Randomized Double Blind Placebo Controlled Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopath

Calciphylaxis Clinical Trial

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 in the Presence of Sodium Thiosulfate Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02527213
• Other study ID #: 1STS12001
• Status: Terminated
• Phase: Phase 3
• First received: August 17, 2015
• Last updated: January 19, 2017
• Start date: January 30, 2015
• Est. completion date: August 29, 2016

Study information

• Verified date: January 2017
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 29, 2016
• Est. primary completion date: August 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males or females =18 years of age who are able to give informed consent.

2. 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:

1. A patient on chronic hemodialysis for chronic kidney disease or with a GFR of less than 15/ml/min/1.73 m2

2. More than 2 painful and non-treatable skin ulcers with concomitant painful purpura

3. 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:

1. 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

2. Concentric stenosis due to edematous intimal thickening is also seen in the small to medium-sized arterioles of dermis and subcutaneous fat

3. End stage renal disease (ESRD) on chronic maintenance hemodialysis.

4. 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.

5. Ability to comply with all study requirements.

Exclusion Criteria:

1. History of allergic or other adverse reaction to STS

2. Current treatment with STS for indications other than CUA (e.g. cyanide poisoning)

3. Currently on alternative treatment for CUA as listed below. Unless treatment has been discontinued for at least 1 month prior to the screening visit.

1. Steroids

2. Hyperbaric Oxygen

3. Bisphosphonates

4. Pentoxifylline

5. Tissue Plasminogen Activator

6. Luciliar sericata larvae (maggot therapy)

7. On Cinacalcet for treatment for CUA (i.e. cinacalcet was either started or dose increased after the appearance of lesions)

4. Any co-existing disease or problem that makes participation in the study unadvisable for the patient or compromises integrity of the study

1. Cirrhosis of the liver

2. History of congestive heart failure (New York Heart Association class III or IV) with multiple hospital admissions (at least 3 admissions in 6 months)

3. Persistent and uncontrolled metabolic acidosis

5. Chronic kidney disease or renal transplant patients with diagnosis of calciphylaxis who are not on hemodialysis.

6. 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

Related Conditions & MeSH terms

• Calcific Uremic Arteriolopathy
• Calciphylaxis

Intervention

Drug:
• Sodium thiosulfate
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	A.A. Northeast Clinical Research Center	Bethlehem	Pennsylvania
United States	Nephrology Association of Northern Indiana	Fort Wayne	Indiana
United States	Nephrology Consultants	Huntsville	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Analgesic Requirement	The length of time in days, from first treatment with blinded study drug; to when subject requires rescue analgesic	up to 28 Days