Phase 2 Open Label Single Arm Repeat Dose Study to Assess the Effect of SNF472 on Wound Healing in Uraemic Calciphylaxis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Wound Healing
研究概览
简要总结
To evaluate the effect of SNF472 on top of standard of care on promoting wound healing and other parameters of therapeutic response in haemodialysis patients with calciphylaxis (calcific uraemic arteriolopathy, CUA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with either newly diagnosed CUA OR recurrent CUA that has been dormant with no skin lesion involvement for at least 90 days from study start (new or recurrent diagnosis must be made within 5 weeks of study start)
- •Patients who signed the written informed consent to participate in this clinical trial (prior to any clinical trial-related procedures being performed), after reading the Patient Information Sheet and Informed Consent Form (ICF), and who had the opportunity to discuss the clinical trial with the Investigator or designee
- •Males or females aged ≥18
- •Patients on maintenance haemodialysis (HD)
- •Patients with at least a minimum level of pain on Visual Analog Scale (VAS) scale or on pain-killers stronger than non-steroidal anti-inflammatory drugs (NSAIDs)
- •Females of child-bearing potential should use a highly effective contraceptive measure throughout the study and have a negative serum pregnancy test at entry. Male patients having sexual relationship in which pregnancy can occur should take adequate contraceptive precautions (wear a condom)
排除标准
- •Body weight above 150 kg
- •BMI >35 and central(abdominal) ulcers
- •History of bisphosphonate treatment within 12 months before entering into the study
- •Severely ill patients without reasonable expectation of survival for > 6 months according to the treating physician
- •Patients with scheduled parathyroidectomy during the run-in or study period
- •Female patients who are either intending to get pregnant or are undergoing treatment to get pregnant, as well as breast-feeding females
- •Participation in another clinical trial with an experimental drug within 90 days prior the inclusion
- •Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the patient to comply with the Clinical Trial Protocol requirements
- •Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason
研究组 & 干预措施
SNF472
SNF472 for calciphylaxis
干预措施: SNF472 (Drug)
结局指标
主要结局
Wound Healing
时间窗: 12 weeks
Absolute change in Bates-Jensen Wound Assessment (BWAT) total score between baseline (Week 1) and Week 12 for the primary lesion (the largest one). The Bates-Jensen Wound Assessment (BWAT) is a standardized tool for quantitative assessment of wound healing that includes the 13 items listed below. * Size * Depth * Edges * Undermining or pockets * Necrotic tissue type * Necrotic tissue amount * Exudate type * Exudate amount * Surrounding skin color * Peripheral tissue edema * Peripheral tissue induration * Granulation tissue * Epithelialization Each item was rated on a scale of 1 (best) to 5 (worst). The Bates-Jensen Wound Assessment (BWAT) total score is the sum of the individual items with a possible range of 13 (best) to 65 (worst).
次要结局
- Wound-QoL Global Score(12 weeks)
- Wound Pain(12 weeks)