Phase 2 Study With SNF472 in Calciphylaxis Patients

NCT02790073 | Completed Phase 2 Results

• 1 other identifier: SNFCT2015_04
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 3

Brief Summary

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).

Conditions

Calciphylaxis; Calcific Uremic Arteriolopathy

Keywords

Calciphylaxis; Calcific Uremic Arteriolopathy; Dialysis; End Stage Renal Disease; Rare disease (ORPHA280062); Calcification; Calcium Metabolism Disorders; Calcinosis; Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• 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. * 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).

  12 weeks

Secondary Outcomes (2)

• Wound Pain

  12 weeks

• Wound-QoL Global Score

  12 weeks

Study Arms (1)

SNF472

OTHER

SNF472 for calciphylaxis

Drug: SNF472

Interventions

SNF472 DRUG

SNF472 for calciphylaxis

SNF472

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with either newly diagnosed CUA OR recurrent CUA that has been dormant with no skin lesion involvement for at least 90 days from study start (new or recurrent diagnosis must be made within 5 weeks of study start)
• Patients who signed the written informed consent to participate in this clinical trial (prior to any clinical trial-related procedures being performed), after reading the Patient Information Sheet and Informed Consent Form (ICF), and who had the opportunity to discuss the clinical trial with the Investigator or designee
• Males or females aged ≥18
• Patients on maintenance haemodialysis (HD)
• Patients with at least a minimum level of pain on Visual Analog Scale (VAS) scale or on pain-killers stronger than non-steroidal anti-inflammatory drugs (NSAIDs)
• Females of child-bearing potential should use a highly effective contraceptive measure throughout the study and have a negative serum pregnancy test at entry. Male patients having sexual relationship in which pregnancy can occur should take adequate contraceptive precautions (wear a condom)

You may not qualify if:

• Body weight above 150 kg
• BMI \>35 and central(abdominal) ulcers
• History of bisphosphonate treatment within 12 months before entering into the study
• Severely ill patients without reasonable expectation of survival for \> 6 months according to the treating physician
• Patients with scheduled parathyroidectomy during the run-in or study period
• Female patients who are either intending to get pregnant or are undergoing treatment to get pregnant, as well as breast-feeding females
• Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the patient to comply with the Clinical Trial Protocol requirements
• Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason

Sponsors & Collaborators

• Sanifit Therapeutics S. A.: lead

Study Sites (3)

Fresenius Medical Services

Waltham, Massachusetts, 02451, United States

Location

Davita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Salford Royal Hospital

Salford, United Kingdom

Location

Related Links

• USA FDA resources
• Drug Information available for: SNF472

MeSH Terms

Conditions

Calciphylaxis; Kidney Failure, Chronic; Rare Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases

Interventions

SNF472

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rekha Garg MD MS
• Organization: Sanifit

rekha.garg@sanifit.com

18582815978

Study Officials

• Vincent Brandenburg

  RWTH Aachen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 3, 2016
• Study Start: May 1, 2016
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Locations

US (2); GB (1)