Wound Healing in Uraemic Calciphylaxis MedDRA version: 20.0 Level: PT Classification code 10051714 Term: Calciphylaxis System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: SNF472
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: hexasodium phytate
CAS Number: 34367-89-0
Sponsors
Laboratoris Sanifit SL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed calciphylaxis (diagnosed within 3 weeks of study start) 2. Patients who signed the written informed consent to participate in this clinical trial (prior to any clinical trial-related procedures being performed), after reading the Patient Information Sheet and Informed Consent Form (ICF), and who had the opportunity to discuss the clinical trial with the Investigator or designee 3. Males or females aged =18 4. Patients on maintenance haemodialysis 5. Patients with a minimum level of pain on VAS scale or on pain-killers stronger than NSAIDs 6. Females of child-bearing potential should use a highly effective contraceptive measure throughout the study AND have a negative serum pregnancy test at entry. Male patients having sexual relationship in which pregnancy can occur should take adequate contraceptive precautions (wear a condom) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Body weight above 150 kg 2. BMI >35 and central(abdominal) ulcers 3. History of bisphosphonate treatment within 12 months before entering into the study 4. Patients being anticoagulated with citrate 5. Severely ill patients without reasonable expectation of survival for > 6 months according to the treating physician 6. Patients with scheduled parathyroidectomy during the run-in or study period 7. Female patients who are either intending to get pregnant or are undergoing treatment to get pregnant, as well as breast-feeding females 8. Participation in another clinical trial with an experimental drug within 90 days prior the inclusion 9. Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the patient to comply with the Clinical Trial Protocol requirements 10. Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Weeks 1, 2, then 4, 6, 8, 10, 12 and EOS (FU) visit; Main Objective: To evaluate the effect of SNF472 on top of standard of care on promoting wound healing and other parameters of therapeutic response in haemodialysis patients with calciphylaxis ;Secondary Objective: Not applicable; Primary end point(s): The primary lesion is the largest one - based on longitudinal and transverse measurements - and the one to be followed through imaging throughout the duration of the study by taking pictures of the lesion - A maximum of 3 lesions - including the primary one - will be thoroughly assessed during the study - Lesion score (Bates Jensen Assessment tool) will be performed during Weeks 1, 2, then 4, 6, 8, 10, 12 and EOS (FU) visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Wound infection, both for the primary and the secondary lesions - Systemic infection - Surgical treatment of the wound - Hospitalisation defined as being admitted for >24 hours - Course of the secondary lesions defined clinically as for the primary - Change in pain from week 0 to 12 according to 100 mm Visual Analog Pain Scale (VAS) - Pain scale done at Screening, weeks 1, 2, 4, 6, 8, 10, 12 and EOS(FU) visit * Change in dose and type of pain medication assessed as a continuous variable. Name, dose and number of pills captured. - Wound QOL score - Death ; Timepoint(s) of evaluation of this end point: 1. Pain Score: at Screening, weeks 1, 2, 4, 6, 8, 10, 12 and EOS (FU) visit 2. Wound QoL Score: at Screening (for training purposes) and weeks 1, 6 and 12 | — |
Countries
Germany, Spain, United Kingdom, United States
Contacts
Public ContactCanals Hamann
Laboratoris Sanifit SL
Outcome results
None listed