Cardiovascular DiseasesPhase 2NCT02966028
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
A Phase 2 study testing SNF472 in people with Cardiovascular Diseases and Cardiovascular Abnormalities, run by Sanifit Therapeutics S. A. at 75 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Abnormalities, Calcifications, Vascular
- What is being tested?
- SNF472
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 75 sitesin 3 countries
- Study dates
- Nov 2016to Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
75 sites in 3 countries.
75 sites in 3 countries
United States46 sites
Study site
Arlington, Texas, 76015
Study site
Arvada, Colorado, 80002
Study site
Asheville, North Carolina, 28801
Study site
Bakersfield, California, 93308
Study site
Bethlehem, Pennsylvania, 18017
Study site
Brookhaven, Mississippi, 39601
Study site
Chesapeake, Virginia, 23320
Study site
Chula Vista, California, 91910
Study site
Cincinnati, Ohio, 45267
Study site
College Point, New York, 11356
Study site
Escondido, California, 92025
Study site
Evanston, Illinois, 60201
Study site
Granada Hills, California, 91344
Study site
Hollywood, Florida, 33024
Study site
Houston, Texas, 77024
Study site
Houston, Texas, 77099
Study site
Knoxville, Tennessee, 37923
Study site
La Palma, California, 90623
Study site
Las Vegas, Nevada, 89106
Study site
Lauderdale Lakes, Florida, 33313-1638
Study site
Long Beach, California, 90807
Study site
Los Angeles, California, 90048
Study site
Lynwood, California, 90262
Study site
Miami, Florida, 33133
Study site
Miami Gardens, Florida, 33169
Study site
Middlebury, Connecticut, 06762
Study site
North Brunswick, New Jersey, 08902
Study site
Northridge, California, 91324
Study site
Ocala, Florida, 34471
Study site
Orange, Connecticut, 06477
Study site
Pontiac, Michigan, 48341
Study site
Reno, Nevada, 89511
Study site
Richardson, Texas, 75080
Study site
Riverside, California, 92505
Study site
Roseville, Michigan, 48066
Study site
San Antonio, Texas, 78207
Study site
San Diego, California, 92111
Study site
San Dimas, California, 91773
Study site
Shreveport, Louisiana, 71101
Study site
Simi Valley, California, 93065
Study site
Tampa, Florida, 33614
Study site
Tarzana, California, 91356
Study site
The Bronx, New York, 10461
Study site
Wauwatosa, Wisconsin, 53226
Study site
Westminster, Colorado, 80031
Study site
Whittier, California, 90603
Spain23 sites
Study site
Barcelona, Catalonia, 08025
Study site
Barcelona, 08003
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Barcelona, 08208
Study site
Barcelona, 08970
Study site
Córdoba, 14004
Study site
Galdakao, Vizcaya, 48960
Study site
Lleida, 25008
Study site
Lleida, 25198
Study site
Lugo, 27003
Study site
Madrid, 28040
Study site
Navarro, 31008
Study site
Oviedo, 33011
Study site
Palma, Balearic Islands, 07011
Study site
Palma, Balearic Islands, 07120
Study site
Palma, 07300
Study site
Palma de Mallorca, Balearic Islands, 07198
Study site
Santander, 39008
Study site
Seville, 41007
Study site
Valencia, 46010
Study site
Valencia, 46017
Study site
Zaragoza, 50009
United Kingdom6 sites
Study site
Bradford, BD5 0NA
Study site
Manchester, M13 9WL
Study site
Salford, M6 8HD
Study site
Shrewsbury, SY3 8XQ
Study site
Swansea, SA6 6NL
Study site
Westcliff-on-Sea, SS0 0RY
About this study
Official title: 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)
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
Read the detailed description
Reducing the progression of cardiovascular calcification (CVC) in HD patients may improve the severe burden of CV disease related to the underlying ESRD. As no therapy is currently indicated to target CVC, there is a need to investigate the ability of SNF472 to reduce CVC progression and, ultimately, to improve CV outcomes in HD patients. This phase 2b double-blind, randomised, placebo-controlled study is designed to assess the effect of SNF472 on the progression of CVC as measured by calcium volume and CAC/Agatston scores in ESRD patients receiving HD. The study hypothesis is that administration of SNF472 over 52 weeks can slow the progression of CVC in this patient population compared to placebo.
- Conditions
- Cardiovascular Diseases, Cardiovascular Abnormalities, Calcifications, Vascular, Endstage Renal Disease, ESRD, Coronary Artery Calcification
- Being tested
- SNF472, Placebo
- Keywords
- CAC, calcium, ESRD, calcification, cardiovascular, heart, kidney, hemodialysis, Agatston
- Medical subject headings
- Cardiovascular Diseases, Cardiovascular Abnormalities, Vascular Calcification, Kidney Failure, Chronic, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNF472Drug
Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
PlaceboDrug
Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
| Study group | Role | What they receive |
|---|---|---|
| SNF472 300 mg | Experimental | Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL) Receives: Drug: SNF472 |
| SNF 472 600 mg | Experimental | Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL) Receives: Drug: SNF472 |
| Matching Placebo | Placebo comparator | Placebo arm: 2 vials of physiological saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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. This secondary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for each dose group vs placebo. The 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 each randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for each of the treatment groups was estimated and back transformed.
A smaller change from baseline to follow up is a better outcome.
Measured: 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
Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in Log CAC Agatston Score from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed.
Measured: 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
Agatston score is a semi-automated tool to calculate a score that reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. Change in Agatston Score values from baseline to Week 52 were calculated as a percentage of change (progression or worsening of calcification). The number of subjects with <15% progression were counted.
Measured: 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
Agatston score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. Change in Agatston Score values from baseline to Week 52 was calculated as a percentage of change (progression or worsening of calcification). The number of subjects with >=15% progression were counted for each treatment group, the combined treatments groups and placebo.
Measured: 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
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 volume score observed in the thoracic aorta was used for this analysis. The CAC volume 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 and each dose group vs placebo. The secondary 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.
Measured: Baseline (Week 1, Day 1) and Week 52
Change in Log Thoracic Aorta Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo
Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score that reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in CAC Agatston Score in the thoracic aorta from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.
Measured: Baseline (Week 1, Day 1) and Week 52
Change in Log Aortic Valve 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
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 volume score observed in the aortic valve was used for this analysis. The CAC volume 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 and each dose group vs placebo. The secondary 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.
Measured: Baseline (Week 1, Day 1) and Week 52
Change in Log Aortic Valve Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo
Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in Log CAC Agatston Score or the aortic valve from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed. A smaller change from baseline to follow up is a better outcome.
Measured: Baseline (Week 1, Day 1) and Week 52
Number of Participants With the Composite Safety Endpoint (Cardiovascular Death, Nonfatal Myocardial Infarction, Non-fatal Stroke, Heart Failure or Non-fatal Cardiac Arrest.
The number of subjects meeting this composite safety endpoint were counted and expressed by the randomized arm as a % of patients for the safety population.terms resulting in death from cardiovascular causes, myocardial infarction, stroke, or heart failure for each dose group and placebo were summarized .
Measured: Baseline (Week 1, Day 1) and Week 52
Mortality Rate (All-cause) for Each Dose Group and Placebo
The number of deaths were counted and expressed by the randomized arm as a % of patients for the safety population.
Measured: Baseline (Week 1, Day 1) and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanifit Therapeutics S. A.
- Sponsor type
- University, hospital or other
- Collaborators
- Clinipace Worldwide
- Responsible party
- Sponsor
- Investigators
- Alex Gold, MD, Study director, Sanifit Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966028
- Sponsor's protocol ID
- SNFCT2015-05
- Status last verified
- Mar 2021
- First submitted
- 15 Nov 2016
- Last updated
- 15 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 38384289Bushinsky 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.
PubMed 33835939Raggi 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.
PubMed 31707860
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02966028
- Acronym / sponsor ID
- SNFCT2015-05
- Conditions
- Cardiovascular Diseases, Cardiovascular Abnormalities, Calcifications, Vascular, Endstage Renal Disease, ESRD, Coronary Artery Calcification
- Keywords
- CAC, calcium, ESRD, calcification, cardiovascular, heart, kidney, hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Sanifit Therapeutics S. A.University, hospital or other
- Collaborators
- Clinipace Worldwide
- Study start
- Nov 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Reducing the progression of cardiovascular calcification (CVC) in HD patients may improve the severe burden of CV disease related to the underlying ESRD. As no therapy is currently indicated to target CVC, there is a need to investigate the ability of SNF472 to reduce CVC progression and, ultimately, to improve CV outcomes in HD patients. This phase 2b double-blind, randomised, placebo-controlled study is designed to assess the effect of SNF472 on the progression of CVC as measured by calcium volume and CAC/Agatston scores in ESRD patients receiving HD. The study hypothesis is that administration of SNF472 over 52 weeks can slow the progression of CVC in this patient population compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SNF472 300 mg | Experimental | Drug: SNF472Dose 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 | Experimental | Drug: SNF472Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL) |
| Matching Placebo | Placebo comparator | Drug: PlaceboPlacebo arm: 2 vials of physiological saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNF472Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions. | Drug | SNF 472 600 mg, SNF472 300 mg |
| PlaceboAdministered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions. | Drug | Matching Placebo |
Primary outcome
Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo
Time frame: Baseline (Week 1, Day 1) and Week 52
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.
10 secondary outcomes
Change in Log CAC Volume Score From Baseline to Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (Week 1, Day 1) and Week 52
Change in Log Thoracic Aorta Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo
Time frame: Baseline (Week 1, Day 1) and Week 52
Change in Log Aortic Valve 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
Time frame: Baseline (Week 1, Day 1) and Week 52
Change in Log Aortic Valve Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo
Time frame: Baseline (Week 1, Day 1) and Week 52
Number of Participants With the Composite Safety Endpoint (Cardiovascular Death, Nonfatal Myocardial Infarction, Non-fatal Stroke, Heart Failure or Non-fatal Cardiac Arrest.
Time frame: Baseline (Week 1, Day 1) and Week 52
Mortality Rate (All-cause) for Each Dose Group and Placebo
Time frame: Baseline (Week 1, Day 1) and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38384289Perello 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.
- Derived from this study: PubMed 33835939Bushinsky 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.
- Derived from this study: PubMed 31707860Raggi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Gold, MD study director
Sanifit Chief Medical Officer
75 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNF472 in people with Cardiovascular Diseases and Cardiovascular Abnormalities, run by Sanifit Therapeutics S. A. at 75 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo (time frame: Baseline (Week 1, Day 1) and Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02966028, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.