Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Cardiovascular Diseases, Cardiovascular Abnormalities, Calcifications, Vascular, Endstage Renal Disease, ESRD, Coronary Artery Calcification

In brief

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 coronary artery calcium volume score over a 12-month (52 weeks) period in ESRD patients on HD

Key facts

Study ID

NCT02966028

Run by

Sanifit Therapeutics S. A.

People needed

274

Starts

2016-11-01

Expected to finish

2019-09-01

Last updated by the study team

2021-04-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or male patients, 18 to 80 years (inclusive) of age at randomisation
• CAC score of 100 to 3500 AU (Agatston Units) inclusive within a 3-week period prior to randomisation as measured by a multi-detector CT scanner
• Patients who are EITHER ≥ 55 years OR have a history of diabetes mellitus at randomisation
• Patients on HD for ≥ 6 months prior to randomisation
• Willing and able to understand and sign the informed consent

You may not qualify if…

• Scheduled date for kidney transplant from a known living donor
• Weight above 300 lbs (136 kg)
• Hospitalisation in the previous 3 months prior to randomisation for unstable angina, MI, stroke, transient ischaemic attack, amputation or peripheral or coronary bypass surgery
• 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
• 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
• 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
• 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
• Extreme elevation in serum phosphorous, defined as a serum phosphorous above 10 mg/dL (or 3.23 mmol/L) within the last 2 months proximal to screening per patient's medical records
• Uncontrolled hypertension defined as any 2 or more consecutive post-dialysis diastolic blood pressure (DBP) > 100 mmHg within the last 2 months proximal to screening expected survival < 2 years in the Investigator's medical opinion
• Known active drug or alcohol abuse within 1 year of randomisation
• Use of other investigational drugs within 30 days of randomisation
• 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
• 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

Where it is running

• Study site — Chula Vista, California, United States
• Study site — Escondido, California, United States
• Study site — Granada Hills, California, United States
• Study site — La Palma, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Lynwood, California, United States
• Study site — Northridge, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — San Dimas, California, United States
• Study site — Simi Valley, California, United States
• Study site — Tarzana, California, United States
• Study site — Whittier, California, United States
• Study site — Arvada, Colorado, United States
• Study site — Westminster, Colorado, United States
• Study site — Middlebury, Connecticut, United States
• Study site — Orange, Connecticut, United States
• Study site — Hollywood, Florida, United States
• Study site — Lauderdale Lakes, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Gardens, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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