Skip to main content
. 2020 Mar 12;2020(3):CD003965. doi: 10.1002/14651858.CD003965.pub3

NEFIGARD 2018.

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
  • Nefecon (oral): 16 mg/month (Budosenide modified released capsule) for 9 months


Treatment group 2
  • Placebo capsules (oral): daily administration for 9 months

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