Secondary Hyperparathyroidism, Chronic Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, Dialysis, Secondary Hyperparathyroidism, Pediatric
Brief summary
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.
Detailed description
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.
Interventions
DRUGCinacalcet
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.
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
All subjects: * Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any Study 20140159 activities/procedures being initiated. * Dialysate calcium concentration ≥ 2.5 mEq/L at day 1 All subjects with \> 14 days between the last study visit in Study 20130356 or Study 20110100 and screening for Study 20140159: * Subjects on anti-convulsant medication must be on a stable dose All subjects from 20130356: * Completed treatment through week 20 in the 20130356 study or on study at the time of Study 20130356 termination * Dry weight ≥ 12.5 kg at day 1 of Study 20140159 Subjects Randomized to the 20130356 Standard of Care Arm Only: * intact parathyroid hormone (iPTH) value ≥ 300 pg/mL (within 7 days of day 1 in Study 20140159) * Corrected calcium value ≥ 8.8 mg/dL within 7 days of day 1 in Study 20140159 All Subjects from 20110100: * Completed week 26 End of Study visit in the, 20110100 study or on study at the time of Study 20110100 termination * Dry weight ≥ 7 kg at day 1 of Study 20140159
Exclusion criteria
General (studies 20130356 and 20110100): * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s), other than Amgen Studies 20130356 or 20110100. * Other investigational procedures while participating in this study are excluded. * Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. * Subject has known sensitivity to any of the products to be administered during dosing. * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary \[ediary\]) to the best of the subject and investigator's knowledge * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. * Subject previously has entered this study. * If sexually active, subject is not willing to use acceptable contraception during treatment and for at least 9 days after the end of treatment. * Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment * History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias, or other conditions associated with prolonged QT interval * A new onset of seizures or worsening of pre-existing seizure disorder 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks. | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28 | Extension study baseline and 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. |
| Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28 | Extension study baseline and 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. |
| Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28 | 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. |
| Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28 | Extension study baseline and weeks 23 and 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. |
| Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28 | Extension study baseline and weeks 23 and 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. |
| Serum Corrected Calcium at Baseline, Week 11, and Week 28 | Extension study baseline, week 11 and week 28 | Data collected more than 7 days after the last dose of study drug were excluded. |
| Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15 | 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 | 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. |
| Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15 | Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment. | 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. |
| Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28 | Baseline and weeks 23 and 28, relative to day 1 of cinacalcet treatment. | 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. |
| Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | 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). | 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. |
| Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | 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 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. |
| Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | 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 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. |
| Serum Phosphorus at Baseline, Week 11, and Week 28 | Extension study baseline, week 11 and week 28 | Data collected more than 7 days after the last dose of study drug were excluded. |
Countries
Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Russia, Ukraine, United States
Participant flow
Recruitment details
This study was conducted at 16 centers in United States, Russian Federation, Ukraine, Belgium, Czech Republic, Greece, France, and Poland.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 14 |
| 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 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Decision by sponsor | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | 20130356 SOC | 20110100 SOC + Cinacalcet | 20130356 SOC + Cinacalcet |
|---|---|---|---|---|
| Age, Continuous | 14.0 years | 14.0 years | 2.0 years | 14.0 years |
| Age, Customized 12 to ≤ 18 years | 17 Participants | 9 Participants | 0 Participants | 8 Participants |
| Age, Customized 28 days to < 2 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 2 to < 6 years | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Age, Customized 6 to < 12 years | 10 Participants | 4 Participants | 0 Participants | 6 Participants |
| Calcium Phosphorus Product (Ca x P) Day 1 of cinacalcet treatment baseline | 56.81 mg²/dL² | 54.42 mg²/dL² | 98.90 mg²/dL² | 57.98 mg²/dL² |
| Calcium Phosphorus Product (Ca x P) Extension study baseline | 56.71 mg²/dL² | 54.42 mg²/dL² | 82.28 mg²/dL² | 57.80 mg²/dL² |
| Corrected Total Serum Calcium Day 1 of cinacalcet treatment baseline | 9.80 mg/dL | 9.56 mg/dL | 10.90 mg/dL | 9.86 mg/dL |
| Corrected Total Serum Calcium Extension study baseline | 9.80 mg/dL | 9.56 mg/dL | 10.29 mg/dL | 9.93 mg/dL |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 12 Participants | 1 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Intact Parathyroid Hormone (iPTH) Day 1 of cinacalcet treatment baseline | 980.56 pg/mL | 1432.69 pg/mL | 992.60 pg/mL | 798.10 pg/mL |
| Intact Parathyroid Hormone (iPTH) Extension study baseline | 1047.41 pg/mL | 1432.69 pg/mL | 907.74 pg/mL | 1001.35 pg/mL |
| Ionized Calcium Day 1 of cinacalcet treatment baseline | 1.215 mmol/L | 1.130 mmol/L | 1.340 mmol/L | 1.225 mmol/L |
| Ionized Calcium Extension study baseline | 1.140 mmol/L | 1.130 mmol/L | 1.390 mmol/L | 1.145 mmol/L |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black (or African American) | 5 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 12 Participants | 1 Participants | 9 Participants |
| Serum Phosphorus Day 1 of cinacalcet treatment baseline | 5.74 mg/dL | 5.57 mg/dL | 9.00 mg/dL | 5.75 mg/dL |
| Serum Phosphorus Extension study baseline | 5.85 mg/dL | 5.57 mg/dL | 8.08 mg/dL | 6.05 mg/dL |
| Sex: Female, Male Female | 18 Participants | 8 Participants | 0 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 | 1 / 1 | 1 / 28 |
| other Total, other adverse events | 9 / 13 | 10 / 14 | 1 / 1 | 20 / 28 |
| serious Total, serious adverse events | 2 / 13 | 6 / 14 | 1 / 1 | 9 / 28 |
Outcome results
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?
Time frame: From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.
Population: All enrolled participants who received at least one dose of study drug in the extension study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 20130356 SOC | Number of Participants With Adverse Events | Treatment-related AE Grade ≥ 4 | 0 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | AE leading to discontinuation of study drug | 0 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | AE Grade ≥ 3 | 2 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | Treatment-related AE Grade ≥ 3 | 0 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | Fatal adverse events | 0 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | AE Grade ≥ 2 | 2 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | Treatment-related AE Grade ≥ 2 | 0 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | Treatment-related adverse events (TRAE) | 5 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | Treatment-related serious adverse events | 0 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | AE Grade ≥ 4 | 0 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | Fatal treatment-related adverse events | 0 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | Any adverse event (AE) | 9 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | Serious adverse event (SAE) | 2 Participants |
| 20130356 SOC | Number of Participants With Adverse Events | TRAE leading to discontinuation of study drug | 0 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | Treatment-related AE Grade ≥ 4 | 0 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | Any adverse event (AE) | 10 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | AE Grade ≥ 2 | 7 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | AE Grade ≥ 3 | 6 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | AE Grade ≥ 4 | 0 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | Serious adverse event (SAE) | 6 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | AE leading to discontinuation of study drug | 0 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | Fatal adverse events | 0 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | Treatment-related adverse events (TRAE) | 4 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | Treatment-related AE Grade ≥ 2 | 1 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | Treatment-related AE Grade ≥ 3 | 0 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | Treatment-related serious adverse events | 0 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | TRAE leading to discontinuation of study drug | 0 Participants |
| 20130356 SOC + Cinacalcet | Number of Participants With Adverse Events | Fatal treatment-related adverse events | 0 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | TRAE leading to discontinuation of study drug | 0 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | Treatment-related AE Grade ≥ 3 | 0 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | Serious adverse event (SAE) | 1 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | AE Grade ≥ 4 | 1 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | Treatment-related AE Grade ≥ 4 | 0 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | AE Grade ≥ 3 | 1 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | Any adverse event (AE) | 1 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | Treatment-related serious adverse events | 0 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | AE Grade ≥ 2 | 1 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | Treatment-related adverse events (TRAE) | 0 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | Fatal adverse events | 1 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | Fatal treatment-related adverse events | 0 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | Treatment-related AE Grade ≥ 2 | 0 Participants |
| 20110100 SOC + Cinacalcet | Number of Participants With Adverse Events | AE leading to discontinuation of study drug | 0 Participants |
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.
Time frame: Extension study baseline and weeks 23 and 28
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 20130356 SOC | Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28 | -0.24 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28 | -0.24 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28 | -0.74 mg/dL |
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.
Time frame: Extension study baseline and weeks 23 and 28
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 20130356 SOC | Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28 | 0.19 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28 | -0.08 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28 | 0.82 mg/dL |
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.
Time frame: 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).
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 3 | -0.18 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 7 | -0.34 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 11 | -0.35 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 15 | -0.37 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 17 | -0.02 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 19 | -0.43 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 23 | -0.18 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 27 | -0.14 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | End of treatment | 0.18 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | End of study | 1.00 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 39 | -0.63 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | End of treatment | -0.04 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 27 | -0.24 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 3 | 0.19 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 31 | -0.00 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 7 | -0.01 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 35 | -0.42 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 11 | -0.06 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 15 | 0.06 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 43 | -0.37 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 17 | -0.11 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 18 | -0.17 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 48 | -0.55 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 19 | -0.20 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 20 | -0.01 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 21 | -0.36 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 52 | -0.16 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 23 | -0.20 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 15 | 0.5 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 19 | -0.1 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 11 | -0.5 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 17 | -0.8 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 3 | -0.1 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 18 | -0.3 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 21 | -2.6 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time | Week 7 | -0.5 mg/dL |
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.
Time frame: 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).
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | End of study | 1.20 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 3 | -0.24 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 7 | -0.16 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 11 | 0.01 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 15 | -0.52 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 17 | -0.08 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 19 | -0.45 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 23 | -0.37 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 27 | -0.18 mg/dL |
| 20130356 SOC | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | End of treatment | -0.18 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 18 | 0.61 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 31 | 0.83 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 7 | 0.37 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 15 | 0.96 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 35 | -0.03 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 11 | 1.17 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 43 | 0.33 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 52 | 0.61 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 19 | 0.91 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 48 | 0.60 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 20 | 0.84 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 21 | 0.17 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 17 | 1.57 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 39 | 0.40 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 23 | 0.55 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | End of treatment | 0.43 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 27 | 0.76 mg/dL |
| 20130356 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 3 | 0.81 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 11 | 0 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 15 | -1.9 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 18 | -0.9 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 19 | -0.3 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 21 | 0.1 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 3 | 5.6 mg/dL |
| 20110100 SOC + Cinacalcet | Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time | Week 7 | 0.3 mg/dL |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 20130356 SOC | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15 | 30.8 percentage of participants |
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.
Time frame: Extension study baseline and weeks 23 and 28
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 20130356 SOC | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28 | 23.1 percentage of participants |
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.
Time frame: Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 20130356 SOC | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15 | 30.8 percentage of participants |
| 20130356 SOC + Cinacalcet | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15 | 35.7 percentage of participants |
| 20110100 SOC + Cinacalcet | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15 | 100.0 percentage of participants |
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.
Time frame: Baseline and weeks 23 and 28, relative to day 1 of cinacalcet treatment.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 20130356 SOC | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28 | 23.1 percentage of participants |
| 20130356 SOC + Cinacalcet | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28 | 35.7 percentage of participants |
| 20110100 SOC + Cinacalcet | Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28 | 0.0 percentage of participants |
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.
Time frame: Weeks 23 and 28
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 20130356 SOC | Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28 | 7.7 percentage of participants |
| 20130356 SOC + Cinacalcet | Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28 | 21.4 percentage of participants |
| 20110100 SOC + Cinacalcet | Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28 | 0.0 percentage of participants |
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.
Time frame: Extension study baseline and weeks 23 and 28
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 20130356 SOC | Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28 | 11.43 percent change |
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.
Time frame: 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).
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 20130356 SOC | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 17 | -23.93 percent change |
| 20130356 SOC | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | End of study | 105.27 percent change |
| 20130356 SOC | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 23 | -9.05 percent change |
| 20130356 SOC | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 11 | 19.75 percent change |
| 20130356 SOC | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 20 | -13.12 percent change |
| 20130356 SOC | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 19 | -37.17 percent change |
| 20130356 SOC | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 7 | 1.99 percent change |
| 20130356 SOC | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | End of treatment | -8.50 percent change |
| 20130356 SOC | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 15 | -7.67 percent change |
| 20130356 SOC | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 3 | 10.16 percent change |
| 20130356 SOC | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 27 | -8.50 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 3 | -6.88 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 7 | -4.96 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 11 | -7.64 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 15 | -13.04 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 17 | -3.09 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 18 | -29.85 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 19 | -3.50 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 39 | 0.09 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 43 | -17.13 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 48 | -45.67 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 52 | 86.50 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | End of treatment | -45.67 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | End of study | 20.21 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 31 | 32.30 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 20 | 0.44 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 23 | -6.65 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 27 | 16.36 percent change |
| 20130356 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 35 | 16.82 percent change |
| 20110100 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 18 | -7.49 percent change |
| 20110100 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 3 | 55.54 percent change |
| 20110100 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 20 | 160.80 percent change |
| 20110100 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 17 | -20.02 percent change |
| 20110100 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 7 | 9.78 percent change |
| 20110100 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 15 | -73.85 percent change |
| 20110100 SOC + Cinacalcet | Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time | Week 11 | -7.00 percent change |
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.
Time frame: Extension study baseline, week 11 and week 28
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 20130356 SOC | Serum Corrected Calcium at Baseline, Week 11, and Week 28 | Week 11 | 9.35 mg/dL |
| 20130356 SOC | Serum Corrected Calcium at Baseline, Week 11, and Week 28 | Extension study baseline | 9.56 mg/dL |
| 20130356 SOC | Serum Corrected Calcium at Baseline, Week 11, and Week 28 | Week 28 | 9.50 mg/dL |
| 20130356 SOC + Cinacalcet | Serum Corrected Calcium at Baseline, Week 11, and Week 28 | Week 28 | 9.90 mg/dL |
| 20130356 SOC + Cinacalcet | Serum Corrected Calcium at Baseline, Week 11, and Week 28 | Week 11 | 9.85 mg/dL |
| 20130356 SOC + Cinacalcet | Serum Corrected Calcium at Baseline, Week 11, and Week 28 | Extension study baseline | 9.93 mg/dL |
| 20110100 SOC + Cinacalcet | Serum Corrected Calcium at Baseline, Week 11, and Week 28 | Extension study baseline | 10.29 mg/dL |
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.
Time frame: Extension study baseline, week 11 and week 28
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 20130356 SOC | Serum Phosphorus at Baseline, Week 11, and Week 28 | Week 11 | 5.25 mg/dl |
| 20130356 SOC | Serum Phosphorus at Baseline, Week 11, and Week 28 | Extension study baseline | 5.57 mg/dl |
| 20130356 SOC | Serum Phosphorus at Baseline, Week 11, and Week 28 | Week 28 | 5.00 mg/dl |
| 20130356 SOC + Cinacalcet | Serum Phosphorus at Baseline, Week 11, and Week 28 | Week 28 | 5.95 mg/dl |
| 20130356 SOC + Cinacalcet | Serum Phosphorus at Baseline, Week 11, and Week 28 | Week 11 | 6.20 mg/dl |
| 20130356 SOC + Cinacalcet | Serum Phosphorus at Baseline, Week 11, and Week 28 | Extension study baseline | 6.05 mg/dl |
| 20110100 SOC + Cinacalcet | Serum Phosphorus at Baseline, Week 11, and Week 28 | Extension study baseline | 8.08 mg/dl |