Phase 3 Study of SNF472 for Calciphylaxis (NCT04195906) | Clinical Trial Compass
CompletedPhase 3
Phase 3 Study of SNF472 for Calciphylaxis
United States71 participantsStarted 2020-02-12
Plain-language summary
The primary objectives are to assess the efficacy, safety, and tolerability of SNF472 compared to placebo when added to background care for the treatment of calciphylaxis (CUA).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female or male subjects, 18 years of age or older
* Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening
* Clinical diagnosis of CUA by the Investigator including ≥1 CUA lesion with ulceration of the epithelial surface
* CUA wound-related pain shown by a Pain VAS score ≥50 out of 100
* Primary lesion that can be clearly photographed for the purpose of protocol-specified wound healing assessments.
* Willing and able to understand and sign the informed consent form and willing to comply with all aspects of the protocol
Exclusion Criteria:
* History of treatment with bisphosphonates within 3 months of baseline
* Severely ill subjects without a reasonable expectation of survival for at least 6 months
* Subjects with a scheduled parathyroidectomy during the study period
* Expectation for kidney transplant within the next 6 months based on Investigator assessment or identification of a known living donor
* Pregnant or trying to become pregnant, currently breastfeeding, or of childbearing potential (including perimenopausal women who have had a menstrual period within one year) and not willing to comply with protocol required contraception criteria
* Significant noncompliance with dialysis
* History of active malignancy within the last year with the exception of localized basal cell or squamous cell carcinoma
* Clinically significant illness other than CUA within 30 days
* Participation in an investigational study and receip…
What they're measuring
1
Absolute Change in the BWAT - CUA Score for the Primary Lesion