CalciphylaxisPhase 2NCT02790073
Phase 2 Study With SNF472 in Calciphylaxis Patients
A Phase 2 study testing SNF472 in people with Calciphylaxis and Calcific Uremic Arteriolopathy, run by Sanifit Therapeutics S. A. at 3 sites in 2 countries.
Trial summary
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). 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?
- SNF472
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2016to 15 Nov 2017
- Phase
- Phase 2
- 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
- Patients with either newly diagnosed CUA OR recurrent CUA that has been dormant with no skin lesion involvement for at least 90 days from study start (new or recurrent diagnosis must be made within 5 weeks of study start)
- Patients who signed the written informed consent to participate in this clinical trial (prior to any clinical trial-related procedures being performed), after reading the Patient Information Sheet and Informed Consent Form (ICF), and who had the opportunity to discuss the clinical trial with the Investigator or designee
- Males or females aged ≥18
- Patients on maintenance haemodialysis (HD)
- Patients with at least a minimum level of pain on Visual Analog Scale (VAS) scale or on pain-killers stronger than non-steroidal anti-inflammatory drugs (NSAIDs)
- Females of child-bearing potential should use a highly effective contraceptive measure throughout the study and have a negative serum pregnancy test at entry. Male patients having sexual relationship in which pregnancy can occur should take adequate contraceptive precautions (wear a condom)
Who cannot join
- Body weight above 150 kg
- BMI >35 and central(abdominal) ulcers
- History of bisphosphonate treatment within 12 months before entering into the study
- Severely ill patients without reasonable expectation of survival for > 6 months according to the treating physician
- Patients with scheduled parathyroidectomy during the run-in or study period
- Female patients who are either intending to get pregnant or are undergoing treatment to get pregnant, as well as breast-feeding females
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- Participation in another clinical trial with an experimental drug within 90 days prior the inclusion
- Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the patient to comply with the Clinical Trial Protocol requirements
- Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Davita Clinical Research
Minneapolis, Minnesota, 55404
Fresenius Medical Services
Waltham, Massachusetts, 02451
About this study
Official title: Phase 2 Open Label Single Arm Repeat Dose Study to Assess the Effect of SNF472 on Wound Healing in Uraemic Calciphylaxis Patients
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).
- Conditions
- Calciphylaxis, Calcific Uremic Arteriolopathy
- Being tested
- SNF472
- Keywords
- Calciphylaxis, Calcific Uremic Arteriolopathy, Dialysis, End Stage Renal Disease, Rare disease (ORPHA280062), Calcification, Calcium Metabolism Disorders, Calcinosis, Metabolic Diseases
- Medical subject headings
- Calciphylaxis, Kidney Failure, Chronic, Rare Diseases, Calcinosis, Calcium Metabolism Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNF472Drug
SNF472 for calciphylaxis
| Study group | Role | What they receive |
|---|---|---|
| SNF472 | Other | SNF472 for calciphylaxis Receives: Drug: SNF472 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (2)
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).
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanifit Therapeutics S. A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Brandenburg, Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790073
- Sponsor's protocol ID
- SNFCT2015_04
- Status last verified
- Aug 2019
- First submitted
- 25 May 2016
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Open Label Single Arm Repeat Dose Study to Assess the Effect of SNF472 on Wound Healing in Uraemic Calciphylaxis Patients
- ClinicalTrials.gov ID
- NCT02790073
- Acronym / sponsor ID
- SNFCT2015_04
- Conditions
- Calciphylaxis, Calcific Uremic Arteriolopathy
- Keywords
- Calciphylaxis, Calcific Uremic Arteriolopathy, Dialysis, End Stage Renal Disease, Rare disease (ORPHA280062), Calcification, Calcium Metabolism Disorders, Calcinosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sanifit Therapeutics S. A.University, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNF472 | Other | Drug: SNF472SNF472 for calciphylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with either newly diagnosed CUA OR recurrent CUA that has been dormant with no skin lesion involvement for at least 90 days from study start (new or recurrent diagnosis must be made within 5 weeks of study start)
- Patients who signed the written informed consent to participate in this clinical trial (prior to any clinical trial-related procedures being performed), after reading the Patient Information Sheet and Informed Consent Form (ICF), and who had the opportunity to discuss the clinical trial with the Investigator or designee
- Males or females aged ≥18
- Patients on maintenance haemodialysis (HD)
- Patients with at least a minimum level of pain on Visual Analog Scale (VAS) scale or on pain-killers stronger than non-steroidal anti-inflammatory drugs (NSAIDs)
Key exclusion criteria (9 listed)
- Body weight above 150 kg
- BMI >35 and central(abdominal) ulcers
- History of bisphosphonate treatment within 12 months before entering into the study
- Severely ill patients without reasonable expectation of survival for > 6 months according to the treating physician
- Patients with scheduled parathyroidectomy during the run-in or study period
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 |
|---|---|---|
| SNF472SNF472 for calciphylaxis | Drug | SNF472 |
Primary outcome
Wound Healing
Time frame: 12 weeks
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).
2 secondary outcomes
Wound Pain
Time frame: 12 weeks
Wound-QoL Global Score
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- USA FDA resourcesLink provided by the sponsor.
- Drug Information available for: SNF472Link provided by the sponsor.
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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.
Vincent Brandenburg principal investigator
RWTH Aachen University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNF472 in people with Calciphylaxis and Calcific Uremic Arteriolopathy, run by Sanifit Therapeutics S. A. at 3 sites in 2 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 9 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, United Kingdom. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Aug 2019). 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?
Wound Healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2019.