Back to resultsEffect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
Primary Purpose
Cardiovascular Diseases, Cardiovascular Abnormalities, Calcifications, Vascular
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SNF472
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring CAC, calcium, ESRD, calcification, cardiovascular, heart, kidney, hemodialysis, Agatston
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SNF472 300 mg
SNF 472 600 mg
Matching Placebo
Arm Description
Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)
Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)
Placebo arm: 2 vials of physiological saline
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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 .
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.
Full Information
NCT ID
NCT02966028
First Posted
November 15, 2016
Last Updated
March 19, 2021
Sponsor
Sanifit Therapeutics S. A.
Collaborators
Clinipace Worldwide
1. Study Identification
Unique Protocol Identification Number
NCT02966028
Brief Title
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanifit Therapeutics S. A.
Collaborators
Clinipace Worldwide
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Cardiovascular Abnormalities, Calcifications, Vascular, Endstage Renal Disease, ESRD, Coronary Artery Calcification
Keywords
CAC, calcium, ESRD, calcification, cardiovascular, heart, kidney, hemodialysis, Agatston
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SNF472 300 mg
Arm Type
Experimental
Arm Description
Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)
Arm Title
SNF 472 600 mg
Arm Type
Experimental
Arm Description
Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm: 2 vials of physiological saline
Intervention Type
Drug
Intervention Name(s)
SNF472
Intervention Description
Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
Primary Outcome Measure Information:
Title
Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo
Description
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.
Time Frame
Baseline (Week 1, Day 1) and Week 52
Secondary Outcome Measure Information:
Title
Change in Log CAC Volume Score From Baseline to Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo
Description
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.
Time Frame
Baseline (Week 1, Day 1) and Week 52
Title
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
Description
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.
Time Frame
Baseline (Week 1, Day 1) and Week 52
Title
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
Description
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.
Time Frame
Baseline (Week 1, Day 1) and Week 52
Title
Number of Subjects With >=15% Progression in CAC Agatston Score at Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo
Description
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.
Time Frame
Baseline (Week 1, Day 1) and Week 52
Title
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
Description
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.
Time Frame
Baseline (Week 1, Day 1) and Week 52
Title
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
Description
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.
Time Frame
Baseline (Week 1, Day 1) and Week 52
Title
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
Description
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.
Time Frame
Baseline (Week 1, Day 1) and Week 52
Title
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
Description
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.
Time Frame
Baseline (Week 1, Day 1) and Week 52
Title
Number of Participants With the Composite Safety Endpoint (Cardiovascular Death, Nonfatal Myocardial Infarction, Non-fatal Stroke, Heart Failure or Non-fatal Cardiac Arrest.
Description
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 .
Time Frame
Baseline (Week 1, Day 1) and Week 52
Title
Mortality Rate (All-cause) for Each Dose Group and Placebo
Description
The number of deaths were counted and expressed by the randomized arm as a % of patients for the safety population.
Time Frame
Baseline (Week 1, Day 1) and Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Gold, MD
Organizational Affiliation
Sanifit Chief Medical Officer
Official's Role
Study Director
Facility Information:
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80031
Country
United States
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
City
Orange
State/Province
Connecticut
ZIP/Postal Code
06477
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313-1638
Country
United States
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
City
Brookhaven
State/Province
Mississippi
ZIP/Postal Code
39601
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
City
North Brunswick
State/Province
New Jersey
ZIP/Postal Code
08902
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
City
College Point
State/Province
New York
ZIP/Postal Code
11356
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Palma de Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07198
Country
Spain
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08025
Country
Spain
City
Palma
State/Province
Illes Balears
ZIP/Postal Code
07011
Country
Spain
City
Palma
State/Province
Islas Baleares
ZIP/Postal Code
07120
Country
Spain
City
Galdakao
State/Province
Vizcaya
ZIP/Postal Code
48960
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Barcelona
ZIP/Postal Code
08970
Country
Spain
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
City
Lleida
ZIP/Postal Code
25008
Country
Spain
City
Lleida
ZIP/Postal Code
25198
Country
Spain
City
Lugo
ZIP/Postal Code
27003
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Navarro
ZIP/Postal Code
31008
Country
Spain
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
City
Palma
ZIP/Postal Code
07300
Country
Spain
City
Santander
ZIP/Postal Code
39008
Country
Spain
City
Sevilla
ZIP/Postal Code
41007
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
City
Bradford
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
City
Shrewsbury
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
City
Westcliff-on-Sea
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33835939
Citation
Bushinsky 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.
Results Reference
derived
PubMed Identifier
31707860
Citation
Raggi 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.
Results Reference
derived
Learn more about this trial
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
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