Trial Outcomes & Findings for Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis (NCT NCT02341417)

Last Updated: 2020-06-29

Results Overview

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?

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

28 participants

Primary outcome timeframe

From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.

Results posted on

2020-06-29

Participant Flow

This study was conducted at 16 centers in United States, Russian Federation, Ukraine, Belgium, Czech Republic, Greece, France, and Poland.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	13	14	1
Overall Study COMPLETED	11	12	0
Overall Study NOT COMPLETED	2	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Withdrawal by Subject	0	2	0
Overall Study Decision by sponsor	2	0	0
Overall Study Death	0	0	1

Baseline Characteristics

Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.	Total n=28 Participants Total of all reporting groups
Age, Continuous	14.0 years n=5 Participants	14.0 years n=7 Participants	2.0 years n=5 Participants	14.0 years n=4 Participants
Age, Customized 28 days to < 2 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized 2 to < 6 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Customized 6 to < 12 years	4 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Age, Customized 12 to ≤ 18 years	9 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	0 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	14 Participants n=7 Participants	1 Participants n=5 Participants	27 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Black (or African American)	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	9 Participants n=7 Participants	1 Participants n=5 Participants	22 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Intact Parathyroid Hormone (iPTH) Extension study baseline	1432.69 pg/mL n=5 Participants	1001.35 pg/mL n=7 Participants	907.74 pg/mL n=5 Participants	1047.41 pg/mL n=4 Participants
Intact Parathyroid Hormone (iPTH) Day 1 of cinacalcet treatment baseline	1432.69 pg/mL n=5 Participants	798.10 pg/mL n=7 Participants	992.60 pg/mL n=5 Participants	980.56 pg/mL n=4 Participants
Corrected Total Serum Calcium Extension study baseline	9.56 mg/dL n=5 Participants	9.93 mg/dL n=7 Participants	10.29 mg/dL n=5 Participants	9.80 mg/dL n=4 Participants
Corrected Total Serum Calcium Day 1 of cinacalcet treatment baseline	9.56 mg/dL n=5 Participants	9.86 mg/dL n=7 Participants	10.90 mg/dL n=5 Participants	9.80 mg/dL n=4 Participants
Ionized Calcium Extension study baseline	1.130 mmol/L n=5 Participants	1.145 mmol/L n=7 Participants	1.390 mmol/L n=5 Participants	1.140 mmol/L n=4 Participants
Ionized Calcium Day 1 of cinacalcet treatment baseline	1.130 mmol/L n=5 Participants	1.225 mmol/L n=7 Participants	1.340 mmol/L n=5 Participants	1.215 mmol/L n=4 Participants
Serum Phosphorus Extension study baseline	5.57 mg/dL n=5 Participants	6.05 mg/dL n=7 Participants	8.08 mg/dL n=5 Participants	5.85 mg/dL n=4 Participants
Serum Phosphorus Day 1 of cinacalcet treatment baseline	5.57 mg/dL n=5 Participants	5.75 mg/dL n=7 Participants	9.00 mg/dL n=5 Participants	5.74 mg/dL n=4 Participants
Calcium Phosphorus Product (Ca x P) Extension study baseline	54.42 mg²/dL² n=5 Participants	57.80 mg²/dL² n=7 Participants	82.28 mg²/dL² n=5 Participants	56.71 mg²/dL² n=4 Participants
Calcium Phosphorus Product (Ca x P) Day 1 of cinacalcet treatment baseline	54.42 mg²/dL² n=5 Participants	57.98 mg²/dL² n=7 Participants	98.90 mg²/dL² n=5 Participants	56.81 mg²/dL² n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.
Number of Participants With Adverse Events Fatal treatment-related adverse events	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Any adverse event (AE)	9 Participants	10 Participants	1 Participants
Number of Participants With Adverse Events AE Grade ≥ 2	2 Participants	7 Participants	1 Participants
Number of Participants With Adverse Events AE Grade ≥ 3	2 Participants	6 Participants	1 Participants
Number of Participants With Adverse Events AE Grade ≥ 4	0 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events Serious adverse event (SAE)	2 Participants	6 Participants	1 Participants
Number of Participants With Adverse Events AE leading to discontinuation of study drug	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Fatal adverse events	0 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events Treatment-related adverse events (TRAE)	5 Participants	4 Participants	0 Participants
Number of Participants With Adverse Events Treatment-related AE Grade ≥ 2	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events Treatment-related AE Grade ≥ 3	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Treatment-related AE Grade ≥ 4	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Treatment-related serious adverse events	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events TRAE leading to discontinuation of study drug	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	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.	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.
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15	30.8 percentage of participants Interval 9.1 to 61.4	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	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.	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.
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28	23.1 percentage of participants Interval 5.0 to 53.8	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	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.	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.
Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28	11.43 percent change Interval -20.64 to 27.27	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.
Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28	7.7 percentage of participants Interval 0.2 to 36.0	21.4 percentage of participants Interval 4.7 to 50.8	0.0 percentage of participants Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.
Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28	-0.24 mg/dL Interval -0.46 to -0.06	-0.24 mg/dL Interval -0.81 to 0.58	-0.74 mg/dL Interval -0.74 to -0.74

SECONDARY outcome

Timeframe: Extension study baseline and weeks 23 and 28

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.
Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28	0.19 mg/dL Interval -0.52 to 0.56	-0.08 mg/dL Interval -1.41 to 0.17	0.82 mg/dL Interval 0.82 to 0.82

SECONDARY outcome

Timeframe: Extension study baseline, week 11 and week 28

Data collected more than 7 days after the last dose of study drug were excluded.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.
Serum Corrected Calcium at Baseline, Week 11, and Week 28 Extension study baseline	9.56 mg/dL Interval 9.4 to 10.0	9.93 mg/dL Interval 9.02 to 10.16	10.29 mg/dL Interval 10.29 to 10.29
Serum Corrected Calcium at Baseline, Week 11, and Week 28 Week 11	9.35 mg/dL Interval 9.2 to 9.6	9.85 mg/dL Interval 9.3 to 10.65	—
Serum Corrected Calcium at Baseline, Week 11, and Week 28 Week 28	9.50 mg/dL Interval 9.3 to 10.0	9.90 mg/dL Interval 9.1 to 10.25	—

SECONDARY outcome

Timeframe: Extension study baseline, week 11 and week 28

Data collected more than 7 days after the last dose of study drug were excluded.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.
Serum Phosphorus at Baseline, Week 11, and Week 28 Extension study baseline	5.57 mg/dl Interval 4.86 to 6.19	6.05 mg/dl Interval 5.31 to 6.67	8.08 mg/dl Interval 8.08 to 8.08
Serum Phosphorus at Baseline, Week 11, and Week 28 Week 11	5.25 mg/dl Interval 4.55 to 5.8	6.20 mg/dl Interval 5.55 to 7.3	—
Serum Phosphorus at Baseline, Week 11, and Week 28 Week 28	5.00 mg/dl Interval 4.3 to 5.6	5.95 mg/dl Interval 5.7 to 6.8	—

SECONDARY outcome

Timeframe: Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.
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 Interval 9.1 to 61.4	35.7 percentage of participants Interval 12.8 to 64.9	100.0 percentage of participants Interval 2.5 to 100.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.
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 Interval 5.0 to 53.8	35.7 percentage of participants Interval 12.8 to 64.9	0.0 percentage of participants Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 3	10.16 percent change Interval -4.42 to 20.24	-6.88 percent change Interval -30.86 to 41.81	55.54 percent change Interval 55.54 to 55.54
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 7	1.99 percent change Interval -37.82 to 17.42	-4.96 percent change Interval -40.93 to 32.44	9.78 percent change Interval 9.78 to 9.78
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 11	19.75 percent change Interval -27.88 to 84.96	-7.64 percent change Interval -30.77 to 13.37	-7.00 percent change Interval -7.0 to -7.0
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 15	-7.67 percent change Interval -59.96 to 51.23	-13.04 percent change Interval -68.59 to 10.74	-73.85 percent change Interval -73.85 to -73.85
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 17	-23.93 percent change Interval -59.61 to 11.75	-3.09 percent change Interval -40.52 to 21.4	-20.02 percent change Interval -20.02 to -20.02
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 18	—	-29.85 percent change Interval -54.42 to 31.15	-7.49 percent change Interval -7.49 to -7.49
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 19	-37.17 percent change Interval -69.24 to 21.47	-3.50 percent change Interval -50.02 to 19.16	—
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 20	-13.12 percent change Interval -13.12 to -13.12	0.44 percent change Interval -35.1 to 66.13	160.80 percent change Interval 160.8 to 160.8
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 23	-9.05 percent change Interval -52.43 to 28.64	-6.65 percent change Interval -35.13 to 83.11	—
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 27	-8.50 percent change Interval -69.2 to 18.78	16.36 percent change Interval -59.79 to 50.23	—
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 31	—	32.30 percent change Interval -58.73 to 75.48	—
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 35	—	16.82 percent change Interval -70.15 to 82.83	—
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 39	—	0.09 percent change Interval -58.27 to 86.94	—
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 43	—	-17.13 percent change Interval -47.15 to 47.3	—
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 48	—	-45.67 percent change Interval -66.01 to 33.64	—
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time Week 52	—	86.50 percent change Interval 86.5 to 86.5	—
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time End of treatment	-8.50 percent change Interval -69.2 to 18.78	-45.67 percent change Interval -74.62 to 34.62	—
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time End of study	105.27 percent change Interval 105.27 to 105.27	20.21 percent change Interval 20.21 to 20.21	—

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 3	-0.18 mg/dL Interval -0.26 to -0.11	0.19 mg/dL Interval 0.05 to 0.32	-0.1 mg/dL Interval -0.1 to -0.1
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 7	-0.34 mg/dL Interval -0.44 to -0.24	-0.01 mg/dL Interval -0.23 to 0.21	-0.5 mg/dL Interval -0.5 to -0.5
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 11	-0.35 mg/dL Interval -0.46 to -0.24	-0.06 mg/dL Interval -0.19 to 0.07	-0.5 mg/dL Interval -0.5 to -0.5
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 15	-0.37 mg/dL Interval -0.62 to -0.12	0.06 mg/dL Interval -0.18 to 0.3	0.5 mg/dL Interval 0.5 to 0.5
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 17	-0.02 mg/dL Interval -0.24 to 0.2	-0.11 mg/dL Interval -0.45 to 0.22	-0.8 mg/dL Interval -0.8 to -0.8
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 18	—	-0.17 mg/dL Interval -0.35 to 0.02	-0.3 mg/dL Interval -0.3 to -0.3
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 19	-0.43 mg/dL Interval -0.6 to -0.26	-0.20 mg/dL Interval -0.37 to -0.03	-0.1 mg/dL Interval -0.1 to -0.1
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 20	—	-0.01 mg/dL Interval -0.18 to 0.16	—
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 21	—	-0.36 mg/dL Interval -0.63 to -0.09	-2.6 mg/dL Interval -2.6 to -2.6
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 23	-0.18 mg/dL Interval -0.24 to -0.12	-0.20 mg/dL Interval -0.47 to 0.08	—
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 27	-0.14 mg/dL Interval -0.25 to -0.02	-0.24 mg/dL Interval -0.41 to -0.07	—
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 31	—	-0.00 mg/dL Interval -0.2 to 0.19	—
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 35	—	-0.42 mg/dL Interval -0.57 to -0.26	—
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 39	—	-0.63 mg/dL Interval -0.84 to -0.43	—
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 43	—	-0.37 mg/dL Interval -0.63 to -0.11	—
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 48	—	-0.55 mg/dL Interval -0.87 to -0.23	—
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time Week 52	—	-0.16 mg/dL Interval -0.16 to -0.16	—
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time End of treatment	0.18 mg/dL Interval 0.02 to 0.34	-0.04 mg/dL Interval -0.26 to 0.18	—
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time End of study	1.00 mg/dL Interval 1.0 to 1.0	—	—

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	20130356 SOC n=13 Participants 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.	20130356 SOC + Cinacalcet n=14 Participants 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.	20110100 SOC + Cinacalcet n=1 Participants 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.
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 23	-0.37 mg/dL Interval -0.78 to 0.05	0.55 mg/dL Interval 0.12 to 0.98	—
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 3	-0.24 mg/dL Interval -0.56 to -0.08	0.81 mg/dL Interval -0.54 to 1.07	5.6 mg/dL Interval 5.6 to 5.6
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 7	-0.16 mg/dL Interval -0.5 to 0.17	0.37 mg/dL Interval 0.1 to 0.64	0.3 mg/dL Interval 0.3 to 0.3
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 11	0.01 mg/dL Interval -0.33 to 0.36	1.17 mg/dL Interval 0.87 to 1.47	0 mg/dL Interval 0.0 to 0.0
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 15	-0.52 mg/dL Interval -0.79 to -0.25	0.96 mg/dL Interval 0.71 to 1.2	-1.9 mg/dL Interval -1.9 to -1.9
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 17	-0.08 mg/dL Interval -0.19 to 0.03	1.57 mg/dL Interval 0.96 to 2.19	—
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 18	—	0.61 mg/dL Interval 0.3 to 0.93	-0.9 mg/dL Interval -0.9 to -0.9
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 19	-0.45 mg/dL Interval -0.74 to -0.16	0.91 mg/dL Interval 0.37 to 1.44	-0.3 mg/dL Interval -0.3 to -0.3
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 20	—	0.84 mg/dL Interval 0.16 to 1.51	—
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 21	—	0.17 mg/dL Interval -0.67 to 1.01	0.1 mg/dL Interval 0.1 to 0.1
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 27	-0.18 mg/dL Interval -0.53 to 0.18	0.76 mg/dL Interval 0.27 to 1.24	—
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 31	—	0.83 mg/dL Interval 0.24 to 1.42	—
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 35	—	-0.03 mg/dL Interval -0.51 to 0.45	—
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 39	—	0.40 mg/dL Interval -0.11 to 0.91	—
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 43	—	0.33 mg/dL Interval -0.21 to 0.86	—
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 48	—	0.60 mg/dL Interval -0.21 to 1.42	—
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time Week 52	—	0.61 mg/dL Interval 0.61 to 0.61	—
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time End of treatment	-0.18 mg/dL Interval -0.53 to 0.18	0.43 mg/dL Interval -0.25 to 1.11	—
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time End of study	1.20 mg/dL Interval 1.2 to 1.2	—	—

Adverse Events

20130356 SOC

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

20130356 SOC + Cinacalcet

Serious events: 6 serious events

Other events: 10 other events

Deaths: 0 deaths

20110100 SOC + Cinacalcet

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Total

Serious events: 9 serious events

Other events: 20 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	20130356 SOC n=13 participants at risk 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.	20130356 SOC + Cinacalcet n=14 participants at risk 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.	20110100 SOC + Cinacalcet n=1 participants at risk 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.	Total n=28 participants at risk All participants who received cinacalcet in study 20140159.
Blood and lymphatic system disorders Anaemia	7.7% 1/13 • 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.	0.00% 0/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
Endocrine disorders Goitre	7.7% 1/13 • 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.	0.00% 0/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
General disorders Fatigue	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
General disorders Local swelling	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
General disorders Pyrexia	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
Infections and infestations Cellulitis	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
Infections and infestations Device related infection	0.00% 0/13 • 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.	14.3% 2/14 • 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.	0.00% 0/1 • 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.	7.1% 2/28 • 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.
Infections and infestations Pericarditis infective	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
Infections and infestations Pneumonia	0.00% 0/13 • 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.	0.00% 0/14 • 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.	100.0% 1/1 • 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.	3.6% 1/28 • 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.
Infections and infestations Staphylococcal infection	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
Infections and infestations Urinary tract infection	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
Product Issues Device damage	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
Product Issues Device dislocation	0.00% 0/13 • 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.	7.1% 1/14 • 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.	100.0% 1/1 • 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.	7.1% 2/28 • 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.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
Surgical and medical procedures Catheter placement	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.
Vascular disorders Venous occlusion	0.00% 0/13 • 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.	7.1% 1/14 • 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.	0.00% 0/1 • 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.	3.6% 1/28 • 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.