A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.
- Conditions
- Primary IgA nephropathy patients at risk of developing end stage renal diseaseMedDRA version: 20.0Level: LLTClassification code 10069341Term: Berger's diseaseSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2017-004902-16-ES
- Lead Sponsor
- Calliditas Therapeutics AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 450
Patients must meet all of the following inclusion criteria at screening to be eligible for admission into the study:
1. Female or male patients 18 years of age;
2. Diagnosed IgAN with biopsy verification within the past 5 years;
3. On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or MTD according to the 2012 KDIGO guidelines for the 3 months prior to screening. In this instance, a stable dose is defined as doses within 25% of the dose at screening. Patients that are on a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) that is below the maximum allowed dose or MTD according to the 2012 KDIGO guidelines will be permitted into the study if an attempt to reach the maximum allowed dose or MTD was previously performed; and
4. Willing and able to provide written informed consent at screening.
In addition, patients must meet the following inclusion criteria before randomization into the study:
5. Proteinuria based on 2 consecutive measurements (based on 24-hour urine sampling) after informed consent, separated by at least 2 weeks and calculated by the central laboratory. Both samples must show either of the following:
- Proteinuria ?1 g per day, or
- UPCR ?0.8 g/gram; and
6. eGFR ?45 mL/min per 1.73 m2 and 90 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, confirmed by the central laboratory.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 410
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
Patients who meet any of the following exclusion criteria at screening will not be eligible for admission into the study:
1. Systemic diseases that may cause mesangial IgA deposition including, but not limited to, Henoch Schönlein purpura, systemic lupus erythematosus, dermatitis herpetiformis, and ankylosing spondylitis;
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 (defined as hemoglobin A1c [HbA1c] 8% [64 mmol/mol]);
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; patients with 140 mmHg systolic blood pressure or 90 mmHg diastolic blood pressure are not eligible;
8. Patients with diagnosed malignancy within the past 5 years, except for treated basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, colon polyps, or cervical carcinoma in situ;
9. Patients with known osteoporosis in medium- or high-risk category according to the 2010 American College of Rheumatology recommendations;
10. Patients with known glaucoma, known cataract(s), and/or history of cataract surgery, unless the surgery was performed on both eyes;
11. Gastrointestinal disorders (eg, peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea) that may interfere with the effects of the study drug;
12. Patients with hypersensitivity to budesonide or any component of the study drug formulation;
13. Patients with previous severe adverse reactions to steroids, at the discretion of the Investigator, including psychotic symptoms;
14. Patients who have been treated with immunosuppressive medications, other than GCSs, within the past 2 years. See Appendix F for more information on immunosuppressive medications;
15. Patients who have been treated with any systemic GCSs within the past 3 months;
16. Patients who have been treated with any systemic GCSs within the past 2 years except for a maximum of 3 periods of 2 weeks with the equivalent of 0.5 mg/kg prednisolone or less, for non-IgAN indications;
17. Patients taking potent inhibitors of cytochrome P450 (CYP) 3A4;
18. Current or prior (within the past 2 years) alcohol or drug abuse;
19. Intake of an investigational drug within 30 days and at least 5 half-lives;
20. Patients unwilling or unable to meet the requirements of the protocol;
21. Other medical or social reasons for exclusion at the discretion of the Investigator;
22. Life expectancy 5 years;
23. Females who are pregnant, breastfeeding, or unwilling to use highly-effective contraception during the Treatment Period and the 3-month Follow-up Period in Part A of the study (contraception only required for women of childbearing potential [WOCBP]);
- Highly-effective methods of contraception are defined as those that achieve a low failure rate (1% per year) when used consistently and correctly. Such methods include the use of combined (estrogen and progesterone) hormonal contraceptives (oral, intravaginal, or
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method