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This was a multiple-dose, double-blind, randomized, placebo-controlled study. Chinese subjects residing in Mainland China with chronic kidney disease (CKD) receiving hemodialysis were randomized in a 3:1 ratio to receive 5 mg intravenous (IV) of etelcalcetide or placebo 3 times a week (TIW) for approximately 4 weeks, with a subsequent follow up period of approximately 4 weeks.
Doses were given at the end of each scheduled hemodialysis session on study days 1 through day 27 and subject participation was complete after day 55 end-of-study (EOS) procedures were performed. Doses were administered TIW for 4 weeks, for a total of 12 doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Intravenous (IV) administration of placebo three times a week (TIW) for 4 weeks for a total of 12 doses. Participants were followed for an additional 4 weeks. |
|
| Etelcalcetide | Experimental | 5 mg intravenous (IV) dose of etelcalcetide three times a week (TIW) for 4 weeks for a total of 12 doses. Participants were followed for an additional 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etelcalcetide | Drug | Etelcalcetide was supplied as a sterile, preservative-free, aqueous solution in a single-use 3 mL glass vial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Time to Maximum Drug Concentration (Tmax) of Plasma Etelcalcetide on Days 1 and 27 | Tmax is the time to maximum drug concentration of plasma etelcalcetide after dosing on Days 1 and 27. | Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration |
| PK: Maximum Observed Drug Concentration (Cmax) of Plasma Etelcalcetide on Days 1 and 27 | Cmax was defined as the maximum observed plasma drug concentration measured between the time of drug administration to the beginning of the next dialysis session. | Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration |
| Pharmacokinetic (PK) Parameter: Area Under the Curve From Time Zero to the Beginning of the Subsequent Hemodialysis Treatment (AUClast) of Plasma Etelcalcetide on Days 1 and 27 | AUClast was specifically defined in this study as the area under the concentration time curve measured from the time of drug administration to the beginning of the next dialysis session, following the first and last dose. | Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29 |
| Pharmacokinetic (PK) Parameter: Accumulation Ratio Comparing Days 1 and 27 | Accumulation ratio, calculated as AUClast day 27/AUClast day 1. | Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Treatment-Emergent Adverse Events (TEAEs) | The severity of each adverse event was assessed using the NCI-CTCAE Version 4.0 according to the following:
A serious AE is an AE that met one or more of the following criteria:
|
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Inclusion Criteria:
Exclusion Criteria:
Corrected calcium (calculated) level is < 2.07 mmol/L (8.3 mg/dL), and/or intact PTH level is outside the range of 31.8 - 127.3 pmol/L (300 - 1200 pg/mL)
Female subjects who are pregnant, lactating/breastfeeding, or who plan to conceive, or breastfeed while on study through 3 months after receiving the dose of study drug
Female subject of reproductive potential not willing to use a(n) acceptable method(s) of effective birth control during treatment with AMG 416, and for an additional 3 months after the end of treatment with AMG 416. Female subjects who have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal ligation, or who are postmenopausal are not required to use contraception. Postmenopausal is defined as:
Females of reproductive potential with a positive pregnancy test, unless medical follow-up confirms the subject is not pregnant
Previous administration of AMG 416
Subject has received cinacalcet within the 30 days prior to informed consent (treatment with cinacalcet is prohibited during the study)
Subject has lost 500 mL or more of blood or plasma within 8 weeks of study drug administration or during the study period
Anticipated or scheduled to have major surgical procedures during the study period such as kidney transplant or parathyroidectomy
History of malignancy within 5 years before Day -2 (except non melanoma skin cancers, or cervical carcinoma in situ)
Subject's 12-lead electrocardiogram (ECG) at screening suggests unstable arrhythmia or other cardiac abnormality that could place the subject at increased risk, based upon the Investigator's opinion
Subject has current or history of cardiovascular conditions such as uncontrolled hypertension, symptomatic ventricular dysrhythmias, Torsades de Pointes, angina pectoris congestive heart failure (New York Heart Association Classification III or IV), myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | Beijing Municipality | 100044 | China | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34774334 | Derived | Xing C, Chen J, Zuo L, Fang Y, Ding X, Ni Z, Kong C, Shi G, Lu H, Hellawell J, Cheng S, Sohn W. A Phase I, Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Etelcalcetide Administered Intravenously to Chinese Patients With Chronic Kidney Disease Undergoing Hemodialysis. Clin Ther. 2021 Nov;43(11):2013-2023. doi: 10.1016/j.clinthera.2021.09.019. Epub 2021 Nov 11. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Of the 37 subjects screened, 33 participants were randomized in a 3:1 ratio to either etelcalcetide or placebo in a double-blind manner prior to the Day 1 activities.
This study was conducted at 5 centers in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Intravenous (IV) administration of placebo three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27) . Participants were followed for an additional 4 weeks. |
| FG001 | Etelcalcetide | 5 mg intravenous (IV) dose of etelcalcetide three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27). Participants were followed for an additional 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set consisting of all participants who received at least 1 dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Intravenous (IV) administration of placebo three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27) . Participants were followed for an additional 4 weeks. |
| BG001 | Etelcalcetide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pharmacokinetic (PK) Parameter: Time to Maximum Drug Concentration (Tmax) of Plasma Etelcalcetide on Days 1 and 27 | Tmax is the time to maximum drug concentration of plasma etelcalcetide after dosing on Days 1 and 27. | Pharmacokinetic Concentration Analysis Set: all participants who received at least 1 dose of etelcalcetide and had at least 1 pharmacokinetic sample collected. | Posted | Median | Full Range | hour | Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration |
|
Day 1 up to Day 55 (end of study)
Treatment-emergent adverse events - any adverse events started on or after the first dose of investigational product (IP) up to the end of study date (Day 55).
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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 | Placebo | Intravenous (IV) administration of placebo three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27) . Participants were followed for an additional 4 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2018 | Jan 29, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 25, 2018 | Jan 29, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| C583569 | etelcalcetide hydrochloride |
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This is a multiple dose, double-blind, randomized, placebo-controlled clinical study conducted in Chinese subjects residing in Mainland China with chronic kidney disease receiving hemodialysis. The treatment duration will be approximately 4 weeks with a post treatment followup of 4 weeks. A dose will be given at each scheduled hemodialysis session (Dose administered three times a week for 4 weeks, for a total of 12 doses).
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| Placebo | Drug | Placebo supplied to match active intervention. |
|
| Day 1 up to Day 55 (end of study) |
| Participants With Treatment-Emergent Adverse Events (TEAEs) of Interest | Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. Narrow search criteria used for both standardized MedDRA queries (SMQ) and events of interest (EOI). One preferred term (PT) could match multiple EOIs. Infusion Reaction EOI counts included only those events which had onset day coinciding with study medication infusion and resolved on the same day or the day after onset. | Day 1 up to Day 55 (end of study) |
| Participants With Clinically-Significant Changes in Electrocardiograms (ECGs) From Baseline to End of Study | Count of participants who exhibited a clinically significant change in the results of their 12-lead electrocardiograms (ECG) when comparing baseline to end of study ECGs. | Baseline is Day -2; End of Study is Day 55 |
| Change From Baseline to End of Study in Weight | Change from baseline in weight measured at visit. | Day 1 up to Day 55 |
| Change From Baseline to End of Study in Systolic and Diastolic Blood Pressures | Participants remained seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure. | Baseline Day 1 prior to dialysis; End of Study is Day 55 |
| Baseline and Change From Baseline to End of Study in Heart Rate | Participants remained seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure. | Baseline Day 1 prior to dialysis; End of Study is Day 55 |
| Change From Baseline to End of Study in Calcium | Calcium was tested at a central laboratory. | Baseline is Day 1 prior to dialysis; End of Study is Day 55 |
| Change From Baseline to End of Study in Corrected Calcium (cCa) | Total serum calcium was corrected if the serum albumin was < 4 g/dL or 40 g/L, otherwise cCa equals total serum calcium. The correction formula was: Corrected calcium (mg/dL) = Total calcium (mg/dL) + (4 - albumin [g/dL]) * 0.8 | Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55 |
| Participants With Low Corrected Calcium (cCA) By Category | The lowest cCA value for each participant is reported. Total serum calcium was corrected if the serum albumin was < 4 g/dL or 40 g/L, otherwise cCa equals total serum calcium. The correction formula was: Corrected calcium (mg/dL) = Total calcium (mg/dL) + (4 - albumin [g/dL]) * 0.8 | Timeframes: Days 8, 15, 22, 27, 29, 34, 41, 55 |
| Baseline and Change From Baseline to End of Study in Serum Albumin | Serum albumin was tested at a central laboratory. | Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55 |
| Change From Baseline to End of Study in Serum Phosphorus | Serum phosphorus was tested at a central laboratory. | Baseline is Day 1 prior to dialysis; End of Study is Day 55 |
| Participants With Anti-etelcalcetide Antibody at Baseline and Postbaseline | Participants with positive titers for antibodies to etelcalcetide could be asked to return to the clinical research unit to provide additional serum samples. | Baseline: Day 1 prior to dialysis. Postbaseline: Days 29 and 55 prior to dialysis |
| Nanjing |
| Jiangsu |
| 210029 |
| China |
| Research Site | Shanghai | Shanghai Municipality | 200032 | China |
| Research Site | Shanghai | Shanghai Municipality | 200040 | China |
| Research Site | Shanghai | Shanghai Municipality | 200127 | China |
5 mg intravenous (IV) dose of etelcalcetide three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27). Participants were followed for an additional 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | BMI equals a person's weight in kilograms divided by baseline height in meters squared (kg/m^2). | Mean | Standard Deviation | kg/m^2 |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Intact Parathyroid Hormone (iPTH) | Mean | Standard Deviation | pmol/L |
|
| Corrected Calcium | Mean | Standard Deviation | mmol/L |
|
| Calcium | Mean | Standard Deviation | mmol/L |
|
| Phosphorus | Mean | Standard Deviation | mmol/L |
|
| Potassium | Mean | Standard Deviation | mmol/L |
|
| OG001 | Etelcalcetide | 5 mg intravenous (IV) dose of etelcalcetide three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27). Participants were followed for an additional 4 weeks. |
|
|
| Primary | PK: Maximum Observed Drug Concentration (Cmax) of Plasma Etelcalcetide on Days 1 and 27 | Cmax was defined as the maximum observed plasma drug concentration measured between the time of drug administration to the beginning of the next dialysis session. | Pharmacokinetic concentration analysis set | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration |
|
|
|
| Primary | Pharmacokinetic (PK) Parameter: Area Under the Curve From Time Zero to the Beginning of the Subsequent Hemodialysis Treatment (AUClast) of Plasma Etelcalcetide on Days 1 and 27 | AUClast was specifically defined in this study as the area under the concentration time curve measured from the time of drug administration to the beginning of the next dialysis session, following the first and last dose. | Pharmacokinetic concentration analysis set | Posted | Mean | Standard Deviation | hour*ng/mL | Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29 |
|
|
|
| Primary | Pharmacokinetic (PK) Parameter: Accumulation Ratio Comparing Days 1 and 27 | Accumulation ratio, calculated as AUClast day 27/AUClast day 1. | Pharmacokinetic concentration analysis set | Posted | Mean | Standard Deviation | ratio | Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29 |
|
|
|
| Secondary | Participants With Treatment-Emergent Adverse Events (TEAEs) | The severity of each adverse event was assessed using the NCI-CTCAE Version 4.0 according to the following:
A serious AE is an AE that met one or more of the following criteria:
| Safety Analysis set containing all participants who received at least 1 dose of investigational product (IP) | Posted | Count of Participants | Participants | Day 1 up to Day 55 (end of study) |
|
|
|
| Secondary | Participants With Treatment-Emergent Adverse Events (TEAEs) of Interest | Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. Narrow search criteria used for both standardized MedDRA queries (SMQ) and events of interest (EOI). One preferred term (PT) could match multiple EOIs. Infusion Reaction EOI counts included only those events which had onset day coinciding with study medication infusion and resolved on the same day or the day after onset. | Safety Analysis Set | Posted | Count of Participants | Participants | Day 1 up to Day 55 (end of study) |
|
|
|
| Secondary | Participants With Clinically-Significant Changes in Electrocardiograms (ECGs) From Baseline to End of Study | Count of participants who exhibited a clinically significant change in the results of their 12-lead electrocardiograms (ECG) when comparing baseline to end of study ECGs. | Safety Analysis set of participants with both a baseline and end of study ECG. | Posted | Count of Participants | Participants | Baseline is Day -2; End of Study is Day 55 |
|
|
|
| Secondary | Change From Baseline to End of Study in Weight | Change from baseline in weight measured at visit. | Safety Analysis set | Posted | Mean | Standard Deviation | kg | Day 1 up to Day 55 |
|
|
|
| Secondary | Change From Baseline to End of Study in Systolic and Diastolic Blood Pressures | Participants remained seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure. | Safety Analysis set | Posted | Mean | Standard Deviation | mmHg | Baseline Day 1 prior to dialysis; End of Study is Day 55 |
|
|
|
| Secondary | Baseline and Change From Baseline to End of Study in Heart Rate | Participants remained seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure. | Safety Analysis set | Posted | Mean | Standard Deviation | beats/minute | Baseline Day 1 prior to dialysis; End of Study is Day 55 |
|
|
|
| Secondary | Change From Baseline to End of Study in Calcium | Calcium was tested at a central laboratory. | Safety Analysis set | Posted | Mean | Standard Deviation | mmol/L | Baseline is Day 1 prior to dialysis; End of Study is Day 55 |
|
|
|
| Secondary | Change From Baseline to End of Study in Corrected Calcium (cCa) | Total serum calcium was corrected if the serum albumin was < 4 g/dL or 40 g/L, otherwise cCa equals total serum calcium. The correction formula was: Corrected calcium (mg/dL) = Total calcium (mg/dL) + (4 - albumin [g/dL]) * 0.8 | Safety Analysis set | Posted | Mean | Standard Deviation | mmol/L | Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55 |
|
|
|
| Secondary | Participants With Low Corrected Calcium (cCA) By Category | The lowest cCA value for each participant is reported. Total serum calcium was corrected if the serum albumin was < 4 g/dL or 40 g/L, otherwise cCa equals total serum calcium. The correction formula was: Corrected calcium (mg/dL) = Total calcium (mg/dL) + (4 - albumin [g/dL]) * 0.8 | Safety Analysis set | Posted | Count of Participants | Participants | Timeframes: Days 8, 15, 22, 27, 29, 34, 41, 55 |
|
|
|
| Secondary | Baseline and Change From Baseline to End of Study in Serum Albumin | Serum albumin was tested at a central laboratory. | Safety Analysis set | Posted | Mean | Standard Deviation | g/dL | Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55 |
|
|
|
| Secondary | Change From Baseline to End of Study in Serum Phosphorus | Serum phosphorus was tested at a central laboratory. | Safety Analysis set | Posted | Mean | Standard Deviation | mmol/L | Baseline is Day 1 prior to dialysis; End of Study is Day 55 |
|
|
|
| Secondary | Participants With Anti-etelcalcetide Antibody at Baseline and Postbaseline | Participants with positive titers for antibodies to etelcalcetide could be asked to return to the clinical research unit to provide additional serum samples. | Safety Analysis set | Posted | Count of Participants | Participants | Baseline: Day 1 prior to dialysis. Postbaseline: Days 29 and 55 prior to dialysis |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 7 |
| 8 |
| EG001 | Etelcalcetide | 5 mg intravenous (IV) dose of etelcalcetide three times a week (TIW) administered at the end of dialysis for 4 weeks for a total of 12 doses (on Study Days 1, 3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27). Participants were followed for an additional 4 weeks. | 0 | 25 | 3 | 25 | 22 | 25 |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| 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 |
| Day 27 |
|
|
| Day 27 |
|
|
| TEAEs Grade >= 4 |
|
| Serious TEAEs |
|
| TEAEs leading to study treatment discontinuation |
|
| Fatal TEAEs |
|
| Treatment-related TEAEs |
|
| Treatment-related TEAEs Grade >= 3 |
|
| Treatment-related TEAEs Grade >= 4 |
|
| Treatment-related serious TEAEs |
|
| Trt-related TEAEs leading to study trt discon |
|
| Treatment-related Fatal TEAEs |
|
| Convulsions (SMQ) |
|
| Fractures (EOI) |
|
| Hypersensitivity (SMQ) |
|
| Dermatitis allergic (PT) |
|
| Rash (PT) |
|
| Dermatitis (PT) |
|
| Hypocalcemia (EOI) |
|
| Blood calcium decreased (PT) |
|
| Hypocalcaemia (PT) |
|
| Hypophosphatemia (EOI) |
|
| Infusion reaction (EOI) |
|
| Hypotension (PT) |
|
| Torsade de pointes-QT prolongation (SMQ) |
|
| Ventricular tachyarrhythmias (SMQ) |
|
| No Change in Baseline to End of Study |
|
| Diastolic Blood Pressure |
|
|
| Change from Baseline to End of Study |
|
|
| Participants with cCA 1.87 to < 2.07 mmol/L |
|
| Change from Baseline to End of Study |
|
|
| Title | Measurements |
|---|---|
|