Clinical trial NCT02790073: Phase 2 Study With SNF472 in Calciphylaxis Patients
Official title: Phase 2 Open Label Single Arm Repeat Dose Study to Assess the Effect of SNF472 on Wound Healing in Uraemic Calciphylaxis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Sanifit Therapeutics S. A.
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. 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)
2. 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
3. Males or females aged ≥18
4. Patients on maintenance haemodialysis (HD)
5. 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)
6. 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)

Exclusion Criteria:

1. Body weight above 150 kg
2. BMI \>35 and central(abdominal) ulcers
3. History of bisphosphonate treatment within 12 months before entering into the study
4. Severely ill patients without reasonable expectation of survival for \> 6 months according to the treating physician
5. Patients with scheduled parathyroidectomy during the run-in or study period
6. Female patients who are either intending to get pregnant or are undergoing treatment to get pregnant, as well as breast-feeding females
7. Participation in another clinical trial with an experimental drug within 90 days prior the inclusion
8. 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
9. Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason

Primary outcomes:
measure: Wound Healing
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound Pain
timeFrame: 12 weeks
measure: Wound-QoL Global Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Fresenius Medical Services
state: Massachusetts
city: Minneapolis
country: United States
facility: Davita Clinical Research
state: Minnesota
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
Study officials:
affiliation: RWTH Aachen University
name: Vincent Brandenburg
role: PRINCIPAL_INVESTIGATOR
References: