問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberNef-301

2019-03-26 - 2023-02-06

Phase III

Recruiting3

ICD-10N02.8

Recurrent and persistent hematuria with other morphologic changes

ICD-9585

Chronic renal failure

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd)

  • Trial Applicant

    MEDPACE TAIWAN LIMITED

  • Sponsor

    Calliditas Therapeutics AB

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator CHENG-HSU CHEN Division of Nephrology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Junne-Ming Sung Division of Nephrology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Yi wen chiu Division of Nephrology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Immunoglobulin A nephropathy

Objectives

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).

Test Drug

Nefecon™

Active Ingredient

budesonide

Dosage Form

capsule

Dosage

4 mg

Endpoints

Primary Outcome Measures :
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

Renal function measured as estimated glomerular filtration rate (eGFR) [ Time Frame: Up to 2 years ]
Based on eGFR measure compared to baseline calculated using the CKD-EPI formula


Secondary Outcome Measures :
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

Inclution Criteria

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 ≥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
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.

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    450 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB