months of treatment
- Secondary Outcome Measures
Name Time Method