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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
Date last updated
18/07/2023

Titles & IDs
Public title
Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
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)
Secondary ID [1] 0 0
Nef-301
Universal Trial Number (UTN)
Trial acronym
Nefigard
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary IgA Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Proteinuria, measured as Urine Protein to creatinine ratio (UPCR).
Timepoint [1] 0 0
9 months
Primary outcome [2] 0 0
Renal function measured as estimated glomerular filtration rate (eGFR)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [1] 0 0
The incidence of treatment-emergent adverse events.
Timepoint [1] 0 0
From enrollment and up to 2 years
Secondary outcome [2] 0 0
Renal function
Timepoint [2] 0 0
Up to 2 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/07/2023
Sample size
Target
Accrual to date
Final
365
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Royal Adelaide Hospital, Port Rd. - Adelaide
Recruitment hospital [3] 0 0
Box Hill Hospital, Dept of Renal Medicine, Arnold Str 5 - Box Hill
Recruitment hospital [4] 0 0
Austin Health, Dept of Nephrology, 145 Studley Rd. - Heidelberg
Recruitment hospital [5] 0 0
Melbourne Health, Royal Melbourne Hospital, Dept of Nephrology,Grattan Str. - Parkville
Recruitment hospital [6] 0 0
Prince of Wales Hospital, Nephrology Dept, Parkes 3 West - Randwick
Recruitment hospital [7] 0 0
Western Health, Western Hospital-Sunshine Hospital, 176 Furlong Rd, Level 3, WHCRE Building - St Albans
Recruitment hospital [8] 0 0
Westmead Hospital, Dept of Renal Medicine, Hawkesbury Rd. - Westmead
Recruitment hospital [9] 0 0
Metro South Hospital and Health Service via Princess Alexandra Hospital, Dept of Nephrology, 199 Ipswich Rd. - Woolloongabba
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
2031 - Randwick
Recruitment postcode(s) [7] 0 0
3021 - St Albans
Recruitment postcode(s) [8] 0 0
2145 - Westmead
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Calliditas Therapeutics AB
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT03643965
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.
Public notes

Contacts
Principal investigator
Name 0 0
Krassimir Mitchev, MD
Address 0 0
Calliditas AB
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03643965