Phase 2 Study With SNF472 in Calciphylaxis Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02790073|
Recruitment Status : Completed
First Posted : June 3, 2016
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Calciphylaxis Calcific Uremic Arteriolopathy||Drug: SNF472||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Open Label Single Arm Repeat Dose Study to Assess the Effect of SNF472 on Wound Healing in Uraemic Calciphylaxis Patients|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||November 15, 2017|
|Actual Study Completion Date :||November 15, 2017|
SNF472 for calciphylaxis
SNF472 for calciphylaxis
- Wound Healing [ Time Frame: 12 weeks ]
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.
- Undermining or pockets
- Necrotic tissue type
- Necrotic tissue amount
- Exudate type
- Exudate amount
- Surrounding skin color
- Peripheral tissue edema
- Peripheral tissue induration
- Granulation tissue
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).
- Wound Pain [ Time Frame: 12 weeks ]
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).
- Wound-QoL Global Score [ Time Frame: 12 weeks ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790073
|United States, Massachusetts|
|Fresenius Medical Services|
|Waltham, Massachusetts, United States, 02451|
|United States, Minnesota|
|Davita Clinical Research|
|Minneapolis, Minnesota, United States, 55404|
|Salford Royal Hospital|
|Salford, United Kingdom|
|Principal Investigator:||Vincent Brandenburg||RWTH Aachen University|