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. 2020 Mar 12;2020(3):CD003965. doi: 10.1002/14651858.CD003965.pub3

NCT03468972.

Trial name or title Effect of immunosuppression in IgA nephropathy
Methods Parallel RCT
Participants
  • Setting: multicentre (19 hospitals)

  • Country: Korea

  • Patients with biopsy‐proven IgAN within 5 years; persistent proteinuria who have preserved eGFR of ≥ 30 mL/min/1.73 m2; proteinuria < 1.0 g/g creatinine; 19 to 75 years, baseline eGFR ≥ 30 mL/min/1.73 m2 assessed by CKD‐EPI equation

  • Number: estimated 87 subjects (a total of 174) would be required for each group

  • Mean age ± SD (years): not yet available

  • Sex (M/F): not yet available

  • Exclusion criteria: nephrotic syndrome, atypical IgAN; crescents ≥ 25%; overt pulmonary tuberculosis; malignancy within 5 years of enrolment; pregnancy or breast feeding; active hepatitis, chronic hepatitis, liver cirrhosis, HIV; kidney transplant; current use of immunosuppressive treatment or prior use of immunosuppressive drugs within 1 year of enrolment; uncontrolled hypertension (> 160/100 mmHg); aged < 19 years; secondary IgAN such as lupus nephritis, chronic liver disease, or HSP; involvement of other clinical trials within 3 months of enrolment

Interventions Treatment group 1
  • Corticosteroid


Treatment group 2
  • Supportive care: including the use of RAS blockers, BP control with a target of < 130/80 mmHg, and protein restriction diet

Outcomes
  • Development of a ≥ 30% decline in eGFR

  • Onset of ESKD

  • Changes in urinary protein excretion and haematuria

Starting date Estimated March 2019
Contact information Seung Hyeok Han
82‐2‐2228‐1984
hansh@yuks.ac
Notes Estimated study completion date: May 2023
No study results available