CalciphylaxisPhase 3NCT02527213
Double-blind Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy
A Phase 3 study testing Sodium thiosulfate in people with Calciphylaxis and Calcific Uremic Arteriolopathy, run by American Regent, Inc. at 3 sites in United States.
Trial summary
To evaluate the efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an initial 28-day treatment phase. 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?
- Sodium thiosulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jan 2015to 29 Aug 2016
- 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
- Males or females ≥18 years of age who are able to give informed consent.
- Calcific uremic arteriolopathy (CUA), either newly-diagnosed or pre-existing, currently on STS or not yet treated with STS and either not on pain medication or on a stable pain medication regimen. The diagnosis of calciphylaxis can be made when:
- The following clinical features are all present, or two (2) of the following clinical features and typical histopathological findings are present.
- Clinical features:
- A patient on chronic hemodialysis for chronic kidney disease or with a glomerular filtration rate (GFR) of less than 15/ml/min/1.73 m2
- More than 2 painful and non-treatable skin ulcers with concomitant painful purpura
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- Painful and non-treatable skin ulcers on the trunk, extremities, or penis with concomitant painful purpura
- Histopathological findings by skin biopsy when 3 clinical findings are not present:
- Necrosis and ulceration of the skin with calcification of the tunica media and internal elastic membrane of small to medium-sized arterioles of dermis and subcutaneous fat are essential for the diagnosis
- Concentric stenosis due to edematous intimal thickening is also seen in the small to medium-sized arterioles of dermis and subcutaneous fat
- End stage renal disease (ESRD) on chronic maintenance hemodialysis.
- Willingness to undergo washout of pre-existing STS treatment (if required by treatment allocation) and to continue in a double blind treatment period of 4 weeks, during which they might receive placebo.
- Ability to comply with all study requirements.
Who cannot join
- History of allergic or other adverse reaction to STS
- Current treatment with STS for indications other than CUA (e.g. cyanide poisoning)
- Currently on alternative treatment for CUA as listed below. Unless treatment has been discontinued for at least 1 month prior to the screening visit.
- Steroids
- Hyperbaric Oxygen
- Bisphosphonates
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- Pentoxifylline
- Tissue Plasminogen Activator
- Lucilia sericata larvae (maggot therapy)
- On Cinacalcet for treatment for CUA (i.e. cinacalcet was either started or dose increased after the appearance of lesions)
- Any co-existing disease or problem that makes participation in the study unadvisable for the patient or compromises integrity of the study
- Cirrhosis of the liver
- History of congestive heart failure (New York Heart Association class III or IV) with multiple hospital admissions (at least 3 admissions in 6 months)
- Persistent and uncontrolled metabolic acidosis
- Chronic kidney disease or renal transplant patients with diagnosis of calciphylaxis who are not on hemodialysis.
- Any other disease or condition which, in the judgment of the Investigator, would place a subject at undue risk by being enrolled in the trial, or cause inability to comply with the trial
Trial locations and contacts
3 sites in 1 country.
United States3 sites
A.A. Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
Nephrology Association of Northern Indiana
Fort Wayne, Indiana, 46804
Nephrology Consultants
Huntsville, Alabama, 35805
About this study
Official title: Randomized Double Blind Placebo Controlled Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy Followed by a Single Armed Extension Phase to Prospectively Observe Lesion Progression
To evaluate the efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an initial 28-day treatment phase.
Read the detailed description
Efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an initial 28-day treatment phase.
- Conditions
- Calciphylaxis, Calcific Uremic Arteriolopathy
- Being tested
- Sodium thiosulfate, Placebo
- Medical subject headings
- Calciphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium thiosulfateDrug
Additional treatment(s) due to lesion progression When intervention occurs, the date of the intervening event should be recorded in the source documents and the (CRF). The subject should continue in the study as scheduled.
PlaceboDrug
Additional treatment(s) due to lesion progression When intervention occurs, the date of the intervening event should be recorded in the source documents and the (CRF). The subject should continue in the study as scheduled.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Thiosulfate | Experimental | Sodium Thiosulfate at 25g in 100 ml normal sterile saline (NSS) Receives: Drug: Sodium thiosulfate |
| Placebo | Placebo comparator | similarly-formulated placebo in 100 ml NSS Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Analgesic Requirement
The length of time in days, from first treatment with blinded study drug; to when subject requires rescue analgesic
Measured: up to 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start30 Jan 2015 (estimated)
- Primary completion29 Aug 2016 (estimated)
- Study completion29 Aug 2016 (estimated)
Why it stopped: Company decision -terminated on 30 October 2015
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Mundy, MD, PhD, Study director, American Regent, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527213
- Sponsor's protocol ID
- 1STS12001
- Status last verified
- May 2025
- First submitted
- 17 Aug 2015
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo Controlled Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy Followed by a Single Armed Extension Phase to Prospectively Observe Lesion Progression
- ClinicalTrials.gov ID
- NCT02527213
- Acronym / sponsor ID
- 1STS12001
- Conditions
- Calciphylaxis, Calcific Uremic Arteriolopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision -terminated on 30 October 2015
- Enrolment
- 0 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2015 (estimated)
- Primary completion
- 29 Aug 2016 (estimated)
- Study completion
- 29 Aug 2016 (estimated)
- First posted
- 18 Aug 2015 (estimated)
- 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.
To evaluate the efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an initial 28-day treatment phase.
Detailed description
Efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an initial 28-day treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Thiosulfate | Experimental | Drug: Sodium thiosulfateSodium Thiosulfate at 25g in 100 ml normal sterile saline (NSS) |
| Placebo | Placebo comparator | Drug: Placebosimilarly-formulated placebo in 100 ml NSS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males or females ≥18 years of age who are able to give informed consent.
- Calcific uremic arteriolopathy (CUA), either newly-diagnosed or pre-existing, currently on STS or not yet treated with STS and either not on pain medication or on a stable pain medication regimen. The diagnosis of calciphylaxis can be made when:
- A patient on chronic hemodialysis for chronic kidney disease or with a glomerular filtration rate (GFR) of less than 15/ml/min/1.73 m2
- More than 2 painful and non-treatable skin ulcers with concomitant painful purpura
- Painful and non-treatable skin ulcers on the trunk, extremities, or penis with concomitant painful purpura
Key exclusion criteria (16 listed)
- History of allergic or other adverse reaction to STS
- Current treatment with STS for indications other than CUA (e.g. cyanide poisoning)
- Currently on alternative treatment for CUA as listed below. Unless treatment has been discontinued for at least 1 month prior to the screening visit.
- Any co-existing disease or problem that makes participation in the study unadvisable for the patient or compromises integrity of the study
- Chronic kidney disease or renal transplant patients with diagnosis of calciphylaxis who are not on hemodialysis.
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 thiosulfateAdditional treatment(s) due to lesion progression When intervention occurs, the date of the intervening event should be recorded in the source documents and the (CRF). The subject should continue in the study as scheduled. | Drug | Sodium Thiosulfate |
| PlaceboAdditional treatment(s) due to lesion progression When intervention occurs, the date of the intervening event should be recorded in the source documents and the (CRF). The subject should continue in the study as scheduled. | Drug | Placebo |
Primary outcome
Reduction in Analgesic Requirement
Time frame: up to 28 Days
The length of time in days, from first treatment with blinded study drug; to when subject requires rescue analgesic
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- 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.
Linda Mundy, MD, PhD study director
American Regent, Inc.
3 sites in 1 country: 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 and Calcific Uremic Arteriolopathy, run by American Regent, Inc. at 3 sites in United States.
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 13 inclusion and 16 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: withdrawn, as of the sponsor's last update on 7 May 2025. 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. 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 withdrawn before enrolling participants, so there are no results.
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?
Reduction in Analgesic Requirement (time frame: up to 28 Days). 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 7 May 2025.