Phase 2 Open Label Study of SNF472 in Calciphylaxis Patients
Research type
Research Study
Full title
Phase 2 Open Label Single Arm Repeat Dose Study to Assess the Effect\nof SNF472 on Wound Healing in Uraemic Calciphylaxis Patients
IRAS ID
207062
Contact name
Ana-Zeralda Canals Hamann
Contact email
Sponsor organisation
Laboratoris Sanifit SL
Eudract number
2015-004313-25
Duration of Study in the UK
0 years, 9 months, 17 days
Research summary
Phase 2 Study to Assess the Effect of SNF472 on Wound Healing in Uraemic Calciphylaxis Patients\n\nThe new medicine (the study drug) tested in this study is a compound called SNF472. The study drug is developed for the prevention of the progression of cardiovascular calcification, potentially stopping the deposition of calcium into the blood vessels and the heart itself in patients with end-stage kidney disease undergoing haemodialysis and for calciphylactic patients.\n \nThe main purpose of this study is to see how the drug can potentially help heal the calciphylaxis wounds quicker in patients undergoing haemodialysis. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. All patients who have signed the informed consent form and fulfill all inclusion criteria and none of the exclusion criteria will receive the study drug during their ordinary dialysis sessions 3 times per week during 12 weeks.\n\nThe study is funded by Laboratoris Sanifit and patients will be recruited in Europe and in the USA. \n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0428
Date of REC Opinion
29 Jun 2016
REC opinion
Further Information Favourable Opinion