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. 2021 Nov 15;2021(11):CD004293. doi: 10.1002/14651858.CD004293.pub4

ChiCTR‐INR‐17012212.

Study name Use of sirolimus in patients with primary idiopathic membranous nephropathy: a prospective randomised control trial
Methods
  • Study design: RCT

  • Study duration: planned 28 July 2017 to 31 May 2019

  • Sample size: 70 planned

Participants
  • Setting: single centre

  • Country: China

  • Inclusion criteria: 18 to 70 years; diagnosed as primary membranous nephropathy by renal biopsy and exclusion of secondary causes; corticosteroids and immunosuppressive agents not in the recent 3 months; BP < 140/90 mm Hg; proteinuria ≥ 3.5 g/day and eGFR ≥ 45mL/min/1.73 m²; with at least 3‐month treatment of maximum tolerance dosage of ACEi/ARB; SCr ≤ 133 µmol/L; agree to sign informed consent

  • Exclusion criteria: any type of secondary membranous nephropathy by renal biopsy; any other type of kidney disease; uncontrolled infection; Interstitial pneumonia; new onset of cardiovascular disease in recent 3 months; severe liver disease, liver enzyme elevation is not higher than 3 times; uncontrolled severe hypertension; A new or recurring malignancy within 8.5 years; peptic ulcer or active digestive tract bleeding; severe autoimmune disease; pregnancy, lactation or scheduled pregnancy; expected survival was less than December; other clinical studies are currently in progress; do not agree to sign informed consent; the researchers found other conditions unsuitable for the study

Interventions Group 1
  • CSA


Group 2
  • CSA + sirolimus

Outcomes
  • Proteinuria

Starting date 28 July 2017
Contact information Fang Wang, wangfang@bjmu.edu.cn
Notes Sponsor: Huabei Pharmaceutical Company
Status: recruiting (refreshed 1 Aug 2017)