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

NCT02160132.

Methods Parallel RCT
Participants
  • Setting: multicentre

  • Country: China

  • Patients with age 14 to 65 years, regardless of gender; clinical evaluation and renal biopsy diagnostic for IgAN, presenting with active pathological changes,including cellular crescents,necrosis and microthrombus; average urinary protein excretion of 0.5 to 3.5 g/24 hours on two successive examinations; eGFR ≥ 50 mL/min/1.73 m2

  • Number: 180 participants planned

  • Mean age ± SD (years): not available

  • Sex (M/F): not available

  • Exclusion criteria: Secondary IgAN such as SLE, HSP; nephritis and hepatitis B ‐associated nephritis; rapidly progressive nephritic syndrome (crescent formation ≥ 50%); AKI, including rapidly progressive IgAN; current or recent (within 30 days) exposure to high‐dose of steroids or immunosuppressive therapy (CPA, MMF, CSA, FK506); date of renal biopsy exceeds more than 30 days; cirrhosis, chronic active liver disease; history of significant gastrointestinal disorders (e.g. severe chronic diarrhoea or active peptic ulcer disease); any active systemic infection or history of serious infection within one month; other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure, chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases); active tuberculosis; malignant hypertension that is difficult to be controlled by oral drugs; known allergy, contraindication or intolerance to the steroids; pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception; malignant tumours; excessive drinking or drug abuse; mental aberrations; current or recent (within 30 days) exposure to any other investigational drugs

Interventions Treatment group 1
  • IV methylprednisolone 0.5 g/day for 3 consecutive days in the 1st, 2nd and 3rd month, and then oral methylprednisolone 0.4 mg/kg/day on consecutive days for 6 months


Treatment group 2
  • IV Methylprednisolone 0.5 g/day for 3 consecutive days in the 1st, 3rd and 5th month, and then oral methylprednisolone 0.4 mg/kg/day on consecutive days for 6 months

Outcomes
  • Remission of proteinuria (complete or partial)

  • Deterioration of kidney function

  • Longitudinal decline of kidney function (eGFR)

Notes Study completed on December 2016
Emailed investigators on 21.5.2018 to request update on trial status, but not answer was provided
Clinicaltrials.gov identifier: NCT02160132
No study results available