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

TOPplus‐IgAN 2013.

Trial name or title Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced‐stage IgA Nephropathy (TOPplus‐IgAN)
Methods Parallel RCT
Participants
  • Setting: single centre

  • Country: China

  • Biopsy‐proven primary IgAN; aged 18 to 70 years; elevated SCr and < 3.0 mg/dL

  • Number: 122 participants planned

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

  • Sex (M/F): not yet available

  • Exclusion criteria: DM; contraindications for the treatment of prednisone and/or CPA, any treatment with steroids or immunosuppressive drugs prior to this study, acute deterioration of renal function(including those of glomerular origin)

Interventions Treatment group 1
  • Prednisone: 0.5 mg/kg/day for 6 months

  • CPA (IV): 1 g/ month for 6 months


Treatment group 2
  • Prednisone: 0.5 mg/kg/day for 6 months


Co‐interventions
  • Supportive care, including ACEi or ARB and BP control

Outcomes
  • Changes of kidney function or death

  • Changes of proteinuria

Starting date December 2012
Contact information Principal Investigator: Wei Shi. Guangdong General Hospital
Notes Study completion: December 2019
No study results available