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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03643965
Registration number
NCT03643965
Ethics application status
Date submitted
8/08/2018
Date registered
23/08/2018
Titles & IDs
Public title
Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
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Scientific 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)
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Secondary ID [1]
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Nef-301
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Universal Trial Number (UTN)
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Trial acronym
Nefigard
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Primary IgA Nephropathy
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0
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Condition category
Condition code
Renal and Urogenital
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0
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Kidney disease
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Inflammatory and Immune System
0
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nefecon
Treatment: Drugs - Placebo oral capsule
Experimental: Nefecon - Nefecon 16 mg once daily by mouth for 9 months.
Placebo comparator: Placebo oral capsule - Placebo oral capsule once daily by mouth for 9 months.
Treatment: Drugs: Nefecon
Nefecon 16 mg for daily administration by mouth for 9 months.
Treatment: Drugs: Placebo oral capsule
Placebo capsules for daily administration by mouth for 9 months.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Proteinuria, measured as Urine Protein to creatinine ratio (UPCR).
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Assessment method [1]
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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
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Timepoint [1]
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9 months
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Primary outcome [2]
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Renal function measured as estimated glomerular filtration rate (eGFR)
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Assessment method [2]
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Based on eGFR measure compared to baseline calculated using the CKD-EPI formula
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Timepoint [2]
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Up to 2 years
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Secondary outcome [1]
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The incidence of treatment-emergent adverse events.
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Assessment method [1]
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Adverse event data collection
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Timepoint [1]
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From enrollment and up to 2 years
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Secondary outcome [2]
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Renal function
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Assessment method [2]
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Renal function measured as eGFR using the CKD-EPI formula
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Timepoint [2]
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Up to 2 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/09/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/07/2023
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Sample size
Target
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Accrual to date
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Final
365
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre - Clayton
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Royal Adelaide Hospital, Port Rd. - Adelaide
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Box Hill Hospital, Dept of Renal Medicine, Arnold Str 5 - Box Hill
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Austin Health, Dept of Nephrology, 145 Studley Rd. - Heidelberg
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Melbourne Health, Royal Melbourne Hospital, Dept of Nephrology,Grattan Str. - Parkville
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Prince of Wales Hospital, Nephrology Dept, Parkes 3 West - Randwick
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Western Health, Western Hospital-Sunshine Hospital, 176 Furlong Rd, Level 3, WHCRE Building - St Albans
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Westmead Hospital, Dept of Renal Medicine, Hawkesbury Rd. - Westmead
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Metro South Hospital and Health Service via Princess Alexandra Hospital, Dept of Nephrology, 199 Ipswich Rd. - Woolloongabba
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Recruitment postcode(s) [1]
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3168 - Clayton
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5000 - Adelaide
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3128 - Box Hill
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3084 - Heidelberg
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3052 - Parkville
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2031 - Randwick
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3021 - St Albans
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2145 - Westmead
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4102 - Woolloongabba
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Funding & Sponsors
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Name
Calliditas Therapeutics AB
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Ethics approval
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03643965
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Trial related presentations / publications
Fellstrom 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, Sorensen 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. Barratt J, Lafayette R, Kristensen J, Stone A, Cattran D, Floege J, Tesar V, Trimarchi H, Zhang H, Eren N, Paliege A, Rovin BH; NefIgArd Trial Investigators. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy. Kidney Int. 2023 Feb;103(2):391-402. doi: 10.1016/j.kint.2022.09.017. Epub 2022 Oct 19.
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Public notes
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Contacts
Principal investigator
Name
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Krassimir Mitchev, MD
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Address
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Calliditas AB
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03643965