Phase 3 Study of SNF472 for Calciphylaxis

NCT04195906 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: SNFCT2017-06
• Study Type: interventional
• Target: 71
• Locations: 6 countries
• Sites: 58

Brief Summary

The primary objectives are to assess the efficacy, safety, and tolerability of SNF472 compared to placebo when added to background care for the treatment of calciphylaxis (CUA).

Conditions

Calciphylaxis; Calcific Uremic Arteriolopathy

Keywords

Calciphylaxis; Calcific Uremic Arteriolopathy; Wound; ESRD

Outcome Measures

Primary Outcomes (2)

• Absolute Change in the BWAT - CUA Score for the Primary Lesion

  The Bates Jensen Wound Assessment Tool (BWAT) CUA score ranges from a minimum score of 8 (best) to a maximum score of 40 (worst). BWAT-CUA= Bates-Jensen Wound Assessment Tool-Calcific Uremic Arteriolopathy

  from Baseline to Week 12

• Absolute Change in Pain Visual Analog Score

  The Pain Visual Analog Scale (VAS) score ranges from a minimum score of 0 (no pain) to 100 (worst possible pain).

  from Baseline to Week 12

Secondary Outcomes (4)

• Absolute Change in the Wound-Quality of Life Score

  from Baseline to Week 12

• Absolute Change in the BWAT Total Score for the Primary Lesion

  from Baseline to Week 12

• Qualitative Wound Image Evaluation for the Primary Lesion

  at Week 12

• Rate of Change in Opioid Use as Measured in Morphine Milligram Equivalents (MME)

  from Baseline to Week 12

Study Arms (3)

SNF472 (Double-Blind Period)

EXPERIMENTAL

Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.

Drug: Experimental: SNF472

Placebo (Double-Blind Period)

PLACEBO COMPARATOR

Matching placebo (saline) diluted in 100 mL physiological saline.

Drug: Placebo Comparator: Placebo

SNF472 (Open-Label)

EXPERIMENTAL

Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline.

Drug: Experimatenl SNF472 (Open-label)

Interventions

Experimental: SNF472 DRUG

Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks

SNF472 (Double-Blind Period)

Placebo Comparator: Placebo DRUG

Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions fo 12 weeks

Also known as: Saline

Placebo (Double-Blind Period)

Experimatenl SNF472 (Open-label) DRUG

Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks

SNF472 (Open-Label)

Eligibility Criteria

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

You may qualify if:

• Female or male subjects, 18 years of age or older
• Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening
• Clinical diagnosis of CUA by the Investigator including ≥1 CUA lesion with ulceration of the epithelial surface
• CUA wound-related pain shown by a Pain VAS score ≥50 out of 100
• Primary lesion that can be clearly photographed for the purpose of protocol-specified wound healing assessments.
• Willing and able to understand and sign the informed consent form and willing to comply with all aspects of the protocol

You may not qualify if:

• History of treatment with bisphosphonates within 3 months of baseline
• Severely ill subjects without a reasonable expectation of survival for at least 6 months
• Subjects with a scheduled parathyroidectomy during the study period
• Expectation for kidney transplant within the next 6 months based on Investigator assessment or identification of a known living donor
• Pregnant or trying to become pregnant, currently breastfeeding, or of childbearing potential (including perimenopausal women who have had a menstrual period within one year) and not willing to comply with protocol required contraception criteria
• Significant noncompliance with dialysis
• History of active malignancy within the last year with the exception of localized basal cell or squamous cell carcinoma
• Clinically significant illness other than CUA within 30 days
• Participation in an investigational study and receipt of an investigational drug or investigational use of a licensed drug within 30 days prior to screening.
• History or presence of active alcoholism or drug abuse as determined by the Investigator within 6 months
• Mental impairment, current significant psychiatric disease, or other conditions or circumstances that would make the subject unlikely to complete the study or comply with the study procedures.
• Subjects whose CUA lesions exhibit significant improvement, in the opinion of the Investigator, between the first and second screening visit

Sponsors & Collaborators

• Sanifit Therapeutics S. A.: lead

Study Sites (58)

AKDHC Medical Research Services

Phoenix, Arizona, 85035, United States

Location

California Institute of Renal Research

El Centro, California, 92243, United States

Location

California Institute of Renal Research

Escondido, California, 92027, United States

Location

Kidney Disease Medical Group

Glendale, California, 91204, United States

Location

DaVita Clinical Research

Lynwood, California, 90260, United States

Location

Apex Research of Riverside

Riverside, California, 92505, United States

Location

Fresenius Kidney Care

San Diego, California, 92111, United States

Location

North America Research Institute

San Dimas, California, 91773, United States

Location

Amicis Research Center

Vacaville, California, 95687, United States

Location

Colorado Kidney Care

Denver, Colorado, 80230, United States

Location

Boca Nephrology, PA

Boca Raton, Florida, 33431, United States

Location

DaVita Clinical Research

Hollywood, Florida, 33024, United States

Location

Novel Outcomes Research

Spring Hill, Florida, 34667, United States

Location

DaVita Clinical Research

Tampa, Florida, 33614, United States

Location

Fresenius Kidney Care

Tampa, Florida, 33614, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Michigan Kidney Consultants

Pontiac, Michigan, 48341, United States

Location

DaVita Clinical Research

Roseville, Michigan, 48066, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Fresenius Kidney Care

Brookhaven, Mississippi, 39601, United States

Location

DaVita Clinical Research

Kansas City, Missouri, 64111, United States

Location

DaVita Clinical Research

Las Vegas, Nevada, 89128, United States

Location

Fresenius Kidney Care

Reno, Nevada, 89511, United States

Location

DaVita Clinical Research

The Bronx, New York, 10461, United States

Location

DaVita Clinical Research

Asheville, North Carolina, 28801, United States

Location

Fresenius Kidney Care

Durham, North Carolina, 22704, United States

Location

Piedmont Dialysis Center

Winston-Salem, North Carolina, 27101, United States

Location

Hypertension Nephrology Consultants, Inc

Columbus, Ohio, 43215, United States

Location

Fresenius Kidney Care

Bethlehem, Pennsylvania, 18017, United States

Location

DaVita Clinical Research

Chester, Pennsylvania, 19013, United States

Location

Fresenius Kidney Care

Columbia, South Carolina, 29203, United States

Location

Knoxville Kidney Center

Knoxville, Tennessee, 37923, United States

Location

DaVita Clinical Research

Houston, Texas, 77004, United States

Location

Clinical Advancement Center

San Antonio, Texas, 78212, United States

Location

DaVita Clinical Research

Chesapeake, Virginia, 23320, United States

Location

DaVita Clinical Research

Norfolk, Virginia, 23502, United States

Location

Fresenius Kidney Care

Roanoke, Virginia, 24014, United States

Location

DaVita Clinical Research

Wauwatosa, Wisconsin, 53226, United States

Location

Clinques Universitaries de Bruxelles Hopital

Brussels, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

AZ Delta

Roeselare, Belgium

Location

Nephrologischen Zentrum Villingen-Schwenningen

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, Germany

Location

DaVita Deutschland AG

Düsseldorf, Germany

Location

Centrum Dializ Fresenius, Ośrodek Dializ nr 10 w Bydgoszczy 85-826

Bydgoszcz, Poland

Location

Centrum Dializ Fresenius, Ośrodek Dializ nr 18 w Krakowie..

Krakow, Poland

Location

Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi Stacja Dializ,

Lodz, Poland

Location

DaVita Sp. z o.o., Stacja Dializ w Miechowie

Miechów, Poland

Location

Centrum Dializ Fresenius Ośrodek Dializ nr 32 w Radomiu 26-617 .

Radom, Poland

Location

Fundacio Puigvert

Barcelona, 08025, Spain

Location

University of Barcelona Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, Spain

Location

Royal Devon and Exeter Hospital (Wonford)

Exeter, Devon, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

Leicester General Hospital

Leicester, Leicestershire, le5 4pw, United Kingdom

Location

Queen Elizabeth University Hospital Campus

Glasgow, Strathclyde, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, West Midlands, United Kingdom

Location

Kings College Hospital

London, SE59RS, United Kingdom

Location

Related Publications (2)

• Sinha S, Nigwekar SU, Brandenburg V, Gould LJ, Serena TE, Moe SM, Aronoff GR, Chatoth DK, Hymes JL, Carroll KJ, Alperovich G, Keller LH, Perello J, Gold A, Chertow GM. Hexasodium fytate for the treatment of calciphylaxis: a randomised, double-blind, phase 3, placebo-controlled trial with an open-label extension. EClinicalMedicine. 2024 Aug 16;75:102784. doi: 10.1016/j.eclinm.2024.102784. eCollection 2024 Sep.

  PMID: 39252867 DERIVED

• Krishnasamy R, Jardine MJ; BEAT-Calci Trialists. Adaptive Designs for Clinical Trials in Nephrology. J Am Soc Nephrol. 2025 Jan 1;36(1):147-149. doi: 10.1681/ASN.0000000000000497. Epub 2024 Aug 26. No abstract available.

  PMID: 39186385 DERIVED

MeSH Terms

Conditions

Calciphylaxis; Wounds and Injuries; Kidney Failure, Chronic

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; 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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Peter Szecsödy
• Organization: Sanifit Therapeutics S. A.

clinicaltrials@cslbehring.com

+41588529079

Study Officials

• Alex Gold, MD

  Sanifit Therapeutics

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: February 12, 2020
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: February 20, 2024
• Results First Posted: February 20, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6); PL (5); BE (3); US (38); DE (3); ES (3)