A prospective Multicenter Phase 2/3 Clinical Trial with Sodium Thiosulfate for the Treatment of Calciphylaxis

Dr. F. Köhler Chemie GmbH (Germany)0 个研究点目标入组 5 人开始时间: 2014年9月2日最近更新: 2020年6月8日

适应症

试验速览

暂无简介。

•1. All patients = 18 years
•2. Male or female hemodialysis (HD) patients with a diagnosis of calciphylaxis. (Patients on peritoneal dialysis or patients with the requirement for renal replacement therapy, who are diagnosed with calciphylaxis, may be switched to HD and included in the study after switching).
•3. Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study

•Current exclusion criteria as of 09/07/2018:
•1. Pregnant or lactating patients. As pregnancy is an extremely rare event in HD patients, a pregnancy test will only be performed in ambiguous cases.
•2. Patients who have participated in any other investigational studies within 30 days previous to enrolment
•3. History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment
•4. Good response to conventional treatment
•5. Life expectancy less than 4 months in the judgment of the investigator
•Previous exclusion criteria:
•1. Sodium metabisulfite hypersensitivity, among others the history of bronchial asthma due to known sodium metabisulfite hypersensitivity
•2. Pregnant or lactating patients. As pregnancy is an extremely rare event in HD patients, a pregnancy test will only be performed in ambiguous cases.
•3. Patients who have participated in any other investigational studies within 30 days previous to enrolment
•4. History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment
•5. Good response to conventional treatment
•6. Life expectancy less than 4 months in the judgment of the investigator

发起方

Dr. F. Köhler Chemie GmbH (Germany)