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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).
The formation and growth of calcified deposits in arterioles and other small blood vessels appears to be fundamental to the development of CUA especially in end stage renal disease patients. This phase 3 double-blind, randomized, placebo-controlled study is designed to assess the effect of SNF472 when added to background care to improve wound healing, as evaluated using Bates-Jensen Wound Assessment Tool (BWAT) scoring and pain as reported by the subject using a VAS scale. The study consists of a double-blind, randomized, placebo controlled period of 12 weeks followed by an open-label period of 12 weeks.. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNF472 (Double-Blind Period) | Experimental | Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. |
|
| Placebo (Double-Blind Period) | Placebo Comparator | Matching placebo (saline) diluted in 100 mL physiological saline. |
|
| SNF472 (Open-Label) | Experimental | Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in the Wound-Quality of Life Score | The Wound Quality of Life scale is a validated self-assessment tool that has been shown to be feasible for assessing health-related quality of life in patients with chronic wounds. Lower scores are associated with a better quality of life as reported by the patient. The score is computed by averaging the 17 items on impairments assessed on a scale of 0 to 4 for the preceding 7 days. A global score can only be computed if at least 75% of the items have been answered, i.e., at least 13 in 17 items are valid. All the available items' scores were added up and divided by 17. In case of missing assessments for any one of the 17 items, the median of the scores for a particular item within the associated randomized treatment group was used for the imputation purposes. As the absolute change from baseline is reported, a higher negative value is associated with a higher improvement of quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Gold, MD | Sanifit Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKDHC Medical Research Services | Phoenix | Arizona | 85035 | United States | ||
| California Institute of Renal Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39252867 | Derived | 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. | |
| 39186385 |
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A total of 148 participants were screened in 48 sites in 5 countries; 77 participants were not enrolled because they were screen failures (did not meet eligibility criteria). A total of 71 participants were randomized in the study to receive SNF472 or placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | SNF472 (Double-blind Period + Open-label) | Part 1 (double-blind period): Participants received SNF472 for 12 weeks in addition to their background care. Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks. Part 2 (Open-label): Participants received SNF472 for 12 weeks in addition to their background care. Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2021 | Nov 14, 2023 |
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| 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 |
|
|
| 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 |
|
| from Baseline to Week 12 |
| Absolute Change in the BWAT Total Score for the Primary Lesion | The Bates Jensen Wound Assessment Tool (BWAT) score ranges from a minimum score of 9 (best) to a maximum score of 65 (worst) score. | from Baseline to Week 12 |
| Qualitative Wound Image Evaluation for the Primary Lesion | A qualitative assessment (Worsened, Equal to, or Improved Relative to Baseline) was assigned | at Week 12 |
| Rate of Change in Opioid Use as Measured in Morphine Milligram Equivalents (MME) | Change from baseline in opioid use MME = Morphine Milligram Equivalents The calculation of the pre-specified list of opioids was based on the formula: strength per unit × (number of units/days supply) × MME conversion factor = MME/day, as specified in the opioid MME conversion guide (CMS, 2017). The maintenance opioid dose was defined as the average daily opioid dose in MME during the 7-day period prior to Screening Visit 2. To assess the extent to which opioid use may have differed between randomized treatment groups over time, the change from baseline in daily average MME value was analyzed. | from Baseline to Week 12 |
| El Centro |
| California |
| 92243 |
| United States |
| California Institute of Renal Research | Escondido | California | 92027 | United States |
| Kidney Disease Medical Group | Glendale | California | 91204 | United States |
| DaVita Clinical Research | Lynwood | California | 90260 | United States |
| Apex Research of Riverside | Riverside | California | 92505 | United States |
| Fresenius Kidney Care | San Diego | California | 92111 | United States |
| North America Research Institute | San Dimas | California | 91773 | United States |
| Amicis Research Center | Vacaville | California | 95687 | United States |
| Colorado Kidney Care | Denver | Colorado | 80230 | United States |
| Boca Nephrology, PA | Boca Raton | Florida | 33431 | United States |
| DaVita Clinical Research | Hollywood | Florida | 33024 | United States |
| Novel Outcomes Research | Spring Hill | Florida | 34667 | United States |
| DaVita Clinical Research | Tampa | Florida | 33614 | United States |
| Fresenius Kidney Care | Tampa | Florida | 33614 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Michigan Kidney Consultants | Pontiac | Michigan | 48341 | United States |
| DaVita Clinical Research | Roseville | Michigan | 48066 | United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| Fresenius Kidney Care | Brookhaven | Mississippi | 39601 | United States |
| DaVita Clinical Research | Kansas City | Missouri | 64111 | United States |
| DaVita Clinical Research | Las Vegas | Nevada | 89128 | United States |
| Fresenius Kidney Care | Reno | Nevada | 89511 | United States |
| DaVita Clinical Research | The Bronx | New York | 10461 | United States |
| DaVita Clinical Research | Asheville | North Carolina | 28801 | United States |
| Fresenius Kidney Care | Durham | North Carolina | 22704 | United States |
| Piedmont Dialysis Center | Winston-Salem | North Carolina | 27101 | United States |
| Hypertension Nephrology Consultants, Inc | Columbus | Ohio | 43215 | United States |
| Fresenius Kidney Care | Bethlehem | Pennsylvania | 18017 | United States |
| DaVita Clinical Research | Chester | Pennsylvania | 19013 | United States |
| Fresenius Kidney Care | Columbia | South Carolina | 29203 | United States |
| Knoxville Kidney Center | Knoxville | Tennessee | 37923 | United States |
| DaVita Clinical Research | Houston | Texas | 77004 | United States |
| Clinical Advancement Center | San Antonio | Texas | 78212 | United States |
| DaVita Clinical Research | Chesapeake | Virginia | 23320 | United States |
| DaVita Clinical Research | Norfolk | Virginia | 23502 | United States |
| Fresenius Kidney Care | Roanoke | Virginia | 24014 | United States |
| DaVita Clinical Research | Wauwatosa | Wisconsin | 53226 | United States |
| Clinques Universitaries de Bruxelles Hopital | Brussels | Belgium |
| UZ Leuven | Leuven | Belgium |
| AZ Delta | Roeselare | Belgium |
| Nephrologischen Zentrum Villingen-Schwenningen | Villingen-Schwenningen | Baden-Wurttemberg | Germany |
| Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Berlin | Germany |
| DaVita Deutschland AG | Düsseldorf | Germany |
| Centrum Dializ Fresenius, Ośrodek Dializ nr 10 w Bydgoszczy 85-826 | Bydgoszcz | Poland |
| Centrum Dializ Fresenius, Ośrodek Dializ nr 18 w Krakowie.. | Krakow | Poland |
| Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi Stacja Dializ, | Lodz | Poland |
| DaVita Sp. z o.o., Stacja Dializ w Miechowie | Miechów | Poland |
| Centrum Dializ Fresenius Ośrodek Dializ nr 32 w Radomiu 26-617 . | Radom | Poland |
| Fundacio Puigvert | Barcelona | 08025 | Spain |
| University of Barcelona Hospital Clinic | Barcelona | 08036 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Spain |
| Royal Devon and Exeter Hospital (Wonford) | Exeter | Devon | United Kingdom |
| Salford Royal NHS Foundation Trust | Salford | Greater Manchester | M6 8HD | United Kingdom |
| Leicester General Hospital | Leicester | Leicestershire | le5 4pw | United Kingdom |
| Queen Elizabeth University Hospital Campus | Glasgow | Strathclyde | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | West Midlands | United Kingdom |
| Kings College Hospital | London | SE59RS | United Kingdom |
| 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. |
| FG001 | Placebo (Double-blind Period) + SNF472 (Open-label) | Part 1 (double-blind period) Participants received placebo for 12 weeks in addition to their background care. Dose: Matching placebo (saline) diluted in 100 mL physiological saline. Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions fo 12 weeks Part 2 (Open-label): Participants received SNF472 for 12 weeks in addition to their background care. Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 2 |
|
|
Modified Intent-to-treat Population (mITT): The modified mITT population was defined as all enrolled subjects who were randomized, received at least one dose of study drug, and had at least one post-randomization efficacy evaluation.
The mITT population was the primary analysis population for efficacy endpoints.
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| ID | Title | Description |
|---|---|---|
| BG000 | SNF472 | Part 1 (double-blind period): Participants received SNF472 for 12 weeks in addition to their background care. Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks. Part 2 (Open-label): Participants received SNF472 for 12 weeks in addition to their background care. Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks. |
| BG001 | Placebo | Part 1 (double-blind period) Participants received placebo for 12 weeks in addition to their background care. Dose: Matching placebo (saline) diluted in 100 mL physiological saline. Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions fo 12 weeks. Part 2 (Open-label): Participants received SNF472 for 12 weeks in addition to their background care. Dose: 7 mg/kg SNF472 diluted in 100 mL physiological saline. Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Modified Intent-to-treat Population (mITT) population: defined as all enrolled subjects who were randomized, received at least one dose of study drug, and had at least one post-randomization efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | from Baseline to Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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). | Modified Intent-to-treat Population (mITT) population: defined as all enrolled subjects who were randomized, received at least one dose of study drug, and had at least one post-randomization efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | from Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in the Wound-Quality of Life Score | The Wound Quality of Life scale is a validated self-assessment tool that has been shown to be feasible for assessing health-related quality of life in patients with chronic wounds. Lower scores are associated with a better quality of life as reported by the patient. The score is computed by averaging the 17 items on impairments assessed on a scale of 0 to 4 for the preceding 7 days. A global score can only be computed if at least 75% of the items have been answered, i.e., at least 13 in 17 items are valid. All the available items' scores were added up and divided by 17. In case of missing assessments for any one of the 17 items, the median of the scores for a particular item within the associated randomized treatment group was used for the imputation purposes. As the absolute change from baseline is reported, a higher negative value is associated with a higher improvement of quality of life. | Modified Intent-to-treat Population (mITT) population: defined as all enrolled subjects who were randomized, received at least one dose of study drug, and had at least one post-randomization efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | from Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in the BWAT Total Score for the Primary Lesion | The Bates Jensen Wound Assessment Tool (BWAT) score ranges from a minimum score of 9 (best) to a maximum score of 65 (worst) score. | Modified Intent-to-treat Population (mITT) population: defined as all enrolled subjects who were randomized, received at least one dose of study drug, and had at least one post-randomization efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | from Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Qualitative Wound Image Evaluation for the Primary Lesion | A qualitative assessment (Worsened, Equal to, or Improved Relative to Baseline) was assigned | Modified Intent-to-treat Population (mITT) population: defined as all enrolled subjects who were randomized, received at least one dose of study drug, and had at least one post-randomization efficacy evaluation. | Posted | Count of Participants | Participants | at Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Change in Opioid Use as Measured in Morphine Milligram Equivalents (MME) | Change from baseline in opioid use MME = Morphine Milligram Equivalents The calculation of the pre-specified list of opioids was based on the formula: strength per unit × (number of units/days supply) × MME conversion factor = MME/day, as specified in the opioid MME conversion guide (CMS, 2017). The maintenance opioid dose was defined as the average daily opioid dose in MME during the 7-day period prior to Screening Visit 2. To assess the extent to which opioid use may have differed between randomized treatment groups over time, the change from baseline in daily average MME value was analyzed. | Modified Intent-to-treat Population (mITT) population: defined as all enrolled subjects who were randomized, received at least one dose of study drug, and had at least one post-randomization efficacy evaluation. | Posted | Least Squares Mean | Standard Error | MME/week | from Baseline to Week 12 |
|
Part 1: 12-week double-blind, randomized, placebo-controlled treatment period Part 2: 12-week open-label treatment period after completion of part 1 period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SNF472 - Safety Analysis Population (Part 1) | Participants who received SNF472 treatment during part 1 (Double-blind Period). The number of participants in the safety set differs from the previous figures provided in the Participant Flow section, as 1 participant associated to placebo arm, by mistake, actually received a few infusions with SNF472. As a consequence, this participant is counted within the SNF472 Safety Analysis Population (making it 38 subjects instead of 37). | 1 | 38 | 13 | 38 | 27 | 38 |
| EG001 | Placebo - Safety Analysis Population (Part 1) | Participants who received placebo during part 1 (Double-blind Period). | 6 | 33 | 17 | 33 | 21 | 33 |
| EG002 | SNF472 Open Label - Safety Analysis Population (Part 2) | Participants who received SNF472 treatment during part 2 (Open-label) | 1 | 60 | 18 | 60 | 33 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Arteriovenous graft site haemorrhage | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dieulafoy's vascular malformation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arteriovenous fistula site infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Calciphylaxis | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Calciphylaxis | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Hypervolemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vascular access malfunction | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (25.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Szecsödy | Sanifit Therapeutics S. A. | +41588529079 | clinicaltrials@cslbehring.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2023 | Nov 14, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002115 | Calciphylaxis |
| D014947 | Wounds and Injuries |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Other |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| North America |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| OG001 |
| Placebo |
Participants who received placebo for 12 weeks in addition to their background care during the double-blind period (Part 1). Matching placebo (saline) diluted in 100 mL physiological saline. Placebo Comparator: Placebo: Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions fo 12 weeks |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|