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).
The formation and growth of calcified deposits in arterioles and other small blood vessels appears to be fundamental to the development of CUA especially in end stage renal disease patients. This phase 3 double-blind, randomized, placebo-controlled study is designed to assess the effect of SNF472 when added to background care to improve wound healing, as evaluated using Bates-Jensen Wound Assessment Tool (BWAT) scoring and pain as reported by the subject using a VAS scale. The study consists of a double-blind, randomized, placebo controlled period of 12 weeks followed by an open-label period of 12 weeks.. .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
71
Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks
Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions fo 12 weeks
Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks
Absolute Change in the BWAT - CUA Score for the Primary Lesion
The Bates Jensen Wound Assessment Tool (BWAT) CUA score ranges from a minimum score of 8 (best) to a maximum score of 40 (worst). BWAT-CUA= Bates-Jensen Wound Assessment Tool-Calcific Uremic Arteriolopathy
Time frame: from Baseline to Week 12
Absolute Change in Pain Visual Analog Score
The Pain Visual Analog Scale (VAS) score ranges from a minimum score of 0 (no pain) to 100 (worst possible pain).
Time frame: from Baseline to Week 12
Absolute Change in the Wound-Quality of Life Score
The Wound Quality of Life scale is a validated self-assessment tool that has been shown to be feasible for assessing health-related quality of life in patients with chronic wounds. Lower scores are associated with a better quality of life as reported by the patient. The score is computed by averaging the 17 items on impairments assessed on a scale of 0 to 4 for the preceding 7 days. A global score can only be computed if at least 75% of the items have been answered, i.e., at least 13 in 17 items are valid. All the available items' scores were added up and divided by 17. In case of missing assessments for any one of the 17 items, the median of the scores for a particular item within the associated randomized treatment group was used for the imputation purposes. As the absolute change from baseline is reported, a higher negative value is associated with a higher improvement of quality of life.
Time frame: from Baseline to Week 12
Absolute Change in the BWAT Total Score for the Primary Lesion
The Bates Jensen Wound Assessment Tool (BWAT) score ranges from a minimum score of 9 (best) to a maximum score of 65 (worst) score.
Time frame: from Baseline to Week 12
Qualitative Wound Image Evaluation for the Primary Lesion
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AKDHC Medical Research Services
Phoenix, Arizona, United States
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
...and 48 more locations
A qualitative assessment (Worsened, Equal to, or Improved Relative to Baseline) was assigned
Time frame: at Week 12
Rate of Change in Opioid Use as Measured in Morphine Milligram Equivalents (MME)
Change from baseline in opioid use MME = Morphine Milligram Equivalents The calculation of the pre-specified list of opioids was based on the formula: strength per unit × (number of units/days supply) × MME conversion factor = MME/day, as specified in the opioid MME conversion guide (CMS, 2017). The maintenance opioid dose was defined as the average daily opioid dose in MME during the 7-day period prior to Screening Visit 2. To assess the extent to which opioid use may have differed between randomized treatment groups over time, the change from baseline in daily average MME value was analyzed.
Time frame: from Baseline to Week 12