Cardiovascular calcification in blood vessels in end-stage-renal-disease (ESRD) patients on haemodialysis (HD). MedDRA version: 19.0 Level: LLT Classification code 10014646 Term: End stage renal disease (ESRD) System Organ Class: 100000004857 MedDRA version: 19.0 Level: PT Classification code 10051753 Term: Vascular calcification Syste
Conditions
Interventions
Product Name: SNF472
Product Code: SNF472
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Myo-inositol hexaphosphate (IP6, phytate)
Sponsors
Laboratoris Sanifit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. female or male patients, 18 to 80 years (inclusive) of age at randomisation 2. CAC score of 100 to 2000 AU inclusive within a 3-week period prior to randomisation, as measured by a multi-detector CT scanner 3. patients who are EITHER = 55 years OR have a history of diabetes mellitus at randomisation 4. patients on HD for = 6 months prior to randomisation 5. willing and able to understand and sign the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: 1. scheduled date for kidney transplant from a known living donor 2. weight above 300 lbs (136 kg) 3. hospitalisation in the previous 3 months prior to randomisation for unstable angina, MI, stroke, transient ischaemic attack, amputation or peripheral or coronary bypass surgery 4. history of unstable heart failure in the previous 3 months, defined as an unplanned presentation to a hospital or dialysis treatment facility with signs/symptoms of acute pulmonary edema and requiring ultrafiltration therapy 5. history of cancer that has been in remission for 100 mmHg within the last 2 months proximal to screening 10. expected survival < 2 years in the Investigator’s medical opinion 11. known active drug or alcohol abuse within 1 year of randomisation 12. use of other investigational drugs within 30 days of randomisation 13. non-compliance with dialysis treatment which, in the opinion of the Investigator, evidenced by either repeated missed dialysis treatments or significant non-compliance with the patient’s medication regimen 14. Inability to comply with all required study procedures and schedule, inability to speak and read in the protocol-derived language of that patient's clinical site, or unwillingness or inability to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the absolute change in coronary artery calcium volume scores measured by CT scan.;Timepoint(s) of evaluation of this end point: Baseline (Week 1, Day 1) and Week 52;Main Objective: The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg) compared to placebo on the progression of absolute change in coronary artery calcium volume score over a 12 month (52 weeks) period in ESRD patients on HD.; Secondary Objective: The secondary objectives are to: •assess change in percent change from baseline (Week 1, Day 1) in coronary artery calcium volume score •assess changes in absolute and percentage change from baseline (Week 1, Day 1) in coronary artery calcium (CAC)/Agatston score •assess the number of patients with <15% progression in CAC/Agatston score •assess the change from baseline in thoracic aorta calcification score •assess the change from baseline in aortic valve calcification score •assess composite safety endpoint of death, myocardial infarction (MI), stroke, and heart failure •assess biomarkers as early signals for treatment efficacy/response •assess changes in bone mineral density (BMD) •describe the long-term safety profile of SNF472 in this target population | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • percentage change from baseline in calcium volume score at Week 52 • absolute change from baseline in CAC/Agatston score at Week 52 • percentage change from baseline in CAC/Agatston score at Week 52 • number of patients with <15% progression in CAC/Agatston score at Week 52 • change from baseline in thoracic aorta calcification score at Week 52 • change from baseline in aortic valve calcification score at Week 52 • incidence of composite safety endpoint that include CV death (not all-cause), MI, stroke, and heart failure • mortality rate (all-cause and CV) • change from baseline in levels of selected biomarkers The endpoints above will be analysed as efficacy as well as safety endpoints. The following secondary safety endpoints will be analysed: • changes in BMD levels between baseline and Week 52 • safety of SNF472 in terms of adverse event (AE) and SAE incidences ;Timepoint(s) of evaluation of this end point: Week 52 | — |
Countries
Ireland, Italy, Spain, United Kingdom, United States
Contacts
Public ContactProject Manager/CRA
Accovion, S.L.
Outcome results
None listed