SNFCT2017-06
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When added to Background Care for the Treatment of Calciphylaxis.
IRAS ID
1003230
Contact name
Smeeta Sinha
Contact email
Sponsor organisation
Sanifit Therapetics S.A
Eudract number
2018-001301-90
Research summary
This study will evaluate the efficacy and safety of the study drug SNF472 compared with
placebo in treating calciphylaxis in patients on dialysis when taken in addition to
background treatment for calciphylaxis.
The planned enrolment is approximately 66 subjects worldwide.
Each subject will be enrolled in the study for up to 33 weeks which will include 5 weeks
of screening (performing medical tests and results review to assess suitability), 12 weeks
of treatment (placebo-controlled), 12 weeks of further treatment (open-label) followed by
4 weeks of follow-up.
The treatment will be divided in 2 parts. In Part 1 the subjects will be randomly assigned
(like flipping a coin) to receive either SNF472 or the placebo (no active drug). This will
be double-blinded which means neither the subject, study doctor or study nurse will know
whether the study drug contains SNF472 or placebo. Subjects will receive the study drug
3 times a week for 12 weeks.
Part 2 will be open-label, all subjects will receive the SNF472 3 times a week for 12
weeks.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0183
Date of REC Opinion
20 May 2020
REC opinion
Further Information Favourable Opinion