Trial name or title |
Efficacy and safety of nefecon in patients with primary IgA (immunoglobulin A) nephropathy (NEFIGARD) |
Methods |
Parallel RCT |
Participants |
Setting: multicentre
Country: multinational
Adult patients with primary biopsy‐proven IgAN at risk of progressing to ESKD; stable dose of RAS inhibitor therapy (ACEi and/or ARB) at the maximum allowed dose or maximum tolerated dose according to the 2012 KDIGO guidelines; UPCR ≥ 1 g/24 hours; eGFR ≥ 45 mL/min/1.73 m2 and ≤ 90 mL/min/1.73 m2 using CKD‐EPI formula; willing and able to give informed consent
Number: estimated 450 participants
Mean age ± SD (years): not yet available
Sex (M/F): not yet available
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, TB, 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 DM 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 BP control defined as a BP consistently above national guidelines for proteinurics renal disease, as assessed by the Investigator; patients with diagnosed malignancy within the past 5 years
|
Interventions |
Treatment group 1
Treatment group 2
|
Outcomes |
Change in proteinuria, measured as UPCR
Events based on renal function measured as eGFR, calculated using the CKD‐EPI formula
The incidence of treatment‐emergent adverse events
Renal function measured as eGFR using the CKD‐EPI formula
|
Starting date |
August 2018 |
Contact information |
Medpace Research, Inc +1 800 730 5779 info@medpace.com |
Notes |
Estimated study completion date: December 2024 No study results available |