Trial Outcomes & Findings for Phase 2 Study With SNF472 in Calciphylaxis Patients (NCT NCT02790073)
NCT ID: NCT02790073
Last Updated: 2019-08-28
Results Overview
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. * Size * Depth * Edges * Undermining or pockets * Necrotic tissue type * Necrotic tissue amount * Exudate type * Exudate amount * Surrounding skin color * Peripheral tissue edema * Peripheral tissue induration * Granulation tissue * Epithelialization 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).
COMPLETED
PHASE2
14 participants
12 weeks
2019-08-28
Participant Flow
Participant milestones
| Measure |
SNF472
SNF472 for Calciphylaxis
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
SNF472
SNF472 for Calciphylaxis
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal from HD
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase 2 Study With SNF472 in Calciphylaxis Patients
Baseline characteristics by cohort
| Measure |
SNF472
n=14 Participants
SNF472 for calciphylaxis
|
|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Subjects who received at least 1 dose of SNF472 and had at least 1 postbaseline efficacy measurement
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. * Size * Depth * Edges * Undermining or pockets * Necrotic tissue type * Necrotic tissue amount * Exudate type * Exudate amount * Surrounding skin color * Peripheral tissue edema * Peripheral tissue induration * Granulation tissue * Epithelialization 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).
Outcome measures
| Measure |
SNF472
n=14 Participants
SNF472 for calciphylaxis
|
|---|---|
|
Wound Healing
|
-8.1 units on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Subjects who received at least 1 dose of SNF472 and had at least 1 postbaseline efficacy measurement
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).
Outcome measures
| Measure |
SNF472
n=14 Participants
SNF472 for calciphylaxis
|
|---|---|
|
Wound Pain
|
-23.6 units on a scale
Standard Deviation 30.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Subjects who received at least 1 dose of SNF472 and had at least 1 postbaseline efficacy measurement
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.
Outcome measures
| Measure |
SNF472
n=14 Participants
SNF472 for calciphylaxis
|
|---|---|
|
Wound-QoL Global Score
|
-0.9 units on a scale
Standard Deviation 0.87
|
Adverse Events
SNF472
Serious adverse events
| Measure |
SNF472
n=14 participants at risk
SNF472 for Calciphylaxis
|
|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Cardiogenic shock
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Haematemesis
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Cellulitis
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Gangrene
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Infection
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
Fluid overload
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Vascular disorders
Dry gangrene
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Vascular disorders
Hypertensive emergency
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
SNF472
n=14 participants at risk
SNF472 for Calciphylaxis
|
|---|---|
|
Cardiac disorders
Tachycardia
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
2/14 • Number of events 2 • 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • Number of events 2 • 12 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
General disorders
Asthenia
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
General disorders
Chest discomfort
|
7.1%
1/14 • Number of events 2 • 12 weeks
|
|
General disorders
Peripheral swelling
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Anal abscess
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Cellulitis
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Conjunctivitis
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
14.3%
2/14 • Number of events 2 • 12 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Stress fracture
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Wound complication
|
7.1%
1/14 • Number of events 6 • 12 weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
14.3%
2/14 • Number of events 2 • 12 weeks
|
|
Investigations
Haemoglobin decreased
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Investigations
Oxygen saturation decreased
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
1/14 • Number of events 4 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
General disorders
Peripheral oedema
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Investigations
Cellulitis
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
Fluid overload
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremities
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Dyskinesia
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
14.3%
2/14 • Number of events 5 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Decubitis ulcer
|
7.1%
1/14 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
14.3%
2/14 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
7.1%
1/14 • Number of events 2 • 12 weeks
|
|
Vascular disorders
Hypertension
|
14.3%
2/14 • Number of events 3 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60