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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04541043
Other study ID # Nef-301 OLE
Secondary ID 2020-003308-14
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 14, 2020
Est. completion date June 30, 2024

Study information

Verified date July 2023
Source Calliditas Therapeutics AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 119
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients that completed study Nef-301 2. 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 3. Willing and able to provide written informed consent. 4. UPCR equal to or more than 0.8 g/gram 5. 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: 1. Systemic diseases that may cause mesangial IgA deposition. 2. Patients who have undergone a kidney transplant; 3. Patients with presence of other glomerulopathies and/or nephrotic syndrome 4. Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections; 5. Patients with liver cirrhosis, as assessed by the Investigator; 6. Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled 7. Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator; 8. Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator. 9. Patients with diagnosed malignancy within the past 5 years.

Study Design


Intervention

Drug:
Nefecon
Nefecon is taken orally as capsules once daily in the morning for 9 months.

Locations

Country Name City State
Sweden Uppsala University Hospital Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Calliditas Therapeutics AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 9 months
Primary 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. 9 months
Secondary The incidence of treatment emergent adverse events Adverse event data collection From enrollment up to 12 months
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