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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
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
Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline
Timepoint [1] 0 0
9 months
Primary outcome [2] 0 0
Part B: Time-weighted Average of Estimated Glomerular Filtration Rate (eGFR)
Timepoint [2] 0 0
Up to 2 years and 1 month
Secondary outcome [1] 0 0
Part A: Ratio of eGFR at 9 Months
Timepoint [1] 0 0
9 months
Secondary outcome [2] 0 0
Part A: Ratio of eGFR at 12 Months
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Part A: Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months
Timepoint [3] 0 0
9 months
Secondary outcome [4] 0 0
Part B: Time to 30% Reduction in eGFR
Timepoint [4] 0 0
Over 2 years
Secondary outcome [5] 0 0
Part B: Time to Receiving Rescue Medication.
Timepoint [5] 0 0
Over 2 years
Secondary outcome [6] 0 0
Part B: Ratio of UPCR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months
Timepoint [6] 0 0
12, 18 and 24 months
Secondary outcome [7] 0 0
Part B: Ratio of UACR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months
Timepoint [7] 0 0
12 to 24 months
Secondary outcome [8] 0 0
Part B: Ratio of eGFR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months
Timepoint [8] 0 0
12 to 24 months
Secondary outcome [9] 0 0
Part B: Proportion of Patients Without Microhematuria
Timepoint [9] 0 0
12 to 24 months
Secondary outcome [10] 0 0
Part B: Short Form 36 (SF-36) Quality of Life Assessment at 9 Months.
Timepoint [10] 0 0
9 months
Secondary outcome [11] 0 0
Part B: Short Form 36 (SF-36) Quality of Life Assessment at 24 Months.
Timepoint [11] 0 0
24 months

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Results publications and other study-related documents

No documents have been uploaded by study researchers.