A Phase 2 interventional study of SNF472 in Calciphylaxis and Calcific Uremic Arteriolopathy, sponsored by Sanifit Therapeutics S. A.. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Sanifit Therapeutics S. A. · Phase 2, Interventional, and Treatment
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 (calcific uraemic arteriolopathy, CUA).
Exclusion Criteria:
SNF472 for calciphylaxis
Drug: SNF472
SNF472 for calciphylaxis
Wound Healing
Absolute change in Bates-Jensen Wound Assessment (BWAT) total score between baseline (Week 1) and Week 12 for the primary lesion (the largest one). The Bates-Jensen Wound Assessment (BWAT) is a standardized tool for quantitative assessment of wound healing that includes the 13 items listed below. * Size * Depth * Edges * Undermining or pockets * Necrotic tissue type * Necrotic tissue amount * Exudate type * Exudate amount * Surrounding skin color * Peripheral tissue edema * Peripheral tissue induration * Granulation tissue * Epithelialization Each item was rated on a scale of 1 (best) to 5 (worst). The Bates-Jensen Wound Assessment (BWAT) total score is the sum of the individual items with a possible range of 13 (best) to 65 (worst).
Time frame: 12 weeks
Wound Pain
Absolute change from baseline (Week 1) and Week 12 in the Pain Visual Analogue Scale (VAS) Score. The Pain Visual Analogue Scale (VAS) Score is a horizontal line, 100 mm in length, anchored by word descriptors at each end. The subject marked the point on the line that represented his/her perception of his/her current pain status. The Pain Visual Analogue Scale (VAS) Score was determined by measuring in millimeters from the left hand end of the line (no pain) to the point that the subject marked. The Pain Visual Analogue Scale (VAS) Score range 0 (best) to 100 (Worst).
Time frame: 12 weeks
Wound-QoL Global Score
Absolute change from baseline (Week 1) and Week 12 in the Wound-QoL global score. The Wound-QoL questionnaire measures the disease-specific, health related QoL of patients with chronic wounds. It consists of 17 items on impairments that are assessed in retrospect to the preceding 7 days and rated on a 0 (best) to 4 (worse) scale with possible responses from "not at all" to "very much". The total score is the average of the 17 responses.
Time frame: 12 weeks
| Milestone | SNF472 |
|---|---|
| Started | 14 |
| Completed | 11 |
| Not completed | 3 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal from hd | 1 |
| Withdrew: Withdrawal by subject | 1 |
Absolute change in Bates-Jensen Wound Assessment (BWAT) total score between baseline (Week 1) and Week 12 for the primary lesion (the largest one). The Bates-Jensen Wound Assessment (BWAT) is a standardized tool for quantitative assessment of wound healing that includes the 13 items listed below. * Size * Depth * Edges * Undermining or pockets * Necrotic tissue type * Necrotic tissue amount * Exudate type * Exudate amount * Surrounding skin color * Peripheral tissue edema * Peripheral tissue induration * Granulation tissue * Epithelialization Each item was rated on a scale of 1 (best) to 5 (worst). The Bates-Jensen Wound Assessment (BWAT) total score is the sum of the individual items with a possible range of 13 (best) to 65 (worst).
| units on a scale | SNF472 |
|---|---|
| Wound Healing | -8.1 ± 8.5 |
Absolute change from baseline (Week 1) and Week 12 in the Pain Visual Analogue Scale (VAS) Score. The Pain Visual Analogue Scale (VAS) Score is a horizontal line, 100 mm in length, anchored by word descriptors at each end. The subject marked the point on the line that represented his/her perception of his/her current pain status. The Pain Visual Analogue Scale (VAS) Score was determined by measuring in millimeters from the left hand end of the line (no pain) to the point that the subject marked. The Pain Visual Analogue Scale (VAS) Score range 0 (best) to 100 (Worst).
| units on a scale | SNF472 |
|---|---|
| Wound Pain | -23.6 ± 30.0 |
Absolute change from baseline (Week 1) and Week 12 in the Wound-QoL global score. The Wound-QoL questionnaire measures the disease-specific, health related QoL of patients with chronic wounds. It consists of 17 items on impairments that are assessed in retrospect to the preceding 7 days and rated on a 0 (best) to 4 (worse) scale with possible responses from "not at all" to "very much". The total score is the average of the 17 responses.
| units on a scale | SNF472 |
|---|---|
| Wound-QoL Global Score | -0.9 ± 0.87 |
Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SNF472 | 2/14 (14.3%) | 7/14 (50%) | 13/14 (92.9%) |
| Event | SNF472 |
|---|---|
| Cardio-respiratory arrestCardiac disorders | 1/14 |
| Cardiogenic shockCardiac disorders | 1/14 |
| HaematemesisGastrointestinal disorders | 1/14 |
| CellulitisInfections and infestations | 1/14 |
| GangreneInfections and infestations | 1/14 |
| InfectionInfections and infestations | 1/14 |
| SepsisInfections and infestations | 1/14 |
| Urinary tract infectionInfections and infestations | 1/14 |
| Abdominal wound dehiscenceInjury, poisoning and procedural complications | 1/14 |
| Fluid overloadMetabolism and nutrition disorders | 1/14 |
| Event | SNF472 |
|---|---|
| DiarrhoeaGastrointestinal disorders | 2/14 |
| NauseaGastrointestinal disorders | 2/14 |
| Arteriovenous fistula thrombosisInjury, poisoning and procedural complications | 2/14 |
| Electrocardiogram QT prolongedInvestigations | 2/14 |
| HypoaesthesiaNervous system disorders | 2/14 |
| Skin lesionSkin and subcutaneous tissue disorders | 2/14 |
| HypertensionVascular disorders | 2/14 |
| TachycardiaCardiac disorders | 1/14 |
| VertigoEar and labyrinth disorders | 1/14 |
| DyspepsiaGastrointestinal disorders | 1/14 |
| Age, Continuous(years) | SNF472 |
|---|---|
| Mean | 60.5 ± 14.1 |
| Sex: Female, Male(Participants) | SNF472 |
|---|---|
| Female | 11 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | SNF472 |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | SNF472 |
|---|---|
| United States | 13 |
| United Kingdom | 1 |
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Sanifit Therapeutics S. A.