Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03643965
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Calliditas Therapeutics AB

Tracking Information
First Submitted Date  ICMJE August 8, 2018
First Posted Date  ICMJE August 23, 2018
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE September 5, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • 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
  • Events based on renal function measured as estimated glomerular filtration rate (eGFR) [ Time Frame: Up to 2 years ]
    Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • 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
  • Events based on renal function measured as estimated glomerular filtration rate (eGFR) [ Time Frame: Up to 6 years ]
    Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • The incidence of treatment-emergent adverse events. [ Time Frame: From enrollment and up to 2 years ]
    Adverse event data collection
  • Renal function [ Time Frame: Up to 2 years ]
    Renal function measured as eGFR using the CKD-EPI formula
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • The incidence of treatment-emergent adverse events. [ Time Frame: From enrollment and up to 6 years ]
  • Renal function [ Time Frame: Up to 6 years ]
    Renal function measured as eGFR using the CKD-EPI formula
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
Official Title  ICMJE 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)
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary IgA Nephropathy
Intervention  ICMJE
  • Drug: Nefecon
    Nefecon 16 mg for daily administration by mouth for 9 months.
    Other Name: Budesonide modified released capsule
  • Drug: Placebo oral capsule
    Placebo capsules for daily administration by mouth for 9 months.
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Nefecon
    Nefecon 16 mg once daily by mouth for 9 months.
    Intervention: Drug: Nefecon
  • Placebo Comparator: Placebo oral capsule
    Placebo oral capsule once daily by mouth for 9 months.
    Intervention: Drug: Placebo oral capsule
Publications * Fellström BC, Barratt J, Cook H, Coppo R, Feehally J, de Fijter JW, Floege J, Hetzel G, Jardine AG, Locatelli F, Maes BD, Mercer A, Ortiz F, Praga M, Sørensen SS, Tesar V, Del Vecchio L; NEFIGAN Trial Investigators. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet. 2017 May 27;389(10084):2117-2127. doi: 10.1016/S0140-6736(17)30550-0. Epub 2017 Mar 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 19, 2020)
360
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2018)
450
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medpace Research, Inc +1.800.730.5779 info@medpace.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belarus,   Belgium,   Canada,   Czechia,   Finland,   France,   Germany,   Greece,   Italy,   Korea, Republic of,   Poland,   Spain,   Sweden,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03643965
Other Study ID Numbers  ICMJE Nef-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Calliditas Therapeutics AB
Study Sponsor  ICMJE Calliditas Therapeutics AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Krassimir Mitchev, MD Calliditas AB
PRS Account Calliditas Therapeutics AB
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP