Calciphylaxis Circulatory System
Conditions
Interventions
The study will involve 40 female and male patients. At start of the run-in phase (VR) of 2 to 4 weeks, patients will be treated with conventional medications and measures. If the investigators assess
Sponsors
Dr. F. Köhler Chemie GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Status of skin lesions: 1. Total wound area at 8, 16, 36, 48 weeks compared to baseline (V0). 2. Complete remission of wound area. 3. Qualitative improvement of skin lesions at 8, 16, 24, 36, 48 weeks as assessed by the revised Photographic Wound Assessment Tool (revPWAT) score and evaluation of a serial photo documentation through 2 independent, blinded dermatologists. 4. Use of wound debridement Pain: 5. Reduction of pain in the areas of calciphylaxis after 4, 8, 16, 24, 36 and 48 weeks after start of STS treatment will be compared to baseline (V0) and assessed by a visual analogue scale (VAS) for pain (0-10). This will be done directly before changing the wound dressing. 6. Consumption of pain medication (normalized to morphine equivalent with an appropriate conversion table) will be assessed at V0 and 4, 8, 16, 24, 36 and 48 weeks after start of STS treatment and compared to baseline (V0). Clinical global impression: 7. Change in clinical global impression as assessed by the Clinical Global Impressions Improvement (CGI-I) score at each follow-up visit (after 4, 8, 16, 24, 36 and 48 weeks) compared to baseline (V0) and the Clinical Global Impression-Severity scale (CGI-S) through the investigators. The Clinical Global Impression-Severity scale (CGI-S) will be assessed at each visit from visit V0 to V6 (i.e. after 4, 8, 16, 24, 36 and 48 weeks). Improvement leading to eligibility of the patient for kidney transplantation: 8. Eligibility for kidney transplantation is given when the patient is being actively listed on a transplant waiting list. Occurrence of new lesions: 9. Time point of occurrence and ? if applicable ? healing as well as location of each lesion to be documented at each visit (V0 to V6) Bone mineral density (BMD): | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactAgnes Putz
Outcome results
None listed