Clinical Trial: Phase 2 Study With SNF472 in Calciphylaxis Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 2 Open Label Single Arm Repeat Dose Study to Assess the Effect of SNF472 on Wound Healing in Uraemic Calciphylaxis Patients

Brief Summary: To evaluate the effect of SNF472 on top of standard of care on promoting wound healing and other parameters of therapeutic response in haemodialysis patients with calciphylaxis (calcific uraemic arteriolopathy, CUA).

Detailed Summary:
Sponsor: Laboratoris Sanifit

Current Primary Outcome:

  • Progression of 3 lesions, including primary lesion by collecting images of lesions [ Time Frame: During 12 weeks ]
  • Assessment of lesion score using Bates-Jensen wound assessment tool [ Time Frame: During 12 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Assessment of wound infection (absence or presence) [ Time Frame: During 12 weeks ]
    For the primary and the secondary lesions
  • Assessment of systemic infection (absence or presence) [ Time Frame: During 12 weeks ]
  • Surgical treatment of the wound [ Time Frame: During 12 weeks ]
    Collection of surgical treatments performed of the wound
  • Hospitalisation defined as being admitted for >24 hours [ Time Frame: During 12 weeks ]
  • Course of the secondary lesions defined clinically as for the primary lesion [ Time Frame: During 12 weeks ]
    By collecting images of the secondary lesions, assessing the progression of the lesions during treatment
  • Change in pain according to Pain Visual Analogue Scale (VAS) [ Time Frame: During 12 weeks ]
  • Change in dose and type of pain medication [ Time Frame: During 12 weeks ]
    Documenting name, dose and number of pills
  • Assess quality of life (QOL) based on wound QOL score [ Time Frame: During 12 weeks ]
  • Death [ Time Frame: During 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Laboratoris Sanifit

Dates:
Date Received: May 25, 2016
Date Started: May 2016
Date Completion: December 2017
Last Updated: March 22, 2017
Last Verified: March 2017