A clinical trial with Sodium Thiosulfate for the treatment of Calciphylaxis

Phase 2

Completed

• Conditions: Calciphylaxis; Circulatory System

• Registration Number: ISRCTN73380053
• Lead Sponsor: Dr. F. Köhler Chemie GmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-02
• Study Completion: 2018-05-30
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.