Double-blind Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy

NCT ID: NCT02527213

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-30
• Study Completion Date: 2016-08-29

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sodium Thiosulfate

Sodium Thiosulfate at 25g in 100 ml normal sterile saline (NSS)

Group Type: EXPERIMENTAL

Sodium thiosulfate

Intervention Type: DRUG

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

similarly-formulated placebo in 100 ml NSS

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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 glomerular filtration rate (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. Lucilia 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Mundy, MD, PhD

Role: STUDY_DIRECTOR

American Regent, Inc.

Locations

Nephrology Consultants

Huntsville, Alabama, United States

Nephrology Association of Northern Indiana

Fort Wayne, Indiana, United States

A.A. Northeast Clinical Research Center

Bethlehem, Pennsylvania, United States

Countries

United States

Other Identifiers

1STS12001

Identifier Type: -

Identifier Source: org_study_id