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Sodium Thiosulfate for Calcinosis (STSINJ Trial)

Phase 2
Waitlist Available
Led By Robyn T Domsis, MD
Research Sponsored by Robyn T. Domsic, MD, MPH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be over 18 years of age
Participants must have radiographic evidence (x-ray or ultrasound) of calcinosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of injecting STS directly into calcinosis lesions in patients with certain autoimmune diseases. The injection process will be guided by ultrasound, and the effects on lesion

Who is the study for?
This trial is for individuals with conditions like systemic sclerosis, lupus, dermatomyositis, and other connective tissue diseases who have calcinosis. Participants should have symptoms or lesions that can be measured. Specific eligibility criteria are not provided but typically include age limits and health status requirements.
What is being tested?
The study tests the safety and effectiveness of Sodium Thiosulfate (STS) injections directly into calcified lesions in patients with certain connective tissue disorders. The size of the lesion will be monitored by ultrasound, and patient feedback on symptom relief will also be recorded.
What are the potential side effects?
While specific side effects are not listed here, intralesional STS injections may cause local reactions such as pain or swelling at the injection site, potential skin changes, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.
Select...
My scans show calcium deposits in my body.
Select...
I have been diagnosed with systemic sclerosis, mixed connective tissue disease, or inflammatory myopathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary endpoint: Change in size of calcinosis lesion from baseline to 12 weeks
Secondary study objectives
Change in Pain Intensity
Change in calcinosis patient-reported outcome
Change in pain (interference)
+2 more

Side effects data

From 2023 Phase 2 & 3 trial • 15 Patients • NCT03267277
100%
Flow cytometry
100%
Systolic hypertension
100%
Venous oxygen saturation decreased
100%
Hypertension
100%
Venous oxygen saturation increased
93%
Hyperglycemia
93%
Diastolic hypotension
93%
Immature granulocyte percentage increased
93%
Creatinine urine decreased
93%
Red blood cell count decreased
93%
Urine sodium increased
93%
Urine protein, quantitative increased
93%
Hypokalemia
93%
Hyponatremia
93%
Blood lactate dehydrogenase increased
93%
Anemia
93%
Blood chloride increased
86%
Urine protein/creatinine ratio increased
86%
Urine magnesium decreased
86%
Red cell distribution width increased
86%
White blood cells urine increased
86%
Coagulation factor VIII level increased
86%
Urine analysis abnormal
79%
Blood bicarbonate decreased
79%
Mean cell hemoglobin concentration decreased
79%
PO2 increased
79%
PCO2 decreased
79%
Carbon dioxide decreased
79%
Blood bicarbonate increased
71%
Vitamin D decreased
71%
Venous blood pH decreased
71%
Urine ketone body present
71%
Creatinine renal clearance decreased
71%
Red blood cells urine increased
71%
Immature granulocyte count increased
71%
Urine phosphorus decreased
71%
Hypocalcemia
71%
Blood immunoglobulin G increased
71%
Blood albumin decreased
64%
Calcium ionized decreased
64%
Ionized Magnesium increased
64%
Creatinine urine increased
64%
Reticulocyte percentage increased
64%
Ionized Magnesium decreased
64%
Lymphocyte percentage increased
64%
Hypoglycemia
64%
C-reactive protein-high sensitivity increased
64%
Blood creatinine decreased
64%
Sinus tachycardia
57%
Red blood cell sedimentation rate increased
57%
Cystatin C increased
57%
Eosinophil count decreased
57%
Urine leukocyte esterase positive
57%
Reticulocyte hemoglobin equivalent
50%
Neutrophil percentage decreased
50%
Serum ferritin increased
50%
Absolute neutrophil count increased
50%
Glucose urine present
50%
Blood urea nitrogen decreased
50%
Urine magnesium increased
50%
Urine potassium decreased
50%
Erythroblast count increased
50%
Transferrin saturation decreased
50%
Nausea
50%
Blood phosphorus decreased
50%
Basophil percentage increased
43%
Antinuclear antibody increased
43%
Neutrophil percentage increased
43%
Von Willebrand's factor activity increased
43%
Hypomagnesemia
43%
Hypotension
43%
Hemoglobin urine present
43%
Fibroblast growth factor 23 increased
43%
Lymphocyte percentage decreased
43%
Monocyte percentage decreased
43%
Eosinophil percentage decreased
43%
Protein total increased
43%
Urine phosphorus increased
43%
White blood cell count increased
43%
Reticulocyte count increased
43%
Blood immunoglobulin E increased
43%
Alanine aminotransferase increased
43%
Urine oxalate decreased
43%
Mean platelet volume decreased
43%
Activated partial thromboplastin time shortened
43%
Blood creatine phosphokinase increased
43%
Basophil count increased
43%
Blood iron decreased
43%
Blood parathyroid hormone increased
43%
Blood phosphorus increased
36%
Brain natriuretic peptide increased
36%
Blood thyroid stimulating hormone increased
36%
Aspartate aminotransferase increased
36%
Diastolic hypertension
36%
Urine calcium decreased
36%
Absolute lymphocyte count increased
36%
Protein urine present
36%
Platelet count decreased
36%
Headache
36%
Citric acid urine decreased
36%
Blood immunoglobulin A increased
36%
Anion gap increased
36%
Anion gap decreased
36%
Blood erythropoietin increased
36%
Blood insulin increased
29%
Myelocyte percentage increased
29%
Eosinophil percentage increased
29%
Absolute monocyte count increased
29%
Urine uric acid increased
29%
Pain in extremity
29%
Absolute monocyte count decreased
29%
White blood cell count decreased
29%
Sinus bradycardia
29%
Absolute neutrophil count decreased
29%
Von Willebrand's factor antigen increased
29%
Calcium ionized increased
29%
Urinary casts present
29%
Blood alkaline phosphatase decreased
29%
Blood uric acid increased
29%
Protein total decreased
29%
Blood chloride decreased
29%
Aldolase increased
29%
Blood creatine phosphokinase MB increased
29%
Abnormal clotting factor
21%
Monocyte percentage increased
21%
Creatinine renal clearance increased
21%
Hepatitis B core antibody positive
21%
Hepatitis B surface antigen positive
21%
Glycosylated hemoglobin increased
21%
Human T-cell lymphotropic virus infection
21%
Blood immunoglobulin M decreased
21%
Urine calcium increased
21%
PO2 decreased
21%
Hypernatremia
21%
Activated partial thromboplastin time prolonged
21%
Basophil count decreased
21%
Antinuclear antibody positive
21%
Corona virus infection
21%
Basophil percentage decreased
21%
Blood triglycerides increased
14%
Specific gravity urine increased
14%
Blood thyroid stimulating hormone decreased
14%
Thyroxine free decreased
14%
Platelet count increased
14%
Urobilinogen urine
14%
Red blood cell morphology abnormal
14%
Nitrite urine present
14%
Metamyelocyte percentage increased
14%
Urine calcium oxalate
14%
Transferrin decreased
14%
Hypercalcemia
14%
Prothrombin time prolonged
14%
Insulin C-peptide increased
14%
Urine albumin/creatinine ratio increased
14%
Autoantibody positive
14%
Mean cell hemoglobin decreased
14%
Urine sodium decreased
14%
Absolute lymphocyte count decreased
14%
Urine uric acid decreased
14%
Vitamin D increased
14%
Vitamin B12 increased
14%
Anisocytosis
14%
Blood magnesium increased
14%
Catheter site infection
14%
Dental caries
14%
Hyperthermia
14%
Blood cholesterol increased
14%
Blood folate increased
7%
Blister
7%
Migraine
7%
Blood calcium decreased
7%
Blood glucose increased
7%
pH urine increased
7%
Urea renal clearance decreased
7%
Transferrin increased
7%
Hyperkalemia
7%
Laboratory test
7%
Platelet morphology abnormal
7%
Blood bilirubin increased
7%
Transferrin saturation increased
7%
Urine oxalate increased
7%
Haptoglobin decreased
7%
Nasal congestion
7%
Serum ferritin decreased
7%
T-lymphocyte count increased
7%
Thyroxine decreased
7%
Haptoglobin increased
7%
Low density lipoprotein abnormal
7%
Promyelocyte count increased
7%
Red blood cell poikilocytes present
7%
Reticulocyte count decreased
7%
PCO2 increased
7%
Blood bilirubin decreased
7%
Blood creatine phosphokinase decreased
7%
Red blood cell sedimentation rate
7%
Electrophoresis protein abnormal
7%
Fibrin D dimer increased
7%
Mean cell volume increased
7%
Procedural dizziness
7%
Red blood cell microcytes present
7%
Pruritus
7%
Beta 2 microglobulin urine increased
7%
Bilirubin conjugated
7%
Cystatin C abnormal
7%
Eosinophil count increased
7%
Mean cell volume decreased
7%
Prothrombin time shortened
7%
Blood creatinine increased
7%
Urine potassium increased
7%
Urine amino acid level abnormal
7%
Blood urea nitrogen increased
7%
Hemoglobin decreased
7%
Mean cell hemoglobin increased
7%
Neutrophil count decreased
7%
Hyperuricemia
7%
Lipids abnormal
7%
Nephrolithiasis
7%
Venous blood pH increased
7%
Citric acid urine increased
7%
Anxiety
7%
Carbon dioxide increased
7%
Drug level above therapeutic
7%
Albumin urine present
7%
Blood iron increased
7%
Blood parathyroid hormone
7%
Lymphocyte count decreased
7%
Bilirubin urine present
7%
Device related infection
7%
Foreign body
7%
Alanine aminotransferase
7%
Vomiting
7%
Blood homocysteine increased
7%
Blood immunoglobulin D increased
7%
Epstein-Barr virus infection
7%
Hepatitis viral
7%
Anion gap
7%
Aspartate aminotransferase
7%
Wound infection staphylococcal
7%
Aspartate aminotransferase decreased
7%
Blood parathyroid hormone decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sodium thiosulfate (STS)Experimental Treatment1 Intervention
Open label, single-arm, receiving 1-5ml of STS (250mg/ml) sodium thiosulfate (STS) injections to calcinosis lesions.

Find a Location

Who is running the clinical trial?

Robyn T. Domsic, MD, MPHLead Sponsor
2 Previous Clinical Trials
184 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,492 Total Patients Enrolled
Robyn T Domsis, MDPrincipal InvestigatorUniversity of Pittsburgh
~13 spots leftby May 2025
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