EUCTR2016-002834-59-GB进行中（未招募）1 期
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)
Sanifit Therapeutics S.A.0 个研究点目标入组 270 人开始时间: 2016年9月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. female or male patients, 18 to 80 years (inclusive) of age at randomisation
- •2. CAC score of 100 to 3500 AU inclusive within a 4-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 162
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 108
排除标准
- •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
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