An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 -

CALLIDITAS THERAPEUTICS AB0 个研究点目标入组 250 人开始时间: 2021年5月24日最近更新: 2021年8月30日

研究概览

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•-Completed Study Nef-301, defined as Part A (9-month study drug treatment [Nefecon 16 mg/day or placebo] and 3-month follow-up) and Part B (12-month follow-up);
•-Completed Visit 17b in Study Nef-301 within 3 months before Study Visit 3;
•-On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or maximum tolerated dose according to the 2012 KDIGO guidelines21 (see Appendix C). A stable dose is defined as a dose within 25% of the dose at Visit 17a or 17b in Study Nef 301; and
•-Proteinuria based on 2 consecutive measurements (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: oProteinuria >/=1 g/day (>/=1000 mg/day) in 2 consecutive measurements; or oUPCR >/=0.8 g/gram (>/=90 mg/mmol) in 2 consecutive measurements; and
•-eGFR >/=30 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 227
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 23

•-Had a dose reduction to Nefecon 8 mg/day in Study Nef-301;
•-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 with nephrotic syndrome (i.e., proteinuria >3.5 g/day and with serum albumin <3.0 g/dL, with or without edema);
•-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 1 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 who have received rescue therapy with systemic immunosuppressants, including GCSs, during Study Nef-301;
•-Patients who have been treated with any systemic GCSs within the 3 months before screening;
•-Patients who have been treated with any systemic GCSs within the 12 months before screening 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;

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