CalciphylaxisPhase 3CalciphyxNCT04195906
Phase 3 Study of SNF472 for Calciphylaxis
A Phase 3 study testing Experimental: SNF472 and Experimatenl SNF472 (Open-label) in people with Calciphylaxis and Calcific Uremic Arteriolopathy, run by Sanifit Therapeutics S. A. at 58 sites in 6 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calciphylaxis, Calcific Uremic Arteriolopathy
- What is being tested?
- Experimental: SNF472 and Experimatenl SNF472 (Open-label)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 58 sitesin 6 countries
- Study dates
- 12 Feb 2020to 24 Oct 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
58 sites in 6 countries.
58 sites in 6 countries
United States38 sites
DaVita Clinical Research
Asheville, North Carolina, 28801
Fresenius Kidney Care
Bethlehem, Pennsylvania, 18017
Boca Nephrology, PA
Boca Raton, Florida, 33431
Massachusetts General Hospital
Boston, Massachusetts, 02114
Fresenius Kidney Care
Brookhaven, Mississippi, 39601
DaVita Clinical Research
Chesapeake, Virginia, 23320
DaVita Clinical Research
Chester, Pennsylvania, 19013
Fresenius Kidney Care
Columbia, South Carolina, 29203
Hypertension Nephrology Consultants, Inc
Columbus, Ohio, 43215
Colorado Kidney Care
Denver, Colorado, 80230
Fresenius Kidney Care
Durham, North Carolina, 22704
California Institute of Renal Research
El Centro, California, 92243
California Institute of Renal Research
Escondido, California, 92027
Kidney Disease Medical Group
Glendale, California, 91204
DaVita Clinical Research
Hollywood, Florida, 33024
DaVita Clinical Research
Houston, Texas, 77004
DaVita Clinical Research
Kansas City, Missouri, 64111
Knoxville Kidney Center
Knoxville, Tennessee, 37923
DaVita Clinical Research
Las Vegas, Nevada, 89128
DaVita Clinical Research
Lynwood, California, 90260
DaVita Clinical Research
Minneapolis, Minnesota, 55404
DaVita Clinical Research
Norfolk, Virginia, 23502
AKDHC Medical Research Services
Phoenix, Arizona, 85035
Michigan Kidney Consultants
Pontiac, Michigan, 48341
Fresenius Kidney Care
Reno, Nevada, 89511
Apex Research of Riverside
Riverside, California, 92505
Fresenius Kidney Care
Roanoke, Virginia, 24014
DaVita Clinical Research
Roseville, Michigan, 48066
Clinical Advancement Center
San Antonio, Texas, 78212
Fresenius Kidney Care
San Diego, California, 92111
North America Research Institute
San Dimas, California, 91773
Novel Outcomes Research
Spring Hill, Florida, 34667
DaVita Clinical Research
Tampa, Florida, 33614
Fresenius Kidney Care
Tampa, Florida, 33614
DaVita Clinical Research
The Bronx, New York, 10461
Amicis Research Center
Vacaville, California, 95687
DaVita Clinical Research
Wauwatosa, Wisconsin, 53226
Piedmont Dialysis Center
Winston-Salem, North Carolina, 27101
United Kingdom6 sites
Queen Elizabeth Hospital
Birmingham, West Midlands
Royal Devon and Exeter Hospital (Wonford)
Exeter, Devon
Queen Elizabeth University Hospital Campus
Glasgow, Strathclyde
Leicester General Hospital
Leicester, Leicestershire, le5 4pw
Kings College Hospital
London, SE59RS
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD
Poland5 sites
Centrum Dializ Fresenius, Ośrodek Dializ nr 10 w Bydgoszczy 85-826
Bydgoszcz
Centrum Dializ Fresenius, Ośrodek Dializ nr 18 w Krakowie..
Krakow
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi Stacja Dializ,
Lodz
DaVita Sp. z o.o., Stacja Dializ w Miechowie
Miechów
Centrum Dializ Fresenius Ośrodek Dializ nr 32 w Radomiu 26-617 .
Radom
Belgium3 sites
Clinques Universitaries de Bruxelles Hopital
Brussels
UZ Leuven
Leuven
AZ Delta
Roeselare
Germany3 sites
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin
DaVita Deutschland AG
Düsseldorf
Nephrologischen Zentrum Villingen-Schwenningen
Villingen-Schwenningen, Baden-Wurttemberg
Spain3 sites
Fundacio Puigvert
Barcelona, 08025
University of Barcelona Hospital Clinic
Barcelona, 08036
Hospital Universitario Reina Sofia
Córdoba
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Background Care for the Treatment of Calciphylaxis
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).
Read the detailed description
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.. .
- Conditions
- Calciphylaxis, Calcific Uremic Arteriolopathy
- Being tested
- Experimental: SNF472, Placebo Comparator: Placebo, Experimatenl SNF472 (Open-label)
- Keywords
- Calciphylaxis, Calcific Uremic Arteriolopathy, Wound, ESRD
- Medical subject headings
- Calciphylaxis, Wounds and Injuries, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: SNF472Drug
Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks
Placebo Comparator: PlaceboDrug
Also called Saline
Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions fo 12 weeks
Experimatenl SNF472 (Open-label)Drug
Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| SNF472 (Double-Blind Period) | Experimental | Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. Receives: Drug: Experimental: SNF472 |
| Placebo (Double-Blind Period) | Placebo comparator | Matching placebo (saline) diluted in 100 mL physiological saline. Receives: Drug: Placebo Comparator: Placebo |
| SNF472 (Open-Label) | Experimental | Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. Receives: Drug: Experimatenl SNF472 (Open-label) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: from Baseline to Week 12
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: from Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start12 Feb 2020
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CalciphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanifit Therapeutics S. A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Gold, MD, Study director, Sanifit Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195906
- Sponsor's protocol ID
- SNFCT2017-06
- Acronym
- Calciphyx
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2019
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sinha S, Nigwekar SU, Brandenburg V, Gould LJ, Serena TE, Moe SM, Aronoff GR, Chatoth DK, Hymes JL, Carroll KJ, Alperovich G, Keller LH, Perello J, Gold A, Chertow GM. Hexasodium fytate for the treatment of calciphylaxis: a randomised, double-blind, phase 3, placebo-controlled trial with an open-label extension. EClinicalMedicine. 2024 Aug 16;75:102784. doi: 10.1016/j.eclinm.2024.102784. eCollection 2024 Sep.
PubMed 39252867Krishnasamy R, Jardine MJ; BEAT-Calci Trialists. Adaptive Designs for Clinical Trials in Nephrology. J Am Soc Nephrol. 2025 Jan 1;36(1):147-149. doi: 10.1681/ASN.0000000000000497. Epub 2024 Aug 26. No abstract available.
PubMed 39186385
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Background Care for the Treatment of Calciphylaxis
- ClinicalTrials.gov ID
- NCT04195906
- Acronym / sponsor ID
- Calciphyx / SNFCT2017-06
- Conditions
- Calciphylaxis, Calcific Uremic Arteriolopathy
- Keywords
- Calciphylaxis, Calcific Uremic Arteriolopathy, Wound, ESRD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Sanifit Therapeutics S. A.University, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SNF472 (Double-Blind Period) | Experimental | Drug: Experimental: SNF472Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. |
| Placebo (Double-Blind Period) | Placebo comparator | Drug: Placebo Comparator: PlaceboMatching placebo (saline) diluted in 100 mL physiological saline. |
| SNF472 (Open-Label) | Experimental | Drug: Experimatenl SNF472 (Open-label)Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: SNF472Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks | Drug | SNF472 (Double-Blind Period) |
| Placebo Comparator: PlaceboAlso: SalineAdministered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions fo 12 weeks | Drug | Placebo (Double-Blind Period) |
| 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 | Drug | SNF472 (Open-Label) |
Primary outcome
Absolute Change in the BWAT - CUA Score for the Primary Lesion
Time frame: from Baseline to Week 12
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
Absolute Change in Pain Visual Analog Score
Time frame: from Baseline to Week 12
The Pain Visual Analog Scale (VAS) score ranges from a minimum score of 0 (no pain) to 100 (worst possible pain).
4 secondary outcomes
Absolute Change in the Wound-Quality of Life Score
Time frame: from Baseline to Week 12
Absolute Change in the BWAT Total Score for the Primary Lesion
Time frame: from Baseline to Week 12
Qualitative Wound Image Evaluation for the Primary Lesion
Time frame: at Week 12
Rate of Change in Opioid Use as Measured in Morphine Milligram Equivalents (MME)
Time frame: from Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39252867Sinha S, Nigwekar SU, Brandenburg V, Gould LJ, Serena TE, Moe SM, Aronoff GR, Chatoth DK, Hymes JL, Carroll KJ, Alperovich G, Keller LH, Perello J, Gold A, Chertow GM. Hexasodium fytate for the treatment of calciphylaxis: a randomised, double-blind, phase 3, placebo-controlled trial with an open-label extension. EClinicalMedicine. 2024 Aug 16;75:102784. doi: 10.1016/j.eclinm.2024.102784. eCollection 2024 Sep.
- Derived from this study: PubMed 39186385Krishnasamy R, Jardine MJ; BEAT-Calci Trialists. Adaptive Designs for Clinical Trials in Nephrology. J Am Soc Nephrol. 2025 Jan 1;36(1):147-149. doi: 10.1681/ASN.0000000000000497. Epub 2024 Aug 26. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Gold, MD study director
Sanifit Therapeutics
58 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: SNF472 and Experimatenl SNF472 (Open-label) in people with Calciphylaxis and Calcific Uremic Arteriolopathy, run by Sanifit Therapeutics S. A. at 58 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, United Kingdom, Poland, Belgium, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in the BWAT - CUA Score for the Primary Lesion (time frame: from Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04195906, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.