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

Dr. F. Köhler Chemie GmbH0 个研究点目标入组 40 人开始时间: 2014年11月21日最近更新: 2018年6月18日

适应症

试验速览

暂无简介。

•(1)All patients = 18 years
•(2)Male or female 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
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•(1)Females who are pregnant (positive pregnancy test at screening or during study phase), lactating, or if having reproductive potential (being not post-menopausal (no menses for 12 months without an alternative medical cause) or surgically sterilized) are considered potentially ineligible with respect to use highly effective methods of birth control throughout the study, which are also desribed in detail in the Patient Inform Consent Form (Of note, STS has been demonstrated not to cross the blood-placenta barrier in gravid eves (Graeme et al., 1999); therefore we regard fetal damage also as unlikely in humans).
•(2)Patients who have participated in any other investigational studies within 30 days previous to enrollment
•(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 judgement of the investigator

发起方

Dr. F. Köhler Chemie GmbH