Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE) (Nefigard-OLE)
Primary Purpose
Primary IgA Nephropathy
Status
Active
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Nefecon
Sponsored by
About this trial
This is an interventional treatment trial for Primary IgA Nephropathy
Eligibility Criteria
Inclusion Criteria:
- Patients that completed study Nef-301
- 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 guidelines
- Willing and able to provide written informed consent.
- UPCR equal to or more than 0.8 g/gram
- eGFR equal to or more than 30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Exclusion Criteria:
- Systemic diseases that may cause mesangial IgA deposition.
- Patients who have undergone a kidney transplant;
- Patients with presence of other glomerulopathies and/or nephrotic syndrome
- Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), 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
- 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 diagnosed malignancy within the past 5 years.
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
active treatment
Arm Description
Nefecon 16 mg once daily by mouth for 9 months
Outcomes
Primary Outcome Measures
Change in urine protein to creatinine ratio (UPCR) after 9 months
The outcome is measured as UPCR based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline.
Change in estimated glomerular filtration rate (eGFR) at 9 months
The outcome is measured as change in eGFR (calculated using the CKD-EPI formula) at 9 months following the first dose of Nefecon compared to baseline.
Secondary Outcome Measures
The incidence of treatment emergent adverse events
Adverse event data collection
Full Information
NCT ID
NCT04541043
First Posted
September 1, 2020
Last Updated
July 17, 2023
Sponsor
Calliditas Therapeutics AB
1. Study Identification
Unique Protocol Identification Number
NCT04541043
Brief Title
Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)
Acronym
Nefigard-OLE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 14, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calliditas Therapeutics AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef-301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon.
Detailed Description
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef 301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon. During Study Nef-301 OLE, the patients and Investigators will remain blinded to treatment given in Study Nef-301.
During Study Nef-301 OLE, patients will receive Nefecon for a 9-month period. The dose may be reduced if clinically relevant adverse events (AEs) develop during the 9-month Treatment Period that the Investigator considers related to the study drug and that mandate dose reduction.
Patients will remain on a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) throughout the study. The patient will come for a follow-up visit at 12 months after first dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary IgA Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
This is an open label, single-arm study with active treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active treatment
Arm Type
Experimental
Arm Description
Nefecon 16 mg once daily by mouth for 9 months
Intervention Type
Drug
Intervention Name(s)
Nefecon
Intervention Description
Nefecon is taken orally as capsules once daily in the morning for 9 months.
Primary Outcome Measure Information:
Title
Change in urine protein to creatinine ratio (UPCR) after 9 months
Description
The outcome is measured as UPCR based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline.
Time Frame
9 months
Title
Change in estimated glomerular filtration rate (eGFR) at 9 months
Description
The outcome is measured as change in eGFR (calculated using the CKD-EPI formula) at 9 months following the first dose of Nefecon compared to baseline.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
The incidence of treatment emergent adverse events
Description
Adverse event data collection
Time Frame
From enrollment up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients that completed study Nef-301
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 guidelines
Willing and able to provide written informed consent.
UPCR equal to or more than 0.8 g/gram
eGFR equal to or more than 30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Exclusion Criteria:
Systemic diseases that may cause mesangial IgA deposition.
Patients who have undergone a kidney transplant;
Patients with presence of other glomerulopathies and/or nephrotic syndrome
Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), 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
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 diagnosed malignancy within the past 5 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Philipson, MD
Organizational Affiliation
Calliditas Therapeutics AB
Official's Role
Study Director
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)
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