CalciphylaxisPhase 3CALISTANCT03150420
A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients
A Phase 3 study testing Sodium Thiosulfate in people with Calciphylaxis, run by Hope Pharmaceuticals at 21 sites in 3 countries.
Trial summary
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calciphylaxis
- What is being tested?
- Sodium Thiosulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 24 May 2017to 15 Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Informed of the investigational nature of the study and sign written informed consent
- Willing and able to adhere to all study-related procedures, including adherence to study medication regimen
- Male or female ≥18 years old
- End-stage renal disease on chronic hemodialysis
- Calciphylaxis with active skin lesion(s) of any morphological appearance (including but not limited to livedo, induration, ulceration, etc.) and tissue histology review consistent with calciphylaxis diagnosis. Histological features consistent with calciphylaxis will include soft tissue calcification, microthrombosis, and/or fibrointimal hyperplasia of dermal arterioles
- Acute pain associated with calciphylaxis lesions pain intensity score of ≥ 5 at initial screening on the modified BPI/SF scale
- Women of childbearing potential must have a pregnancy test (urine or serum [if anuric]) at screening and not be pregnant and willing to use an acceptable method of contraception for the entire duration of the study (3 weeks)
Who cannot join
- Peritoneal dialysis patients
- Current congestive heart failure exacerbation
- Baseline abnormalities related to QT prolongation (corrected QT interval > 470 ms), hypocalcemia (serum albumin-corrected calcium < 8 mg/dL ), metabolic acidosis (serum bicarbonate < 18 mmol/L, hypotension (resting systolic blood pressure while seated < 80), or interdialytic weight gain ≥ 4.0 kg
- History of ventricular arrhythmias including ventricular fibrillation or ventricular tachycardia associated with shortness of breath, dizziness, hypotension, or syncope
- Any prior (within the past 30 days) or current intravenous Sodium Thiosulfate Injection treatment
- Other investigational agent (drug, biologic, or device) study within the past 30 days and/or for the duration of the trial
Show all 13Show fewer
- Pregnant or lactating women
- History of allergy to sulfites, thiosulfate, or any component in Sodium Thiosulfate Injection (sulfa allergy is not an exclusion criterion)
- Significant other acute or chronic concomitant diseases (including but not limited to hepatic, cardiovascular, pulmonary, or oncologic disease, sepsis, pulmonary edema, pulmonary embolism) that would be inconsistent with survival for at least 3 months
- Other serious concurrent or recent medical or psychiatric condition which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study
- Ongoing application of dialysate admixed with iron salt e.g. ferric pyrophosphate during the entire trial period (patients who are on dialysate admixed with iron salt at screening are eligible if dialysate admixed with iron salt can be substituted with non-iron based dialysate and patients can be maintained on non-iron based dialysate therapy for the entire duration of trial period)
- Recent (within 1 week) history of surgical parathyroidectomy or scheduled for surgical parathyroidectomy during the course of the study
- History of opioid addiction
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States12 sites
Veterans Administration Medical Center
Albany, New York, 12208
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern University Hospital
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Sanford Health
Fargo, North Dakota, 58122
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Mayo Clinic
Jacksonville, Florida, 32224
Loyola University Medical Center
Maywood, Illinois, 60153
The Icahn School of Medicine at Mount Sinai Hospital
New York, New York, 10029
Rhode Island Hospital
Providence, Rhode Island, 02914
Veterans Administration Medical Center
Salem, Virginia, 24153
Canada5 sites
University of Calgary Foothills Medical Center
Calgary, Alberta, T2W 1S7
University of Alberta Hospital
Edmonton, Alberta, T6G 1Z1
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R2V 3M3
United Kingdom4 sites
Hammersmith Hospital
London, W12 0HS
Churchill Hospital
Oxford, OX3 7LE
Salford Royal Hospital NHS Foundation Trust
Salford, Manchester, M6 8HD
Lister Hospital
Stevenage, SG1 4AB
About this study
Official title: A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients.
Read the detailed description
This Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients. Acute calciphylaxis- associated pain intensity will be the primary outcome measure.
- Conditions
- Calciphylaxis
- Being tested
- Sodium Thiosulfate, Placebo-Normal Saline
- Keywords
- calciphylaxis, calcific uremic arteriolopathy, calcinosis, calcium metabolism disorders, metabolic diseases, sodium thiosulfate
- Medical subject headings
- Calciphylaxis, 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.
Sodium ThiosulfateDrug
Also called Intravenous Sodium Thiosulfate Injection
Intravenous Sodium Thiosulfate Injection (25 grams sodium thiosulfate) to be administered each hemodialysis session (3 times weekly) for 3 weeks
Placebo-Normal SalineDrug
Also called 0.9% sodium chloride solution
Placebo: to be administered each hemodialysis session (3 times weekly) for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sodium Thiosulfate | Experimental | Sodium Thiosulfate Injection (25 grams sodium thiosulfate) Receives: Drug: Sodium Thiosulfate |
| Placebo-Normal Saline | Placebo comparator | 0.9% sodium chloride injection, USP (normal saline) Receives: Drug: Placebo-Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with 30% improvement in pain severity
To compare the effects of treatment with intravenous Sodium Thiosulfate Injection vs. placebo for the proportion of patients (responders) who achieve a ≥ 30% reduction based upon pain intensity score (modified BPI/SF).
Measured: randomization to 3 weeks
Secondary outcomes (4)
Secondary Endpoint-a: Number of patients with stabilization or improvement in calciphylaxis skin lesions.
Proportion of patients who achieve improvement or stabilization (i.e., not worsening) of skin lesions.
Measured: randomization to 3 weeks
Secondary Endpoint-b: Occurence of surgical debridement of skin lesions and/or amputation.
Occurence of surgical debridement of skin lesions and/or amputation.
Measured: during week 3
Secondary Endpoint-c: Occurrence of surgical debridement of skin lesions and/or amputation.
Occurrence of surgical debridement of skin lesions and/or amputation.
Measured: randomization to 3 weeks
Secondary Endpoint-d: Time to achieve ≥ 30% improvement in pain severity
Time in days when a patient achieves a ≥ 30% improvement based upon pain intensity score (modified BPI/SF).
Measured: randomization to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start24 May 2017
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Why it stopped: Inability to accrue subjects that met the exclusion criterion "Any prior (within the past 30 days) or current Sodium Thiosulfate treatment".
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hope Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Sherman, MD, Study director, Hope Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150420
- Sponsor's protocol ID
- ST-001
- Acronym
- CALISTA
- Status last verified
- May 2020
- First submitted
- 29 Mar 2017
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT03150420
- Acronym / sponsor ID
- CALISTA / ST-001
- Conditions
- Calciphylaxis
- Keywords
- calciphylaxis, calcific uremic arteriolopathy, calcinosis, calcium metabolism disorders, metabolic diseases, sodium thiosulfate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to accrue subjects that met the exclusion criterion "Any prior (within the past 30 days) or current Sodium Thiosulfate treatment".
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hope PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 May 2017 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients.
Detailed description
This Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients. Acute calciphylaxis- associated pain intensity will be the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Thiosulfate | Experimental | Drug: Sodium ThiosulfateSodium Thiosulfate Injection (25 grams sodium thiosulfate) |
| Placebo-Normal Saline | Placebo comparator | Drug: Placebo-Normal Saline0.9% sodium chloride injection, USP (normal saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed of the investigational nature of the study and sign written informed consent
- Willing and able to adhere to all study-related procedures, including adherence to study medication regimen
- Male or female ≥18 years old
- End-stage renal disease on chronic hemodialysis
- Calciphylaxis with active skin lesion(s) of any morphological appearance (including but not limited to livedo, induration, ulceration, etc.) and tissue histology review consistent with calciphylaxis diagnosis. Histological features consistent with calciphylaxis will include soft tissue calcification, microthrombosis, and/or fibrointimal hyperplasia of dermal arterioles
Key exclusion criteria (13 listed)
- Peritoneal dialysis patients
- Current congestive heart failure exacerbation
- Baseline abnormalities related to QT prolongation (corrected QT interval > 470 ms), hypocalcemia (serum albumin-corrected calcium < 8 mg/dL ), metabolic acidosis (serum bicarbonate < 18 mmol/L, hypotension (resting systolic blood pressure while seated < 80), or interdialytic weight gain ≥ 4.0 kg
- History of ventricular arrhythmias including ventricular fibrillation or ventricular tachycardia associated with shortness of breath, dizziness, hypotension, or syncope
- Any prior (within the past 30 days) or current intravenous Sodium Thiosulfate Injection treatment
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 |
|---|---|---|
| Sodium ThiosulfateAlso: Intravenous Sodium Thiosulfate InjectionIntravenous Sodium Thiosulfate Injection (25 grams sodium thiosulfate) to be administered each hemodialysis session (3 times weekly) for 3 weeks | Drug | Sodium Thiosulfate |
| Placebo-Normal SalineAlso: 0.9% sodium chloride solutionPlacebo: to be administered each hemodialysis session (3 times weekly) for 3 weeks | Drug | Placebo-Normal Saline |
Primary outcome
Number of patients with 30% improvement in pain severity
Time frame: randomization to 3 weeks
To compare the effects of treatment with intravenous Sodium Thiosulfate Injection vs. placebo for the proportion of patients (responders) who achieve a ≥ 30% reduction based upon pain intensity score (modified BPI/SF).
4 secondary outcomes
Secondary Endpoint-a: Number of patients with stabilization or improvement in calciphylaxis skin lesions.
Time frame: randomization to 3 weeks
Secondary Endpoint-b: Occurence of surgical debridement of skin lesions and/or amputation.
Time frame: during week 3
Secondary Endpoint-c: Occurrence of surgical debridement of skin lesions and/or amputation.
Time frame: randomization to 3 weeks
Secondary Endpoint-d: Time to achieve ≥ 30% improvement in pain severity
Time frame: randomization to 3 weeks
Results and safety
The study was stopped early (reason given: Inability to accrue subjects that met the exclusion criterion "Any prior (within the past 30 days) or current Sodium Thiosulfate treatment".). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Craig Sherman, MD study director
Hope Pharmaceuticals
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Thiosulfate in people with Calciphylaxis, run by Hope Pharmaceuticals at 21 sites in 3 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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada, 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. 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?
The study was stopped early (reason given: Inability to accrue subjects that met the exclusion criterion "Any prior (within the past 30 days) or current Sodium Thiosulfate treatment".). Results are not available in the source record.
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?
Number of patients with 30% improvement in pain severity (time frame: randomization to 3 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 19 May 2020.