EUCTR2017-004902-16-PLActive, not recruitingPhase 1
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). - NefIgArd
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Calliditas Therapeutics AB
- Enrollment
- 360
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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 10 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 randomization (see Appendix D). In this instance, a stable dose is defined as doses within 25% of the dose at randomization. Patients on a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) 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 has been performed or if such attempt is deemed unsafe for the patient by the Investigator; and Note: It is recommended that patients achieve a target systolic blood pressure <125 mmHg and target diastolic blood pressure <75 mmHg according to the 2012 KDIGO guidelines.
- •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 of the same parameter must show either of the following:
- •- Proteinuria = 1 g per day (=1000 mg per day) in 2 consecutive measurements, or
- •- UPCR = 0.8 g/gram (=90 mg/mmol) in 2 consecutive measurements; and
- •6. eGFR = 35 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 at Study Visit 1 or Study Visit 3.
- •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 328
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
Exclusion Criteria
- •Systemic diseases that may cause mesangial IgA deposition including, but not limited to, Henoch Schönlein purpura, systemic lupus
- •erythematosus, dermatitis herpetiformis, and ankylosing spondylitis; Patients who have undergone a kidney transplant;Patients with presence of other glomerulopathies (e.g.C3 glomerulopathy and/or diabetes nephropathy) and with nephrotic syndrome (i.e.proteinuria >3.5 g per day and with serum albumin <3.0 g/dL, with or without edema); Patients with acute, chronic or latent infectious disease including
- •hepatitis, tuberculosis, human immunodeficiency virus , and chronic urinary tract infections; Patients with liver cirrhosis, as assessed by the
- •Investigator; 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]); Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator; 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. At least one blood pressure measurement at either Study Visit 1 or Study Visit 3 should be within
- •these limits (based on up to 3 measurements, measured 1 minute apart, after resting in the supine position for at least 5 minutes); 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; Patients with known osteoporosis in medium- or high-risk category according to the 2010 American College of Rheumatology recommendations. For patients in China, the medium- or high-risk category is defined according to the Osteoporosis Self Assessment Tool for Asians (OSTA) index; Patients with known glaucoma, known cataract(s), and/or history of cataract surgery, unless the surgery was performed on both eyes; Gastrointestinal disorders (e.g., peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea) that may interfere with the effects or release of the study drug; Patients with hypersensitivity to budesonide or any component of the study drug formulation; Patients with previous severe adverse reactions to steroids, at the discretion of the Investigator, including psychotic symptoms; Patients who have been treated with systemic immunosuppressive medications, other than GCSs, within the 12 months before randomization; Patients who have been
- •treated with any systemic GCSs within the 3 months before randomization; Patients who have been treated with any systemic GCSs within the 12 months before randomization except for a maximum of 3 periods of 2 weeks with the equivalent of 0.5 mg/kg/day prednisolone
- •or less for non-IgAN indications; Patients taking potent inhibitors of cytochrome P450 3A4 (CYP3A4);Current or prior (within the past 2
- •years) alcohol or drug abuse; Intake of an investigational drug within 30 days and at least 5 half-lives before randomization; Patients unwilling or unable to meet the requirements of the protocol; Other medical or social reasons for exclusion at the discretion of the Investigator; Life expectancy <5 years; Females who are pregnant, breastfeeding, or unwilling to use highly-effective contracepti
Investigators
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