Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD)… (NCT02966028) | Clinical Trial Compass
CompletedPhase 2
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
United States274 participantsStarted 2016-11
Plain-language summary
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
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Hypoc…
What they're measuring
1
Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo