A Phase 3 interventional study of Experimental: SNF472 and Placebo Comparator: Placebo in Calciphylaxis and Calcific Uremic Arteriolopathy, sponsored by Sanifit Therapeutics S. A.. Completed at 58 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Sanifit Therapeutics S. A. · Phase 3, Interventional, and Treatment
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.. .
23 studies on the registry are indexed under Calciphylaxis; 10 are open to participants now.
This study's enrollment of 71 is above 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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.
Drug: Experimental: SNF472
Matching placebo (saline) diluted in 100 mL physiological saline.
Drug: Placebo Comparator: Placebo
Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.
Drug: Experimatenl SNF472 (Open-label)
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
Also known as: Saline
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
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
| Milestone | SNF472 (Double-blind Period + Open-label) | Placebo (Double-blind Period) + SNF472 (Open-label) |
|---|---|---|
| Started | 37 | 34 |
| Completed | 34 | 26 |
| Not completed | 3 | 8 |
| Withdrew: Adverse event | 3 | 7 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | SNF472 (Double-blind Period + Open-label) | Placebo (Double-blind Period) + SNF472 (Open-label) |
|---|---|---|
| Started | 34 | 26 |
| Completed | 32 | 19 |
| Not completed | 2 | 7 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Other | 1 | 3 |
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
| score on a scale | SNF472 | Placebo |
|---|---|---|
| Absolute Change in the BWAT - CUA Score for the Primary Lesion | -5.3 ± 5.18 | -6.0 ± 6.17 |
The Pain Visual Analog Scale (VAS) score ranges from a minimum score of 0 (no pain) to 100 (worst possible pain).
| score on a scale | SNF472 | Placebo |
|---|---|---|
| Absolute Change in Pain Visual Analog Score | -19.5 ± 26.89 | -32.2 ± 38.53 |
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.
| score on a scale | SNF472 | Placebo |
|---|---|---|
| Absolute Change in the Wound-Quality of Life Score | -0.67 ± 0.798 | -0.74 ± 1.175 |
The Bates Jensen Wound Assessment Tool (BWAT) score ranges from a minimum score of 9 (best) to a maximum score of 65 (worst) score.
| score on a scale | SNF472 | Placebo |
|---|---|---|
| Absolute Change in the BWAT Total Score for the Primary Lesion | -11.0 ± 9.85 | -11.7 ± 12.23 |
A qualitative assessment (Worsened, Equal to, or Improved Relative to Baseline) was assigned
| Participants | SNF472 | Placebo |
|---|---|---|
| Worsened | 6 | 7 |
| Equal | 0 | 1 |
| Improved | 23 | 18 |
| Missing | 8 | 8 |
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.
| MME/week | SNF472 | Placebo |
|---|---|---|
| Rate of Change in Opioid Use as Measured in Morphine Milligram Equivalents (MME) | 0.46 ± 0.461 | -0.11 ± 0.499 |
Collected over Part 1: 12-week double-blind, randomized, placebo-controlled treatment period Part 2: 12-week open-label treatment period after completion of part 1 period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SNF472 - Safety Analysis Population (Part 1) | 1/38 (2.6%) | 13/38 (34.2%) | 27/38 (71.1%) |
| Placebo - Safety Analysis Population (Part 1) | 6/33 (18.2%) | 17/33 (51.5%) | 21/33 (63.6%) |
| SNF472 Open Label - Safety Analysis Population (Part 2) | 1/60 (1.7%) | 18/60 (30%) | 33/60 (55%) |
| Event | SNF472 - Safety Analysis Population (Part 1) | Placebo - Safety Analysis Population (Part 1) | SNF472 Open Label - Safety Analysis Population (Part 2) |
|---|---|---|---|
| CalciphylaxisMetabolism and nutrition disorders | 2/38 | 5/33 | 1/60 |
| CellulitisInfections and infestations | 1/38 | 3/33 | 1/60 |
| Cardiac arrestCardiac disorders | 1/38 | 2/33 | 1/60 |
| SepsisInfections and infestations | 1/38 | 2/33 | 1/60 |
| HypervolaemiaMetabolism and nutrition disorders | 2/38 | 0/33 | 1/60 |
| AnaemiaBlood and lymphatic system disorders | 0/38 | 1/33 | 2/60 |
| PneumoniaInfections and infestations | 1/38 | 1/33 | 2/60 |
| OsteomyelitisInfections and infestations | 0/38 | 1/33 | 2/60 |
| Deep vein thrombosisVascular disorders | 0/38 | 1/33 | 0/60 |
| Extremity necrosisVascular disorders | 0/38 | 1/33 | 0/60 |
| Event | SNF472 - Safety Analysis Population (Part 1) | Placebo - Safety Analysis Population (Part 1) | SNF472 Open Label - Safety Analysis Population (Part 2) |
|---|---|---|---|
| CalciphylaxisMetabolism and nutrition disorders | 8/38 | 8/33 | 4/60 |
| VomitingGastrointestinal disorders | 5/38 | 1/33 | 2/60 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/38 | 0/33 | 1/60 |
| NauseaGastrointestinal disorders | 2/38 | 4/33 | 3/60 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 4/38 | 2/33 | 5/60 |
| HeadacheNervous system disorders | 3/38 | 3/33 | 0/60 |
| FallInjury, poisoning and procedural complications | 3/38 | 1/33 | 5/60 |
| DiarrhoeaGastrointestinal disorders | 2/38 | 1/33 | 5/60 |
| HyperkalaemiaMetabolism and nutrition disorders | 1/38 | 1/33 | 4/60 |
| COVID-19Infections and infestations | 1/38 | 2/33 | 1/60 |
Modified Intent-to-treat Population (mITT): The modified mITT population was defined as all enrolled subjects who were randomized, received at least one dose of study drug, and had at least one post-randomization efficacy evaluation. The mITT population was the primary analysis population for efficacy endpoints.
| Age, Categorical(Participants) | SNF472 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 27 | 54 |
| >=65 years | 10 | 7 | 17 |
| Age, Continuous(years) | SNF472 | Placebo | Total |
|---|---|---|---|
| Mean | 57.7 ± 12.14 | 57.2 ± 11.30 | 57.5 ± 11.66 |
| Sex: Female, Male(Participants) | SNF472 | Placebo | Total |
|---|---|---|---|
| Female | 23 | 21 | 44 |
| Male | 14 | 13 | 27 |
| Ethnicity (NIH/OMB)(Participants) | SNF472 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 3 | 9 |
| Not Hispanic or Latino | 31 | 31 | 62 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SNF472 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 14 | 12 | 26 |
| White | 20 | 18 | 38 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | SNF472 | Placebo | Total |
|---|---|---|---|
| Europe | 5 | 2 | 7 |
| North America | 32 | 32 | 64 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2020 to primary completion in Oct 2022, 32 months.
Results were first posted in Feb 2024, 1 year 3 months after primary completion.
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Studies of the drug tested here: SNF472
Sanifit Therapeutics S. A.