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

Phase 1

• Conditions: Calciphylaxis; MedDRA version: 20.0Level: PTClassification code 10051714Term: CalciphylaxisSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-002128-28-DE
• Lead Sponsor: Dr. F. Köhler Chemie GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-21
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

(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

Exclusion Criteria

(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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Percent reduction of the total wound area after 24 weeks (V4) compared to baseline (V0) as assessed by 2 independent, blinded dermatologists using a serial photo documentation. The mean value of both assessments will be taken.;Secondary Objective: Status of skin lesions, Pain, Clincal Global Impression, Improvement leading to eligibility of the patient for kidney transplantation, New Lesions, Bone Mineral Density, Survival, Safety Parameters.;Primary end point(s): See section E2.1 Primary Objectives;Timepoint(s) of evaluation of this end point: after 24 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): See section E2.2 Secondary Objectives;Timepoint(s) of evaluation of this end point: at 4, 8, 16, 24, 36, 48 weeks