Trial Outcomes & Findings for Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide (NCT NCT01932970)

NCT ID: NCT01932970

Last Updated: 2018-10-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 158 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2018-10-17

Participant Flow

This study was conducted at 33 centers in the United States. Participants were enrolled from 1 September 2013 to 9 December 2013. Participants were required to be on a stable dose of daily oral cinacalcet for a minimum of 4 weeks before screening, and during the 4 weeks of screening.

Upon enrollment, participants underwent a washout period of a minimum of 7 days, wherein no cinacalcet use was allowed. Participants who had a serum corrected calcium ≥ 8.3 mg/dL during the washout period entered the treatment phase and were categorized based on their pre-washout, screening cinacalcet daily dose level (30 mg, 60 mg or ≥ 90 mg).

Participant milestones

Measure	Etelcalcetide Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Overall Study STARTED	158
Overall Study Received Treatment	148
Overall Study COMPLETED	140
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure	Etelcalcetide Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Overall Study Withdrawal by Subject	5
Overall Study Death	1
Overall Study Lost to Follow-up	2
Overall Study Protocol Specified Criteria	10

Baseline Characteristics

Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

Baseline characteristics by cohort

Measure	Etelcalcetide n=147 Participants Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Age, Continuous	56.5 years STANDARD_DEVIATION 14.0 • n=5 Participants
Age, Customized < 65 years	106 participants n=5 Participants
Age, Customized ≥ 65 years	41 participants n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants
Race American Indian or Alaska Native	1 participants n=5 Participants
Race Asian	12 participants n=5 Participants
Race Black (or African American)	68 participants n=5 Participants
Race Native Hawaiian or Other Pacific Islander	2 participants n=5 Participants
Race White	64 participants n=5 Participants
Ethnicity Hispanic/Latino	39 participants n=5 Participants
Ethnicity Not Hispanic/Latino	108 participants n=5 Participants
Corrected Calcium	9.81 mg/dL STANDARD_DEVIATION 0.75 • n=5 Participants
Parathyroid Hormone	786.3 pg/mL STANDARD_DEVIATION 467.8 • n=5 Participants
Phosphorus	5.88 mg/dL STANDARD_DEVIATION 1.71 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Full analysis set

Outcome measures

Measure	Etelcalcetide n=147 Participants Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period	0.7 percentage of participants Interval 0.0 to 3.7

SECONDARY outcome

Timeframe: Baseline and weeks 2, 3 and 4

Population: Full analysis set with available data at each time point

Outcome measures

Measure	Etelcalcetide n=140 Participants Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Percent Change From Baseline in Parathyroid Hormone During the Treatment Period Week 2 (n = 125)	-3.9 percent change Standard Error 2.6
Percent Change From Baseline in Parathyroid Hormone During the Treatment Period Week 3 (n = 131)	-7.8 percent change Standard Error 3.1
Percent Change From Baseline in Parathyroid Hormone During the Treatment Period Week 4 (n = 123)	-10.9 percent change Standard Error 2.9

SECONDARY outcome

Timeframe: 4 weeks

Population: Full analysis set

Outcome measures

Measure	Etelcalcetide n=147 Participants Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period	15.6 percentage of participants Interval 10.2 to 22.5

OTHER_PRE_SPECIFIED outcome

Timeframe: From the first dose of study drug up to 30 days after the last dose; 8 weeks

Population: All participants who received at least one dose of study drug

Outcome measures

Measure	Etelcalcetide n=148 Participants Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Number of Participants With Adverse Events Any adverse event (AE)	72 participants
Number of Participants With Adverse Events Serious adverse event (SAE)	17 participants
Number of Participants With Adverse Events AE leading to discontinuation of etelcalcetide	2 participants
Number of Participants With Adverse Events Fatal adverse event	1 participants
Number of Participants With Adverse Events Treatment-related adverse event	11 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the first dose of study drug up to 30 days after the last dose; 8 weeks

Population: Participants who received at least one dose of study drug

Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia.

Outcome measures

Measure	Etelcalcetide n=148 Participants Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period	0.0 percentage of participants Interval 0.0 to 2.5

Adverse Events

Etelcalcetide

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Etelcalcetide n=148 participants at risk Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Cardiac disorders Acute myocardial infarction	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac arrest	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Bile duct obstruction	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Arteriovenous graft site infection	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Biliary sepsis	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Osteomyelitis	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	1.4% 2/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Staphylococcal bacteraemia	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Hip fracture	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural hypotension	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood glucose increased	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Fluid overload	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperkalaemia	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular accident	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Mental status changes	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.68% 1/148 • From the first dose of study drug up to 30 days after the last dose; up to 8 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

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