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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003563-38 | EudraCT Number |
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The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.
This extension study was designed to characterize the long-term safety and tolerability of cinacalcet in pediatric patients from Amgen Studies 20130356 (NCT02138838) and 20110100 (NCT01439867) who either had completed the parent study or were ongoing at the time an administrative decision was made to end the parent study. After enrolling into this study participants were administered cinacalcet for 28 weeks or until the time of renal transplant or parathyroidectomy, whichever occurred first. The treatment period was followed by a 4-week safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cinacalcet | Experimental | Participants received cinacalcet daily for 24 weeks in this extension study. For participants who received standard of care (SOC) in parent study 20130356, the starting dose was 0.20 mg/kg/day. For participants who received SOC and cinacalcet in parent study 20130356 or 20110100 the starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinacalcet | Drug | Cinacalcet was provided as 5 mg capsules for sprinkling or as 30 mg film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a "yes" or "no" response to the question: Is there a reasonable possibility that the event may have been caused by the study drug? | From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15 | This endpoint was analyzed in participants who received SOC only in parent study 20130356. Participants who had no iPTH values during weeks 11 or 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded. | Baseline (defined as the mean values of samples collected during the screening period and day 1 pre-dose in the extension study) and weeks 11 and 15 |
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INCLUSION CRITERIA:
All subjects:
All subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and screening for Study 20140159:
All subjects from 20130356:
Subjects Randomized to the 20130356 Standard of Care Arm Only:
All Subjects from 20110100:
EXCLUSION CRITERIA:
General (studies 20130356 and 20110100):
All Subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and the screening visit in Study 20140159 will have the following exclusion criteria applied during screening and day 1:
All Subjects - Day 1 Study Visit:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | 90027 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32367309 | Background | Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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This extension study enrolled participants who completed one of the parent studies 20110100 (NCT01439867) or 20130356 (NCT02138838). Results are reported by treatment received in the parent study.
This study was conducted at 16 centers in United States, Russian Federation, Ukraine, Belgium, Czech Republic, Greece, France, and Poland.
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| ID | Title | Description |
|---|---|---|
| FG000 | 20130356 SOC | Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 21, 2017 | Mar 7, 2018 |
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| Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28 | This endpoint was analyzed in participants who received SOC only in parent study 20130356. For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded. | Extension study baseline and weeks 23 and 28 |
| Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28 | This endpoint was analyzed in participants who received SOC only in parent study 20130356. For participants who had no values during week 23 and week 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded. | Extension study baseline and weeks 23 and 28 |
| Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28 | For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded. | Weeks 23 and 28 |
| Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28 | For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded. | Extension study baseline and weeks 23 and 28 |
| Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28 | For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded. | Extension study baseline and weeks 23 and 28 |
| Serum Corrected Calcium at Baseline, Week 11, and Week 28 | Data collected more than 7 days after the last dose of study drug were excluded. | Extension study baseline, week 11 and week 28 |
| Serum Phosphorus at Baseline, Week 11, and Week 28 | Data collected more than 7 days after the last dose of study drug were excluded. | Extension study baseline, week 11 and week 28 |
| Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15 | The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356. Participants who had no iPTH values during weeks 11 and 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded. | Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment. |
| Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28 | The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356. For participants who did not have an iPTH value during weeks 23 and 28, the mean of the last two available post-baseline values collected at protocol-specified visits was used. If only one post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded. | Baseline and weeks 23 and 28, relative to day 1 of cinacalcet treatment. |
| Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Percent change in iPTH measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded. | Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit). |
| Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Change in corrected calcium measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded. | Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit). |
| Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Change in phosphorus measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded. | Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit). |
| Tucker |
| Georgia |
| 30084 |
| United States |
| Research Site | Baltimore | Maryland | 21287 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | Minneapolis | Minnesota | 55454 | United States |
| Research Site | Jackson | Mississippi | 39216 | United States |
| Research Site | Kansas City | Missouri | 64108 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | West Orange | New Jersey | 07052 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | Greenville | North Carolina | 27834 | United States |
| Research Site | Cincinnati | Ohio | 45229 | United States |
| Research Site | Cleveland | Ohio | 44195 | United States |
| Research Site | Columbus | Ohio | 43205 | United States |
| Research Site | Oklahoma City | Oklahoma | 73104 | United States |
| Research Site | Dallas | Texas | 75235 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Salt Lake City | Utah | 84113 | United States |
| Research Site | Brussels | 1020 | Belgium |
| Research Site | Prague | 150 06 | Czechia |
| Research Site | Paris | 75015 | France |
| Research Site | Hanover | 30625 | Germany |
| Research Site | Heidelberg | 69120 | Germany |
| Research Site | Marburg | 35043 | Germany |
| Research Site | Athens | 11527 | Greece |
| Research Site | Szeged | 6720 | Hungary |
| Research Site | Genova | 16147 | Italy |
| Research Site | Krakow | 30-663 | Poland |
| Research Site | Lodz | 93-338 | Poland |
| Research Site | Moscow | 107014 | Russia |
| Research Site | Saint Petersburg | 198205 | Russia |
| Research Site | Samara | 443095 | Russia |
| Research Site | Kyiv | 01135 | Ukraine |
| FG001 | 20130356 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
| FG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 20130356 SOC | Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
| BG001 | 20130356 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
| BG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
| BG003 | 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, Continuous | Median | Full Range | years |
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| Age, Customized | One participants in the 20130356 SOC group was 17 years old at the time of enrollment of parent study and had turned 18 at the time of enrollment of Study 20140159. | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Intact Parathyroid Hormone (iPTH) | Intact parathyroid hormone levels are reported for the extension study baseline and also for baseline relative to day 1 of cinacalcet treatment (equivalent to baseline of extension study for participants who received SOC alone in parent study 20130356; transferred from parent study for all other participants). | Median | Inter-Quartile Range | pg/mL |
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| Corrected Total Serum Calcium | Total serum calcium was corrected using the following formula if the serum albumin was < 4 g/dL: Corrected total serum calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 - serum albumin (g/dL)) Corrected calcium levels are reported for the extension study baseline and also for baseline relative to day 1 of cinacalcet treatment (equivalent to baseline of extension study for participants who received SOC alone in parent study 20130356; transferred from parent study for all other participants). | Median | Inter-Quartile Range | mg/dL |
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| Ionized Calcium | Median | Inter-Quartile Range | mmol/L |
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| Serum Phosphorus | Phosphorus levels are reported for the extension study baseline and also for baseline relative to day 1 of cinacalcet treatment (equivalent to baseline of extension study for participants who received SOC alone in parent study 20130356; transferred from parent study for all other participants). | Median | Inter-Quartile Range | mg/dL |
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| Calcium Phosphorus Product (Ca x P) | Median | Inter-Quartile Range | mg²/dL² |
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| 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 | Number of Participants With Adverse Events | Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a "yes" or "no" response to the question: Is there a reasonable possibility that the event may have been caused by the study drug? | All enrolled participants who received at least one dose of study drug in the extension study. | Posted | Count of Participants | Participants | From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks. |
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| Secondary | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15 | This endpoint was analyzed in participants who received SOC only in parent study 20130356. Participants who had no iPTH values during weeks 11 or 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded. | Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (defined as the mean values of samples collected during the screening period and day 1 pre-dose in the extension study) and weeks 11 and 15 |
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| Secondary | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28 | This endpoint was analyzed in participants who received SOC only in parent study 20130356. For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded. | Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study. | Posted | Number | 95% Confidence Interval | percentage of participants | Extension study baseline and weeks 23 and 28 |
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| Secondary | Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28 | This endpoint was analyzed in participants who received SOC only in parent study 20130356. For participants who had no values during week 23 and week 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded. | Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study. | Posted | Median | Inter-Quartile Range | percent change | Extension study baseline and weeks 23 and 28 |
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| Secondary | Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28 | For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded. | All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 23 and 28 |
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| Secondary | Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28 | For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded. | All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study. | Posted | Median | Inter-Quartile Range | mg/dL | Extension study baseline and weeks 23 and 28 |
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| Secondary | Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28 | For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded. | All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study. | Posted | Median | Inter-Quartile Range | mg/dL | Extension study baseline and weeks 23 and 28 |
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| Secondary | Serum Corrected Calcium at Baseline, Week 11, and Week 28 | Data collected more than 7 days after the last dose of study drug were excluded. | All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point. | Posted | Median | Inter-Quartile Range | mg/dL | Extension study baseline, week 11 and week 28 |
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| Secondary | Serum Phosphorus at Baseline, Week 11, and Week 28 | Data collected more than 7 days after the last dose of study drug were excluded. | All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point. | Posted | Median | Inter-Quartile Range | mg/dl | Extension study baseline, week 11 and week 28 |
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| Secondary | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15 | The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356. Participants who had no iPTH values during weeks 11 and 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded. | All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment. |
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| Secondary | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28 | The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356. For participants who did not have an iPTH value during weeks 23 and 28, the mean of the last two available post-baseline values collected at protocol-specified visits was used. If only one post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded. | All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and weeks 23 and 28, relative to day 1 of cinacalcet treatment. |
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| Secondary | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Percent change in iPTH measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded. | All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point. | Posted | Median | Inter-Quartile Range | percent change | Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit). |
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| Secondary | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Change in corrected calcium measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded. | All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point. | Posted | Median | Inter-Quartile Range | mg/dL | Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit). |
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| Secondary | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Change in phosphorus measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded. | All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point. | Posted | Median | Inter-Quartile Range | mg/dL | Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit). |
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From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 20130356 SOC | Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. | 0 | 13 | 2 | 13 | 9 | 13 |
| EG001 | 20130356 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. | 0 | 14 | 6 | 14 | 10 | 14 |
| EG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. | 1 | 1 | 1 | 1 | 1 | 1 |
| EG003 | Total | All participants who received cinacalcet in study 20140159. | 1 | 28 | 9 | 28 | 20 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pericarditis infective | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Device damage | Product Issues | MedDRA 19.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 19.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Catheter placement | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
| |
| Venous occlusion | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Duodenogastric reflux | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Mass | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Adjusted calcium decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood parathyroid hormone decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Red blood cell sedimentation rate increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Staring | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary calcification | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Catheter placement | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Venous haemorrhage | Vascular disorders | MedDRA 19.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2017 | Mar 7, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| 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 |
|---|---|
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| 2 to < 6 years |
|
| 6 to < 12 years |
|
| 12 to ≤ 18 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black (or African American) |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Day 1 of cinacalcet treatment baseline |
|
| Day 1 of cinacalcet treatment baseline |
|
| Day 1 of cinacalcet treatment baseline |
|
| Day 1 of cinacalcet treatment baseline |
|
| Day 1 of cinacalcet treatment baseline |
|
| Title | Measurements |
|---|---|
|
| AE Grade ≥ 3 |
|
| AE Grade ≥ 4 |
|
| Serious adverse event (SAE) |
|
| AE leading to discontinuation of study drug |
|
| Fatal adverse events |
|
| Treatment-related adverse events (TRAE) |
|
| Treatment-related AE Grade ≥ 2 |
|
| Treatment-related AE Grade ≥ 3 |
|
| Treatment-related AE Grade ≥ 4 |
|
| Treatment-related serious adverse events |
|
| TRAE leading to discontinuation of study drug |
|
| Fatal treatment-related adverse events |
|
|
|
|
|
| OG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
|
|
| OG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
|
|
| OG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
|
|
| OG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
|
|
| OG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
|
|
| OG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
|
|
| OG001 |
| 20130356 SOC + Cinacalcet |
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
| OG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
|
|
| OG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
|
|
| OG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
|
|
| OG002 | 20110100 SOC + Cinacalcet | Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
|
|