Trial Outcomes & Findings for Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder (NCT NCT01414114)
NCT ID: NCT01414114
Last Updated: 2017-04-11
Results Overview
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Results posted on
2017-04-11
Participant Flow
This study was conducted at 5 centers in the United States from 05 December 2011 (first participant enrolled) to 21 May 2012 (last participant completed follow-up).
Participant milestones
| Measure |
Etelcalcetide
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
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|---|---|
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Overall Study
STARTED
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37
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Overall Study
COMPLETED
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32
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
| Measure |
Etelcalcetide
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
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|---|---|
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Overall Study
Adverse Event
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2
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Other
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2
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Baseline Characteristics
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
Baseline characteristics by cohort
| Measure |
Etelcalcetide
n=37 Participants
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
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|---|---|
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Age, Continuous
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56.5 years
STANDARD_DEVIATION 13.30 • n=5 Participants
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Sex: Female, Male
Female
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18 Participants
n=5 Participants
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Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
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Race
White
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18 Participants
n=5 Participants
|
|
Race
Black or African American
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19 Participants
n=5 Participants
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Ethnicity
Hispanic or Latino
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11 Participants
n=5 Participants
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Ethnicity
Not Hispanic or Latino
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26 Participants
n=5 Participants
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Parathyroid Hormone (PTH)
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853.4 pg/mL
STANDARD_DEVIATION 644.25 • n=5 Participants
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Parathyroid Hormone Category
≤ 700 pg/mL
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22 Participants
n=5 Participants
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Parathyroid Hormone Category
> 700 pg/mL
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15 Participants
n=5 Participants
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Corrected Calcium
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10.1 mg/dL
STANDARD_DEVIATION 0.62 • n=5 Participants
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Phosphorus
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5.7 mg/dL
STANDARD_DEVIATION 1.38 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)Population: The modified intent-to-treat population (all participants who were randomized and received treatment) with available data at both time points.
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Outcome measures
| Measure |
Etelcalcetide
n=36 Participants
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
|
Baseline PTH ≤ 700 pg/mL
n=21 Participants
Participants with baseline PTH ≤ 700 pg/mL
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Baseline PTH > 700 pg/mL
n=15 Participants
Participants with baseline PTH \> 700 pg/mL
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|---|---|---|---|
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Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period
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-53.6 percent change
Standard Deviation 21.42
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-55.6 percent change
Standard Deviation 19.65
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-50.8 percent change
Standard Deviation 24.12
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SECONDARY outcome
Timeframe: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)Population: Modified intent-to-treat population with available data
The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Outcome measures
| Measure |
Etelcalcetide
n=36 Participants
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
|
Baseline PTH ≤ 700 pg/mL
n=21 Participants
Participants with baseline PTH ≤ 700 pg/mL
|
Baseline PTH > 700 pg/mL
n=15 Participants
Participants with baseline PTH \> 700 pg/mL
|
|---|---|---|---|
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Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period
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89 percentage of participants
Interval 73.9 to 96.9
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95 percentage of participants
Interval 76.2 to 99.9
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80 percentage of participants
Interval 51.9 to 95.7
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SECONDARY outcome
Timeframe: The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)Population: Modified intent-to-treat population with available data
The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Outcome measures
| Measure |
Etelcalcetide
n=36 Participants
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
|
Baseline PTH ≤ 700 pg/mL
n=21 Participants
Participants with baseline PTH ≤ 700 pg/mL
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Baseline PTH > 700 pg/mL
n=15 Participants
Participants with baseline PTH \> 700 pg/mL
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|---|---|---|---|
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Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period
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56 percentage of participants
Interval 38.1 to 72.1
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76 percentage of participants
Interval 52.8 to 91.8
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27 percentage of participants
Interval 7.8 to 55.1
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SECONDARY outcome
Timeframe: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)Population: Modified intent-to-treat population with available data at both time points
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Outcome measures
| Measure |
Etelcalcetide
n=36 Participants
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
|
Baseline PTH ≤ 700 pg/mL
n=21 Participants
Participants with baseline PTH ≤ 700 pg/mL
|
Baseline PTH > 700 pg/mL
n=15 Participants
Participants with baseline PTH \> 700 pg/mL
|
|---|---|---|---|
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Percent Change From Baseline in Corrected Calcium During the Efficacy Period
|
-15.1 percent change
Standard Deviation 5.76
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-13.0 percent change
Standard Deviation 4.83
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-17.9 percent change
Standard Deviation 5.91
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SECONDARY outcome
Timeframe: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)Population: Modified intent-to-treat population with available data at both time points
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Outcome measures
| Measure |
Etelcalcetide
n=36 Participants
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
|
Baseline PTH ≤ 700 pg/mL
n=21 Participants
Participants with baseline PTH ≤ 700 pg/mL
|
Baseline PTH > 700 pg/mL
n=15 Participants
Participants with baseline PTH \> 700 pg/mL
|
|---|---|---|---|
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Percent Change From Baseline in Phosphorus During the Efficacy Period
|
-10.4 percent change
Standard Deviation 19.78
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-7.7 percent change
Standard Deviation 21.92
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-14.2 percent change
Standard Deviation 16.27
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Adverse Events
Etelcalcetide
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etelcalcetide
n=37 participants at risk
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
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|---|---|
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Cardiac disorders
Acute myocardial infarction
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2.7%
1/37 • From the first dose of study drug up to 4 weeks after the last dose; 16 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiogenic shock
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2.7%
1/37 • From the first dose of study drug up to 4 weeks after the last dose; 16 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
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2.7%
1/37 • From the first dose of study drug up to 4 weeks after the last dose; 16 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal obstruction
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2.7%
1/37 • From the first dose of study drug up to 4 weeks after the last dose; 16 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
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2.7%
1/37 • From the first dose of study drug up to 4 weeks after the last dose; 16 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
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2.7%
1/37 • From the first dose of study drug up to 4 weeks after the last dose; 16 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Etelcalcetide
n=37 participants at risk
Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
|
|---|---|
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Gastrointestinal disorders
Diarrhoea
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13.5%
5/37 • From the first dose of study drug up to 4 weeks after the last dose; 16 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
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5.4%
2/37 • From the first dose of study drug up to 4 weeks after the last dose; 16 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.1%
3/37 • From the first dose of study drug up to 4 weeks after the last dose; 16 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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Investigations
Blood calcium decreased
|
24.3%
9/37 • From the first dose of study drug up to 4 weeks after the last dose; 16 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.8%
4/37 • From the first dose of study drug up to 4 weeks after the last dose; 16 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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