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

NCT01386554.

Methods
  • Study design: parallel RCT

  • Study duration: August 2011 to May 2017

  • Duration of follow‐up: 24 weeks

Participants
  • Setting: multicentre

  • Country: USA

  • Inclusion criteria: history of nephrotic syndrome due to PMN as confirmed by documented results from a kidney biopsy performed within 4 years prior to screening

  • Number: 60

  • Age: > 18 years

  • Sex (M/F): both

  • Exclusion criteria: history of previous use of Acthar for treatment of nephrotic syndrome; prior sensitivity to Acthar or other porcine protein products or planned treatment with live or live attenuated vaccines once enrolled in the study; contraindication to Acthar per prescribing Information (scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenocortical hyperfunction; known diabetic nephropathy or nephrotic syndrome due to a disease or process other than idiopathic membranous nephropathy; requiring diagnostic or interventional procedure requiring a contrast agent must delay screening/randomisation for at least 7 days; history of SLE; type 1 or Type 2 DM; history of deep vein thrombosis ≤ 6 months prior to screening visit; history of or active congestive heart failure (NYHA Class II to IV); history of known dilated cardiomyopathy with left ventricular ejection fraction ≤ 40%; occurrence of unstable angina, MI or coronary artery bypass graft or percutaneous transluminal coronary angioplasty; Transient ischaemic attack or cerebrovascular disease or unstable arrhythmia in last 3 months

Interventions Group 1
  • Acthar (Repository Corticotropin injection): 80 U (1.0 mL) twice/week


Group 2
  • Acthar (Repository Corticotropin injection): 40 U (1.0 mL) twice/week


Group 3
  • Placebo

Outcomes
  • Complete or partial remission in proteinuria

  • Proportion of subjects that have sustained complete or partial remission

Notes
  • Estimated primary completion date: March 2013

  • Recruitment status; completed

  • No contact details on trial registry site, no publication when searched in Google Scholar