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).
23 studies on the registry are indexed under Calciphylaxis; 10 are open to participants now.
This study's enrollment of 14 is below the median of 28 across 12 interventional studies indexed under Calciphylaxis.
Browse Calciphylaxis studies →Sanifit Therapeutics S. A. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2016 to primary completion in Nov 2017, 18 months.
Results were first posted in Aug 2019, 1 year 9 months after primary completion.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SNF472
Sanifit Therapeutics S. A.