EUCTR2018-002751-15-GB进行中（未招募）1 期
A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 111
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
- 性别
- All
入选标准
- •-Informed of the investigational nature of the study and sign written informed consent
- •-Willing and able to adhere to all study-related procedures, including adherence to study medication regimen
- •-Male or female 18 years old and over
- •-End-stage renal disease on chronic haemodialysis
- •-Calciphylaxis with active skin lesions(s) of any morphological appearance (including but not limited to livedo, induration, ulceration etc.) and tissue histology review consistent with calciphylaxis diagnosis. Histological features consistent with calciphylaxis will include soft tissue calcification, microthrombosis and/or fibrointimal hyperplasia of dermal arterioles.
- •-Acute pain associated with calciphylaxis lesions with the worst non-evoked pain intensity score of greater than or equal to 5 at initial screening on the modified BPI/SF scale and for both of the 2 days preceding randomisation with the mean of the two scores greater than or equal to 6
- •-Females of childbearing potential must have a pregnancy test (urine or serum [if anuric]) at screening and not be pregnant and willing to use an acceptable method of contraception from screening through the last study visit (4 weeks): hormonal (oral pills, implant or injection) begun at time of screening, barrier (condom, diaphragm or cervical cap with spermicide), intrauterine device (IUD), abstinence (not having sex), being with the same sex partner or a partner who has had a vasectomy at least six months before the screening visit
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Peritoneal dialysis patients
- •-Current congestive heart failure exacerbation
- •-Baseline abnormalities related to QT prolongation (corrected QT interval >490 ms) or history of Torsade de Pointes, hypocalcaemia (serum albumin-corrected calcium < 8 mg/dL), metabolic acidosis (serum bicarbonate < 18 mmol/L), hypotension (resting systolic blood pressure while seated < 80) or interdialytic weight gain greater than or equal to 4% of body weight for patients whose body weight is over 100 kg.
- •-History of ventricular arrhythmias including ventricular fibrillation or ventricular tachycardia associated with shortness of breath, dizziness, hypotension or syncope
- •-Any prior (within the past 30 days) from the start of the screening visit or current intravenous Sodium Thiosulfate Injection treatment
- •-Other investigational agent (drug, biologic or device) study within the past 30 days from the start of the screening visit and/or for the duration of the trial
- •-Pregnant or lactating women
- •-History of allergy to sulfites, thiosulfate or any component in Sodium Thiosulfate Injection (sulfa allergy is not an exclusion criterion)
- •-Significant other acute or chronic concomitant diseases (including but not limited to hepatic, cardiovascular, pulmonary or oncologic disease, sepsis, pulmonary oedema, pulmonary embolism) that would be inconsistent with survival for at least 3 months from screening visit
- •-Other serious concurrent or recent medical or psychiatric condition which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study
- •-Ongoing application of dialysate admixed with iron salt e.g. ferric pyrophosphate during the entire trial period (patients who are on dialysate admixed with iron salt at screening are eligible if dialysate admixed with iron salt can be substituted with non-iron based dialysate and patients can be maintained on non-iron based dialysate therapy for the entire duration of trial period)
- •-Recent (within 1 week from the start of the screening visit) history of surgical parathyroidectomy or scheduled for surgical parathyroidectomy during the course of the study
- •-History of opioid addiction
- •-Significant clinical improvement by day 0 defined as > 50% improvement in the worst non-evoked pain intensity score in the preceding 24 hour period of run-in phase or > 50% improvement in skin lesions during the run-in phase as determined by clinical investigator
研究者
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