Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
A Double-blind, Randomised, Placebo-controlled Study to Assess the Effect of SNF472 on Progression of Cardiovascular Calcification on Top of Standard of Care in End-stage-renal-disease (ESRD) Patients on Hemodialysis (HD)
1 other identifier
interventional
274
3 countries
75
Brief Summary
The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg) compared to placebo on the progression of coronary artery calcium volume score over a 12-month (52 weeks) period in ESRD patients on HD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cardiovascular-diseases
Started Nov 2016
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 15, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedResults Posted
Study results publicly available
March 16, 2021
CompletedApril 15, 2021
March 1, 2021
2.7 years
November 15, 2016
August 31, 2020
March 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo
Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. The primary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.
Baseline (Week 1, Day 1) and Week 52
Secondary Outcomes (10)
Change in Log CAC Volume Score From Baseline to Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo
Baseline (Week 1, Day 1) and Week 52
Change in Log CAC Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and for the Combined Dose Groups vs the Placebo Group
Baseline (Week 1, Day 1) and Week 52
Number of Subjects With <15% Progression in CAC Agatston Score From Baseline to Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo
Baseline (Week 1, Day 1) and Week 52
Number of Subjects With >=15% Progression in CAC Agatston Score at Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo
Baseline (Week 1, Day 1) and Week 52
Change in Log Thoracic Aorta Calcification Volume Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo
Baseline (Week 1, Day 1) and Week 52
- +5 more secondary outcomes
Study Arms (3)
SNF472 300 mg
EXPERIMENTALDose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)
SNF 472 600 mg
EXPERIMENTALDose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)
Matching Placebo
PLACEBO COMPARATORPlacebo arm: 2 vials of physiological saline
Interventions
Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
Eligibility Criteria
You may qualify if:
- Female or male patients, 18 to 80 years (inclusive) of age at randomisation
- CAC score of 100 to 3500 AU (Agatston Units) inclusive within a 3-week period prior to randomisation as measured by a multi-detector CT scanner
- Patients who are EITHER ≥ 55 years OR have a history of diabetes mellitus at randomisation
- Patients on HD for ≥ 6 months prior to randomisation
- Willing and able to understand and sign the informed consent
You may not qualify if:
- Scheduled date for kidney transplant from a known living donor
- Weight above 300 lbs (136 kg)
- Hospitalisation in the previous 3 months prior to randomisation for unstable angina, MI, stroke, transient ischaemic attack, amputation or peripheral or coronary bypass surgery
- History of unstable heart failure in the previous 3 months, defined as an unplanned presentation to a hospital or dialysis treatment facility with signs/symptoms of acute pulmonary edema and requiring ultrafiltration therapy
- History of cancer that has been in remission for \< 5 years prior to randomisation. A history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed
- Pregnant or trying to become pregnant, currently breast-feeding, or of child-bearing potential (including peri-menopausal women who have had a menstrual period within one year) and not willing to practice birth control using a double barrier method (criteria apply to women only) at least 30 days post last dose of study medication
- Hypocalcaemia defined as a serum calcium below 8.0 mg/dL (or 2.0 mmol/L) for the serum calcium most proximal to screening per patient's medical records
- Extreme elevation in serum phosphorous, defined as a serum phosphorous above 10 mg/dL (or 3.23 mmol/L) within the last 2 months proximal to screening per patient's medical records
- Uncontrolled hypertension defined as any 2 or more consecutive post-dialysis diastolic blood pressure (DBP) \> 100 mmHg within the last 2 months proximal to screening expected survival \< 2 years in the Investigator's medical opinion
- Known active drug or alcohol abuse within 1 year of randomisation
- Use of other investigational drugs within 30 days of randomisation
- Non-compliance with dialysis treatment which, in the opinion of the Investigator, evidenced by either repeated missed dialysis treatments or significant non-compliance with the patient's medication regimen
- Inability to comply with all required study procedures and schedule, inability to speak and read in the protocol-derived language of that patient's clinical site, or unwillingness or inability to give written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanifit Therapeutics S. A.lead
- Clinipace Worldwidecollaborator
Study Sites (75)
Unknown Facility
Bakersfield, California, 93308, United States
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Chula Vista, California, 91910, United States
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Escondido, California, 92025, United States
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Granada Hills, California, 91344, United States
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La Palma, California, 90623, United States
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Long Beach, California, 90807, United States
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Los Angeles, California, 90048, United States
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Lynwood, California, 90262, United States
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Northridge, California, 91324, United States
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Riverside, California, 92505, United States
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San Diego, California, 92111, United States
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San Dimas, California, 91773, United States
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Simi Valley, California, 93065, United States
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Tarzana, California, 91356, United States
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Whittier, California, 90603, United States
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Arvada, Colorado, 80002, United States
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Westminster, Colorado, 80031, United States
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Middlebury, Connecticut, 06762, United States
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Orange, Connecticut, 06477, United States
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Hollywood, Florida, 33024, United States
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Lauderdale Lakes, Florida, 33313-1638, United States
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Miami, Florida, 33133, United States
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Miami Gardens, Florida, 33169, United States
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Ocala, Florida, 34471, United States
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Tampa, Florida, 33614, United States
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Evanston, Illinois, 60201, United States
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Shreveport, Louisiana, 71101, United States
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Pontiac, Michigan, 48341, United States
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Roseville, Michigan, 48066, United States
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Brookhaven, Mississippi, 39601, United States
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Las Vegas, Nevada, 89106, United States
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Reno, Nevada, 89511, United States
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North Brunswick, New Jersey, 08902, United States
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College Point, New York, 11356, United States
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The Bronx, New York, 10461, United States
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Asheville, North Carolina, 28801, United States
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Cincinnati, Ohio, 45267, United States
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Bethlehem, Pennsylvania, 18017, United States
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Knoxville, Tennessee, 37923, United States
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Arlington, Texas, 76015, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77099, United States
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Richardson, Texas, 75080, United States
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San Antonio, Texas, 78207, United States
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Chesapeake, Virginia, 23320, United States
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Wauwatosa, Wisconsin, 53226, United States
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Palma, Balearic Islands, 07011, Spain
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Palma, Balearic Islands, 07120, Spain
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Palma de Mallorca, Balearic Islands, 07198, Spain
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Barcelona, Catalonia, 08025, Spain
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Galdakao, Vizcaya, 48960, Spain
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Barcelona, 08003, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08208, Spain
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Barcelona, 08970, Spain
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Córdoba, 14004, Spain
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Lleida, 25008, Spain
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Lleida, 25198, Spain
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Lugo, 27003, Spain
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Madrid, 28040, Spain
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Navarro, 31008, Spain
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Oviedo, 33011, Spain
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Palma, 07300, Spain
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Santander, 39008, Spain
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Seville, 41007, Spain
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Valencia, 46010, Spain
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Valencia, 46017, Spain
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Zaragoza, 50009, Spain
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Bradford, BD5 0NA, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Salford, M6 8HD, United Kingdom
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Shrewsbury, SY3 8XQ, United Kingdom
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Swansea, SA6 6NL, United Kingdom
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Westcliff-on-Sea, SS0 0RY, United Kingdom
Related Publications (3)
Perello J, Alberti J, Torres JV, Ferrer MD, Perez MM, Bassissi F, Gold A, Raggi P, Chertow GM, Salcedo C. Hexasodium fytate exposure-response correlations in a randomized, placebo-controlled study of patients on dialysis with cardiovascular calcification. Front Pharmacol. 2024 Feb 7;15:1325186. doi: 10.3389/fphar.2024.1325186. eCollection 2024.
PMID: 38384289DERIVEDBushinsky DA, Raggi P, Bover J, Ketteler M, Bellasi A, Rodriguez M, Sinha S, Garg R, Perello J, Gold A, Chertow GM; CaLIPSO Investigators*; CaLIPSO Study Group and Clinipace GmbH, Intrinsic Imaging, LLC. Effects of Myo-inositol Hexaphosphate (SNF472) on Bone Mineral Density in Patients Receiving Hemodialysis: An Analysis of the Randomized, Placebo-Controlled CaLIPSO Study. Clin J Am Soc Nephrol. 2021 May 8;16(5):736-745. doi: 10.2215/CJN.16931020. Epub 2021 Apr 7.
PMID: 33835939DERIVEDRaggi P, Bellasi A, Bushinsky D, Bover J, Rodriguez M, Ketteler M, Sinha S, Salcedo C, Gillotti K, Padgett C, Garg R, Gold A, Perello J, Chertow GM. Slowing Progression of Cardiovascular Calcification With SNF472 in Patients on Hemodialysis: Results of a Randomized Phase 2b Study. Circulation. 2020 Mar 3;141(9):728-739. doi: 10.1161/CIRCULATIONAHA.119.044195. Epub 2019 Nov 11.
PMID: 31707860DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- SVP Clinical Development Operations
- Organization
- Sanifit
Study Officials
- STUDY DIRECTOR
Alex Gold, MD
Sanifit Chief Medical Officer
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
November 15, 2016
First Posted
November 17, 2016
Study Start
November 1, 2016
Primary Completion
August 1, 2019
Study Completion
September 1, 2019
Last Updated
April 15, 2021
Results First Posted
March 16, 2021
Record last verified: 2021-03