Skip to main content
OpenTrials
Completed

NCT Number: NCT03643965

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Britanico de Buenos Aires, Pedriel 74, Capital Federal, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female or male patients ≥18 years
  • Biopsy-verified IgA nephropathy
  • 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
  • Urine protein creatinine ratio ≥1 g/24hr
  • 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
  • Willing and able to give informed consent

Exclusion criteria

  • Systemic diseases that may cause mesangial IgA deposition.
  • Patients who have undergone a kidney transplant.
  • Patients with acute or chronic infectious disease including hepatitis, tuberculosis, human immunodeficiency virus (HIV), and chronic urinary tract infections.
  • Patients with liver cirrhosis, as assessed by the Investigator.
  • Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled.
  • Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
  • Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator
  • Patients with diagnosed malignancy within the past 5 years.

Treatment and study plan

NEFECON

Drug

Nefecon 16 mg for daily administration by mouth for 9 months.

Other names: Budesonide modified released capsule

Placebo oral capsule

Drug

Placebo capsules for daily administration by mouth for 9 months.

Other names: Placebo

Primary outcomes

  1. Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline

    Time frame: 9 months

    Part A primary endpoint: The ratio of Urine Protein to Creatinine Ratio (UPCR) (based on 24-hour urine collections) at 9 months following the first dose of study drug compared to baseline.

    Ratio being: UPCR at 9 months in g/gram divided with UPCR at Baseline in g/gram

  2. Part B: Time-weighted Average of Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Up to 2 years and 1 month

    Part B Primary endpoint: Time-weighted average of estimated glomerular filtration rate (eGFR) recordings observed at each time point over 2 years. The eGFR (CKD-EPI) at 2 years (which must have been repeated to provide a second value obtained within 14 to 35 days) was the geometric mean of the 2 assessments.

Secondary outcomes

  1. Part A: Ratio of eGFR at 9 Months

    Time frame: 9 months

    Part A: Ratio of eGFR at 9 months compared to baseline calculated using the CKD-EPI formula.

  2. Part A: Ratio of eGFR at 12 Months

    Time frame: 12 months

    Part A: Ratio of eGFR at 12 months compared to baseline calculated using the CKD-EPI formula.

  3. Part A: Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months

    Time frame: 9 months

    Part A: Ratio of urine albumin to creatinine ratio (UACR) at 9 months compared to baseline.

  4. Part B: Time to 30% Reduction in eGFR

    Time frame: Over 2 years

    Part B: Time to 30% reduction from baseline in eGFR (CKD-EPI) confirmed by a second value.

    For clarity: Please note that the number of patients with a 30% reduction is presented with statistical analysis of the time to 30% reduction.

  5. Part B: Time to Receiving Rescue Medication.

    Time frame: Over 2 years

    Part B: Time from the first dose of study drug until receiving rescue medication.

    For clarity: Please note that the number of patients receiving rescue medication is presented with statistical analysis of the time to receiving rescue medication.

  6. Part B: Ratio of UPCR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months

    Time frame: 12, 18 and 24 months

    Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug

  7. Part B: Ratio of UACR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months

    Time frame: 12 to 24 months

    Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug.

  8. Part B: Ratio of eGFR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months

    Time frame: 12 to 24 months

    Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug;

  9. Part B: Proportion of Patients Without Microhematuria

    Time frame: 12 to 24 months

    Part B: Proportion of patients without microhematuria in at least 2 of the following time points: 12, 18, and 24 months following the first dose of study drug

  10. Part B: Short Form 36 (SF-36) Quality of Life Assessment at 9 Months.

    Time frame: 9 months

    Part B: Short Form 36 (SF-36) quality of life assessment at 9 and 24 months.

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used. It consists of eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.

    Higher scores indicate better health. Scores represent the percentage of total possible score achieved.

  11. Part B: Short Form 36 (SF-36) Quality of Life Assessment at 24 Months.

    Time frame: 24 months

    Part B: Short Form 36 (SF-36) quality of life assessment at 9 and 24 months.

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used. It consists of eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.

    Higher scores indicate better health. Scores represent the percentage of total possible score achieved.

Sponsors and collaborators

Lead sponsor

Calliditas Therapeutics AB

Industry

Registry information

Official study 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)

Acronym: Nefigard

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2018
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.