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

ISRCTN70791258.

Study name Treatment with adrenocorticotropic hormone in idiopathic membranous nephropathy
Methods
  • Study design: parallel, open‐label RCT

  • Study duration: 6 July 1999 to 31 January 2005

  • Sample size: target 30

Participants
  • Setting: not reported

  • Country: Sweden

  • Inclusion criteria: males and females, aged 18 to 90 years; membranous nephropathy according to kidney biopsy; proteinuria of the nephrotic range for at least 6 months; treatment with a statin and an ACEi for at least 3 months; urinary albumin excretion > 3000 mg/24 hours; serum albumin concentration < 26 g/L

  • Exclusion criteria: moderate or heavy tubulointerstitial changes in the kidney biopsy; recognisable cause of the nephrotic syndrome; previous immunosuppressive treatment for the membranous nephropathy; allergy to Synacthen Depot; severe psychiatric disease; pregnancy; history of noncompliance

Interventions Group 1
  • Depot preparation of a synthetic fragment of ACTH versus no specific treatment. The dosage scheme of Synacthen Depot given subcutaneously was as follows:

    • Month one: 1.0 mg once/week

    • Month two: 0.75 mg twice/week

    • Months three to six: 1.0 mg twice/week

    • Month seven: 0.75 mg twice/week

    • Month eight: 1.0 mg once/week

    • Month nine: 0.5 mg once/week


Control group
  • Supportive therapy

Outcomes
  • Complete remission, at 9 and 21 months

  • Complete and partial remission at the end of the treatment period (9 months after study start) and at the end of the follow‐up period (21 months after study start)

  • Serum albumin

  • SCr

  • Apolipoprotein A1

  • Apolipoprotein B

  • Lipoprotein(a)

  • Urinary excretion/24 hours of albumin

  • Immunoglobulin G

  • Protein HC

  • GFR

  • Mean arterial pressure

Starting date  
Contact information  
Notes Funding source: Department of Nephrology, University Hospital in Lund (Sweden)
Information from trial registration site only (June 2018), emailed Ann‐lena.berg@njur.lu.se and sponsor kerstin.wihlborg@med.lu.se on 13 Jun 2018