Phase 3 Study of SNF472 for Calciphylaxis

Completed · Phase 3 · Has a placebo group

Conditions studied: Calciphylaxis, Calcific Uremic Arteriolopathy

In brief

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).

Key facts

Study ID

NCT04195906

Run by

Sanifit Therapeutics S. A.

People needed

71

Starts

2020-02-12

Expected to finish

2022-10-24

Last updated by the study team

2024-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 receipt of an investigational drug or investigational use of a licensed drug within 30 days prior to screening.
• History or presence of active alcoholism or drug abuse as determined by the Investigator within 6 months
• Mental impairment, current significant psychiatric disease, or other conditions or circumstances that would make the subject unlikely to complete the study or comply with the study procedures.
• Subjects whose CUA lesions exhibit significant improvement, in the opinion of the Investigator, between the first and second screening visit

Where it is running

• California Institute of Renal Research — El Centro, California, United States
• California Institute of Renal Research — Escondido, California, United States
• Kidney Disease Medical Group — Glendale, California, United States
• DaVita Clinical Research — Lynwood, California, United States
• Apex Research of Riverside — Riverside, California, United States
• Fresenius Kidney Care — San Diego, California, United States
• North America Research Institute — San Dimas, California, United States
• Amicis Research Center — Vacaville, California, United States
• Colorado Kidney Care — Denver, Colorado, United States
• Boca Nephrology, PA — Boca Raton, Florida, United States
• DaVita Clinical Research — Hollywood, Florida, United States
• Novel Outcomes Research — Spring Hill, Florida, United States
• DaVita Clinical Research — Tampa, Florida, United States
• Fresenius Kidney Care — Tampa, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Michigan Kidney Consultants — Pontiac, Michigan, United States
• DaVita Clinical Research — Roseville, Michigan, United States
• DaVita Clinical Research — Minneapolis, Minnesota, United States
• Fresenius Kidney Care — Brookhaven, Mississippi, United States
• DaVita Clinical Research — Kansas City, Missouri, United States
• DaVita Clinical Research — Las Vegas, Nevada, United States
• Fresenius Kidney Care — Reno, Nevada, United States
• DaVita Clinical Research — The Bronx, New York, United States
• DaVita Clinical Research — Asheville, North Carolina, United States
• AKDHC Medical Research Services — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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