SNFCT2015-05
Research type
Research Study
Full title
A double-blind, randomised, placebo-controlled study to assess the effect of SNF472 on progression of cardiovascular calcification on top of standard of care in end-stage-renal-disease (ESRD) patients on haemodialysis (HD)
IRAS ID
213429
Contact name
Smeeta Sinha
Contact email
Sponsor organisation
Laboratoris Sanifit
Eudract number
2016-002834-59
Clinicaltrials.gov Identifier
116437, IND Number
Duration of Study in the UK
years, 30 months, 0 days
Research summary
The main goal of this research study is to find out if the investigational study drug called SNF472 will have any effect on people whose kidneys are not working normally and need routine dialysis. \nResearchers want to learn more about any side effects that may be experienced while being given the study drug. \nOne of the effects when your kidneys are not working normally is the build-up of calcium within your blood vessels that make them stiff, especially those near your heart. This collection of calcium increases your risk of developing serious heart problems. The study drug is thought to slow down or prevent the build-up of more calcium in your blood vessels.\nEnrolled patients will receive either SNF472 or a placebo. The placebo looks like SNF472 but has no active ingredient (contains only saline solution). Both SNF472 and the placebo will be referred to as study drug.\nUp to 450 adult patients (between 18 and 80years old) from about 75 study centers in USA and Europe will be asked to join the study. If they qualify, participation in the study will last for about 59 weeks. This will include a 3-week screening period where the Study Doctor will confirm eligibility to participate in this study. The screening period is followed by a 52-week study treatment period where subjects will receive the study drug through the dialysis machine during routine dialysis visits. There will be a follow up visit about 4 weeks after the last dose of the study drug.\n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0726
Date of REC Opinion
28 Nov 2016
REC opinion
Further Information Favourable Opinion