Clinical trial to assess the effect of SNF472 on progression of build up of calcium in coronary blood vessels in patients with kidney disease.

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; MedDRA version: 19.0 Level: PT Classification code 10051753 Term: Vascular calcification System Organ Class: 10047065 - Vascular disorders; MedDRA version: 19.0 Level: PT Classification code 10018875 Term: Haemodialysis System Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2016-002834-59-ES
• Lead Sponsor: aboratoris Sanifit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-26
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 450

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

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 < 5 years prior to randomisation. A history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed
6. pregnant or trying to become pregnant, currently breast-feeding, or of child-bearing potential (including peri-menopausal women who have had a menstrual period within one year) and not willing to practice birth control using a double barrier method (criteria apply to women only) at least 30 days post last dose of study medication
7. hypocalcaemia defined as a serum calcium below 8.0 mg/dL (or 2.0 mmol/L) for the serum calcium most proximal to screening per patient’s medical records
8. extreme elevation in serum phosphorous, defined as a phosphorous above 10 mg/dL (or 3.23 mmol/L) within the last 2 months proximal to screening per patient’s medical records
9. uncontrolled hypertension defined as any 2 or more consecutive post-dialysis DBP > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified