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Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy (Nefigard)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03643965
Recruitment Status : Active, not recruiting
First Posted : August 23, 2018
Last Update Posted : December 13, 2021
Sponsor:
Information provided by (Responsible Party):
Calliditas Therapeutics AB

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Primary IgA Nephropathy Drug: Nefecon Drug: Placebo oral capsule Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in Proteinuria, measured as Urine Protein to creatinine ratio (UPCR). [ Time Frame: 9 months ]
    The primary outcome measure is UPCR (based on 24-hour urine collections) at 9 months following the first dose of study drug compared to baseline

  2. Renal function measured as estimated glomerular filtration rate (eGFR) [ Time Frame: Up to 2 years ]
    Based on eGFR measure compared to baseline calculated using the CKD-EPI formula


Secondary Outcome Measures :
  1. The incidence of treatment-emergent adverse events. [ Time Frame: From enrollment and up to 2 years ]
    Adverse event data collection

  2. Renal function [ Time Frame: Up to 2 years ]
    Renal function measured as eGFR using the CKD-EPI formula


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥35 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643965


Locations
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Sponsors and Collaborators
Calliditas Therapeutics AB
Investigators
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Study Director: Krassimir Mitchev, MD Calliditas AB
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Calliditas Therapeutics AB
ClinicalTrials.gov Identifier: NCT03643965    
Other Study ID Numbers: Nef-301
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: December 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Calliditas Therapeutics AB:
IgA Nephropathy
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists