Purpose

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Female or male patients ≥18 years 2. Biopsy-verified IgA nephropathy 3. Stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or Maximum Tolerated Dose (MTD) according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guidelines 4. Urine protein creatinine ratio ≥1 g/24hr 5. eGFR ≥45 mL/min per 1.73 m2 and ≤90 mL/min per 1.73 m2 using the Chronic Kidney Diseae Epidemiology Collaboration (CKD-EPI) formula 6. Willing and able to give informed consent

Exclusion Criteria

  1. Systemic diseases that may cause mesangial IgA deposition. 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. 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 8. Patients with diagnosed malignancy within the past 5 years.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nefecon
Nefecon 16 mg once daily by mouth for 9 months.
  • Drug: Nefecon
    Nefecon 16 mg for daily administration by mouth for 9 months.
    Other names:
    • Budesonide modified released capsule
Placebo Comparator
Placebo oral capsule
Placebo oral capsule once daily by mouth for 9 months.
  • Drug: Placebo oral capsule
    Placebo capsules for daily administration by mouth for 9 months.
    Other names:
    • Placebo

Recruiting Locations

University of Alabama at Birmingham, 1720 2nd Ave South
Birmingham, Alabama 35294-3412

More Details

Status
Recruiting
Sponsor
Calliditas Therapeutics AB

Study Contact

Medpace Research, Inc
+1.800.730.5779
info@medpace.com

Detailed Description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of oral Nefecon compared to matching placebo in patients with primary IgAN on a background of optimized RAS inhibitor therapy. The study will consist of 2 parts, Part A and Part B. Part A will include a 9 month blinded Treatment Period, and a 3-month Follow up Period. Part B of the study will consist of a 12-month observational Follow up Period; no study drug will be administered during Part B. Part A and B will be blinded. Safety will be monitored by an independent Data Safety Monitoring Board.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.