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To evaluate the effect of SNF472 on top of standard of care on promoting wound healing and other parameters of therapeutic response in haemodialysis patients with calciphylaxis (calcific uraemic arteriolopathy, CUA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNF472 | Other | SNF472 for calciphylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNF472 | Drug | SNF472 for calciphylaxis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | Absolute change in Bates-Jensen Wound Assessment (BWAT) total score between baseline (Week 1) and Week 12 for the primary lesion (the largest one). The Bates-Jensen Wound Assessment (BWAT) is a standardized tool for quantitative assessment of wound healing that includes the 13 items listed below.
Each item was rated on a scale of 1 (best) to 5 (worst). The Bates-Jensen Wound Assessment (BWAT) total score is the sum of the individual items with a possible range of 13 (best) to 65 (worst). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Pain | Absolute change from baseline (Week 1) and Week 12 in the Pain Visual Analogue Scale (VAS) Score. The Pain Visual Analogue Scale (VAS) Score is a horizontal line, 100 mm in length, anchored by word descriptors at each end. The subject marked the point on the line that represented his/her perception of his/her current pain status. The Pain Visual Analogue Scale (VAS) Score was determined by measuring in millimeters from the left hand end of the line (no pain) to the point that the subject marked. The Pain Visual Analogue Scale (VAS) Score range 0 (best) to 100 (Worst). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Brandenburg | RWTH Aachen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fresenius Medical Services | Waltham | Massachusetts | 02451 | United States | ||
| Davita Clinical Research |
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| Label | URL |
|---|---|
| USA FDA resources | View source |
| Drug Information available for: SNF472 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | SNF472 | SNF472 for Calciphylaxis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SNF472 | SNF472 for calciphylaxis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Healing | Absolute change in Bates-Jensen Wound Assessment (BWAT) total score between baseline (Week 1) and Week 12 for the primary lesion (the largest one). The Bates-Jensen Wound Assessment (BWAT) is a standardized tool for quantitative assessment of wound healing that includes the 13 items listed below.
Each item was rated on a scale of 1 (best) to 5 (worst). The Bates-Jensen Wound Assessment (BWAT) total score is the sum of the individual items with a possible range of 13 (best) to 65 (worst). | Subjects who received at least 1 dose of SNF472 and had at least 1 postbaseline efficacy measurement | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SNF472 | SNF472 for Calciphylaxis | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA version 20 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA version 20 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rekha Garg MD MS | Sanifit | 18582815978 | rekha.garg@sanifit.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2017 | Jul 30, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2018 | Jul 30, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002115 | Calciphylaxis |
| D007676 | Kidney Failure, Chronic |
| D035583 | Rare Diseases |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| C000633406 | SNF472 |
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| 12 weeks |
| Wound-QoL Global Score | Absolute change from baseline (Week 1) and Week 12 in the Wound-QoL global score. The Wound-QoL questionnaire measures the disease-specific, health related QoL of patients with chronic wounds. It consists of 17 items on impairments that are assessed in retrospect to the preceding 7 days and rated on a 0 (best) to 4 (worse) scale with possible responses from "not at all" to "very much". The total score is the average of the 17 responses. | 12 weeks |
| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| Salford Royal Hospital | Salford | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
SNF472 for calciphylaxis |
|
|
|
| Secondary | Wound Pain | Absolute change from baseline (Week 1) and Week 12 in the Pain Visual Analogue Scale (VAS) Score. The Pain Visual Analogue Scale (VAS) Score is a horizontal line, 100 mm in length, anchored by word descriptors at each end. The subject marked the point on the line that represented his/her perception of his/her current pain status. The Pain Visual Analogue Scale (VAS) Score was determined by measuring in millimeters from the left hand end of the line (no pain) to the point that the subject marked. The Pain Visual Analogue Scale (VAS) Score range 0 (best) to 100 (Worst). | Subjects who received at least 1 dose of SNF472 and had at least 1 postbaseline efficacy measurement | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Wound-QoL Global Score | Absolute change from baseline (Week 1) and Week 12 in the Wound-QoL global score. The Wound-QoL questionnaire measures the disease-specific, health related QoL of patients with chronic wounds. It consists of 17 items on impairments that are assessed in retrospect to the preceding 7 days and rated on a 0 (best) to 4 (worse) scale with possible responses from "not at all" to "very much". The total score is the average of the 17 responses. | Subjects who received at least 1 dose of SNF472 and had at least 1 postbaseline efficacy measurement | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
|
| 14 |
| 7 |
| 14 |
| 13 |
| 14 |
| Cardiogenic shock | Cardiac disorders | MedDRA version 20 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA version 20 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 20 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA version 20 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA version 20 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA version 20 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 20 | Systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA version 20 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA version 20 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 20 | Systematic Assessment |
|
| Dry gangrene | Vascular disorders | MedDRA version 20 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA version 20 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA version 20 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 20 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 20 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 20 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 20 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 20 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 20 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 20 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA version 20 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA version 20 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA version 20 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 20 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA version 20 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 20 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 20 | Systematic Assessment |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA version 20 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 20 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA version 20 | Systematic Assessment |
|
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA version 20 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 20 | Systematic Assessment |
|
| Stress fracture | Injury, poisoning and procedural complications | MedDRA version 20 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA version 20 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA version 20 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA version 20 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA version 20 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 20 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA version 20 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 20 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 20 | Systematic Assessment |
|
| Peripheral oedema | General disorders | MedDRA version 20 | Systematic Assessment |
|
| Cellulitis | Investigations | MedDRA version 20 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA version 20 | Systematic Assessment |
|
| Pain in extremities | Musculoskeletal and connective tissue disorders | MedDRA version 20 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA version 20 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA version 20 | Systematic Assessment |
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| Decubitis ulcer | Skin and subcutaneous tissue disorders | MedDRA version 20 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA version 20 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 20 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 20 | Systematic Assessment |
|
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| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |