Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism (NCT NCT01134562)
NCT ID: NCT01134562
Last Updated: 2018-01-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Results posted on
2018-01-02
Participant Flow
This study was conducted at 1 center in Australia and 2 centers in the United States from 07 September 2010 to 02 April 2011.
Cohorts 1-3 were conducted with a two-period crossover design. Each cohort enrolled four participants randomized 1:1 to etelcalcetide followed by placebo or placebo followed by etelcalcetide. Cohorts 4 and 5 followed a parallel group design. Within each cohort eight participants were randomized 1:1 to receive placebo or etelcalcetide.
Participant milestones
| Measure |
Cohort 1: Placebo/Etelcalcetide 5 mg
Participants in Cohort 1 received single doses of 5 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
|
Cohort 2: Placebo/Etelcalcetide 10 mg
Participants in Cohort 2 received single doses of 10 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
|
Cohort 3: Placebo/Etelcalcetide 20 mg
Participants in Cohort 3 received single doses of 20 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
|
Cohort 4: Placebo/Etelcalcetide 40 mg
Participants in Cohort 4 received a single dose of 40 mg etelcalcetide or placebo in a parallel group design.
|
Cohort 5: Placebo/Etelcalcetide 60 mg
Participants in Cohort 5 received a single dose of 60 mg etelcalcetide or placebo in a parallel group design.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
8
|
8
|
|
Overall Study
COMPLETED
|
4
|
3
|
4
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Placebo/Etelcalcetide 5 mg
Participants in Cohort 1 received single doses of 5 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
|
Cohort 2: Placebo/Etelcalcetide 10 mg
Participants in Cohort 2 received single doses of 10 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
|
Cohort 3: Placebo/Etelcalcetide 20 mg
Participants in Cohort 3 received single doses of 20 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
|
Cohort 4: Placebo/Etelcalcetide 40 mg
Participants in Cohort 4 received a single dose of 40 mg etelcalcetide or placebo in a parallel group design.
|
Cohort 5: Placebo/Etelcalcetide 60 mg
Participants in Cohort 5 received a single dose of 60 mg etelcalcetide or placebo in a parallel group design.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Baseline characteristics by cohort
| Measure |
Cohort 1: Placebo/Etelcalcetide 5 mg
n=4 Participants
Participants in Cohort 1 received single doses of 5 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
|
Cohort 2: Placebo/Etelcalcetide 10 mg
n=4 Participants
Participants in Cohort 2 received single doses of 10 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
|
Cohort 3: Placebo/Etelcalcetide 20 mg
n=4 Participants
Participants in Cohort 3 received single doses of 20 mg etelcalcetide and placebo in a crossover design, 7-14 days apart
|
Cohort 4: Placebo/Etelcalcetide 40 mg
n=8 Participants
Participants in Cohort 4 received a single dose of 40 mg etelcalcetide or placebo in a parallel group design.
|
Cohort 5: Placebo/Etelcalcetide 60 mg
n=8 Participants
Participants in Cohort 5 received a single dose of 60 mg etelcalcetide or placebo in a parallel group design.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 21.2 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 14.6 • n=4 Participants
|
47.5 years
STANDARD_DEVIATION 10.9 • n=21 Participants
|
52.4 years
STANDARD_DEVIATION 13.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Race
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race
African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Race
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity
Non-Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.Population: All participants who were randomized and received any amount of study medication.
Outcome measures
| Measure |
Pooled Placebo
n=20 Participants
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=4 Participants
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=3 Participants
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
n=4 Participants
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=4 Participants
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
n=4 Participants
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any adverse events
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Withdrawal due to adverse events
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Deaths due to adverse events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Treatment-related adverse events
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29Population: Participants who were randomized and received any amount of study medication with available data at each time point. Only participants in Cohorts 4 and 5 had PTH assessed on days 8, 15 and 29.
Outcome measures
| Measure |
Pooled Placebo
n=20 Participants
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=4 Participants
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=3 Participants
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
n=4 Participants
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=4 Participants
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
n=4 Participants
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
30 Minutes
|
1.381 percent change
Standard Deviation 20.429
|
-63.179 percent change
Standard Deviation 5.135
|
-68.890 percent change
Standard Deviation 9.616
|
-70.021 percent change
Standard Deviation 11.273
|
-72.435 percent change
Standard Deviation 11.176
|
-77.471 percent change
Standard Deviation 5.979
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
1 Hour
|
-0.540 percent change
Standard Deviation 17.092
|
-64.094 percent change
Standard Deviation 4.547
|
-73.060 percent change
Standard Deviation 7.959
|
-70.309 percent change
Standard Deviation 9.601
|
-75.898 percent change
Standard Deviation 11.333
|
-78.757 percent change
Standard Deviation 4.921
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
4 Hours
|
3.922 percent change
Standard Deviation 30.491
|
-39.975 percent change
Standard Deviation 14.961
|
-51.734 percent change
Standard Deviation 23.294
|
-72.893 percent change
Standard Deviation 14.821
|
-74.627 percent change
Standard Deviation 13.479
|
-80.266 percent change
Standard Deviation 7.476
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
8 Hours
|
4.014 percent change
Standard Deviation 25.061
|
-39.789 percent change
Standard Deviation 9.694
|
-52.075 percent change
Standard Deviation 16.841
|
-70.904 percent change
Standard Deviation 15.663
|
-77.031 percent change
Standard Deviation 8.236
|
-84.184 percent change
Standard Deviation 6.461
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
18 Hours
|
-13.552 percent change
Standard Deviation 25.000
|
-23.751 percent change
Standard Deviation 10.615
|
-48.744 percent change
Standard Deviation 15.460
|
-72.653 percent change
Standard Deviation 16.154
|
-78.332 percent change
Standard Deviation 7.393
|
-85.547 percent change
Standard Deviation 6.056
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
24 Hours
|
-16.888 percent change
Standard Deviation 30.497
|
-23.420 percent change
Standard Deviation 10.289
|
-46.642 percent change
Standard Deviation 18.136
|
-41.723 percent change
Standard Deviation 26.353
|
-77.206 percent change
Standard Deviation 4.005
|
-84.845 percent change
Standard Deviation 6.208
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
32 Hours
|
-16.434 percent change
Standard Deviation 34.774
|
-18.406 percent change
Standard Deviation 15.484
|
-32.987 percent change
Standard Deviation 26.492
|
-55.919 percent change
Standard Deviation 33.153
|
-69.795 percent change
Standard Deviation 4.812
|
-83.439 percent change
Standard Deviation 5.802
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
42 Hours
|
-20.394 percent change
Standard Deviation 25.119
|
-9.087 percent change
Standard Deviation 10.439
|
-34.912 percent change
Standard Deviation 22.835
|
-57.207 percent change
Standard Deviation 32.894
|
-63.258 percent change
Standard Deviation 5.239
|
-76.096 percent change
Standard Deviation 9.079
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
48 Hours
|
-21.664 percent change
Standard Deviation 28.956
|
-14.905 percent change
Standard Deviation 16.588
|
-36.142 percent change
Standard Deviation 24.957
|
-43.145 percent change
Standard Deviation 43.175
|
-55.486 percent change
Standard Deviation 1.761
|
-71.268 percent change
Standard Deviation 11.557
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
56 Hours
|
-15.484 percent change
Standard Deviation 33.626
|
-2.968 percent change
Standard Deviation 20.870
|
-21.994 percent change
Standard Deviation 34.015
|
-43.271 percent change
Standard Deviation 44.442
|
-48.128 percent change
Standard Deviation 3.740
|
-60.112 percent change
Standard Deviation 16.074
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
Day 4-Discharge
|
-11.192 percent change
Standard Deviation 33.131
|
-7.428 percent change
Standard Deviation 15.016
|
13.264 percent change
Standard Deviation 23.682
|
-48.533 percent change
Standard Deviation 32.739
|
-49.277 percent change
Standard Deviation 6.274
|
-62.628 percent change
Standard Deviation 12.335
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
Day 8
|
-31.881 percent change
Standard Deviation 38.536
|
—
|
—
|
—
|
-30.766 percent change
Standard Deviation 32.248
|
-61.093 percent change
Standard Deviation 5.804
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
Day 15
|
-33.993 percent change
Standard Deviation 44.928
|
—
|
—
|
—
|
-34.149 percent change
Standard Deviation 22.536
|
-58.510 percent change
Standard Deviation 15.169
|
|
Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
Day 29
|
-31.394 percent change
Standard Deviation 47.249
|
—
|
—
|
—
|
-14.750 percent change
Standard Deviation 28.303
|
-44.478 percent change
Standard Deviation 16.631
|
SECONDARY outcome
Timeframe: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29Population: Participants who were randomized and received any amount of study medication and with available data at each time point. Only participants in Cohorts 4 and 5 had serum corrected calcium assessed on days 8, 15 and 29.
Outcome measures
| Measure |
Pooled Placebo
n=20 Participants
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=4 Participants
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=3 Participants
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
n=4 Participants
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=4 Participants
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
n=4 Participants
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Corrected Calcium
30 Minutes
|
0.024 percent change
Standard Deviation 3.881
|
0.106 percent change
Standard Deviation 4.550
|
-2.883 percent change
Standard Deviation 2.457
|
-2.589 percent change
Standard Deviation 1.665
|
-0.572 percent change
Standard Deviation 2.126
|
1.951 percent change
Standard Deviation 6.723
|
|
Percent Change From Baseline in Serum Corrected Calcium
1 Hour
|
-0.295 percent change
Standard Deviation 4.644
|
0.256 percent change
Standard Deviation 1.043
|
-5.176 percent change
Standard Deviation 2.874
|
-2.574 percent change
Standard Deviation 1.335
|
-3.700 percent change
Standard Deviation 3.395
|
3.445 percent change
Standard Deviation 9.876
|
|
Percent Change From Baseline in Serum Corrected Calcium
4 Hours
|
0.540 percent change
Standard Deviation 4.998
|
-3.427 percent change
Standard Deviation 1.201
|
-7.795 percent change
Standard Deviation 2.473
|
-5.515 percent change
Standard Deviation 1.939
|
-3.599 percent change
Standard Deviation 2.991
|
-1.258 percent change
Standard Deviation 10.241
|
|
Percent Change From Baseline in Serum Corrected Calcium
8 Hours
|
0.945 percent change
Standard Deviation 5.894
|
-5.533 percent change
Standard Deviation 8.724
|
-10.697 percent change
Standard Deviation 4.257
|
-7.685 percent change
Standard Deviation 2.633
|
-5.895 percent change
Standard Deviation 5.393
|
-4.057 percent change
Standard Deviation 10.732
|
|
Percent Change From Baseline in Serum Corrected Calcium
18 Hours
|
3.669 percent change
Standard Deviation 7.885
|
-3.103 percent change
Standard Deviation 3.399
|
-8.018 percent change
Standard Deviation 6.150
|
-9.560 percent change
Standard Deviation 4.703
|
-5.993 percent change
Standard Deviation 9.270
|
-5.738 percent change
Standard Deviation 10.402
|
|
Percent Change From Baseline in Serum Corrected Calcium
24 Hours
|
3.853 percent change
Standard Deviation 8.667
|
-3.003 percent change
Standard Deviation 4.149
|
-8.826 percent change
Standard Deviation 2.766
|
-11.436 percent change
Standard Deviation 5.463
|
-8.436 percent change
Standard Deviation 10.582
|
-5.688 percent change
Standard Deviation 9.762
|
|
Percent Change From Baseline in Serum Corrected Calcium
32 Hours
|
3.079 percent change
Standard Deviation 9.187
|
-1.632 percent change
Standard Deviation 7.315
|
-9.436 percent change
Standard Deviation 2.192
|
-10.644 percent change
Standard Deviation 8.525
|
-6.155 percent change
Standard Deviation 12.748
|
-7.146 percent change
Standard Deviation 10.382
|
|
Percent Change From Baseline in Serum Corrected Calcium
42 Hours
|
3.209 percent change
Standard Deviation 9.716
|
-4.815 percent change
Standard Deviation 8.629
|
-9.049 percent change
Standard Deviation 3.745
|
-11.700 percent change
Standard Deviation 8.151
|
-9.186 percent change
Standard Deviation 8.793
|
-9.082 percent change
Standard Deviation 7.392
|
|
Percent Change From Baseline in Serum Corrected Calcium
48 Hours
|
2.918 percent change
Standard Deviation 8.965
|
-2.781 percent change
Standard Deviation 7.855
|
-9.115 percent change
Standard Deviation 0.280
|
-9.458 percent change
Standard Deviation 7.873
|
-8.174 percent change
Standard Deviation 9.005
|
-10.911 percent change
Standard Deviation 9.479
|
|
Percent Change From Baseline in Serum Corrected Calcium
56 Hours
|
1.920 percent change
Standard Deviation 10.339
|
-1.583 percent change
Standard Deviation 4.258
|
-10.338 percent change
Standard Deviation 4.119
|
-9.227 percent change
Standard Deviation 6.946
|
-8.970 percent change
Standard Deviation 8.789
|
-12.300 percent change
Standard Deviation 9.491
|
|
Percent Change From Baseline in Serum Corrected Calcium
Day 4-Discharge
|
1.556 percent change
Standard Deviation 10.240
|
-2.577 percent change
Standard Deviation 12.131
|
-7.405 percent change
Standard Deviation 4.208
|
-9.200 percent change
Standard Deviation 6.760
|
-8.180 percent change
Standard Deviation 9.334
|
-13.186 percent change
Standard Deviation 9.781
|
|
Percent Change From Baseline in Serum Corrected Calcium
Day 8
|
0.632 percent change
Standard Deviation 10.506
|
—
|
—
|
—
|
-3.985 percent change
Standard Deviation 12.631
|
-8.859 percent change
Standard Deviation 3.740
|
|
Percent Change From Baseline in Serum Corrected Calcium
Day 15
|
3.827 percent change
Standard Deviation 8.196
|
—
|
—
|
—
|
-0.238 percent change
Standard Deviation 8.371
|
-6.885 percent change
Standard Deviation 9.669
|
|
Percent Change From Baseline in Serum Corrected Calcium
Day 29
|
4.228 percent change
Standard Deviation 9.346
|
—
|
—
|
—
|
2.221 percent change
Standard Deviation 2.378
|
3.620 percent change
Standard Deviation 7.196
|
SECONDARY outcome
Timeframe: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).Population: Participants who were randomized and received any amount of study medication with available data at each time point
Outcome measures
| Measure |
Pooled Placebo
n=20 Participants
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=4 Participants
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=3 Participants
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
n=4 Participants
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=4 Participants
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
n=3 Participants
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Ionized Calcium
30 Minutes
|
-0.118 percent change
Standard Deviation 2.920
|
0.234 percent change
Standard Deviation 2.172
|
-2.940 percent change
Standard Deviation 4.619
|
-0.122 percent change
Standard Deviation 2.400
|
-0.934 percent change
Standard Deviation 2.007
|
-3.300 percent change
Standard Deviation 5.716
|
|
Percent Change From Baseline in Ionized Calcium
1 Hour
|
-0.151 percent change
Standard Deviation 2.577
|
-1.406 percent change
Standard Deviation 3.173
|
-1.394 percent change
Standard Deviation 3.841
|
-0.442 percent change
Standard Deviation 4.233
|
-3.072 percent change
Standard Deviation 7.850
|
1.595 percent change
Standard Deviation 1.118
|
|
Percent Change From Baseline in Ionized Calcium
4 Hours
|
0.744 percent change
Standard Deviation 3.126
|
-3.436 percent change
Standard Deviation 4.124
|
-6.015 percent change
Standard Deviation 1.847
|
-3.550 percent change
Standard Deviation 4.054
|
-3.759 percent change
Standard Deviation 11.275
|
-1.514 percent change
Standard Deviation 3.049
|
|
Percent Change From Baseline in Ionized Calcium
8 Hours
|
1.924 percent change
Standard Deviation 4.128
|
-0.703 percent change
Standard Deviation 4.896
|
-6.218 percent change
Standard Deviation 2.395
|
-7.160 percent change
Standard Deviation 6.947
|
-3.867 percent change
Standard Deviation 10.572
|
-8.652 percent change
Standard Deviation 3.231
|
|
Percent Change From Baseline in Ionized Calcium
18 Hours
|
6.570 percent change
Standard Deviation 5.729
|
-2.168 percent change
Standard Deviation 4.508
|
-4.125 percent change
Standard Deviation 3.667
|
-6.571 percent change
Standard Deviation 5.425
|
-3.949 percent change
Standard Deviation 5.644
|
-12.139 percent change
Standard Deviation 5.122
|
|
Percent Change From Baseline in Ionized Calcium
24 Hours
|
6.920 percent change
Standard Deviation 6.835
|
-0.663 percent change
Standard Deviation 3.640
|
-3.822 percent change
Standard Deviation 3.953
|
-7.093 percent change
Standard Deviation 8.308
|
-5.395 percent change
Standard Deviation 11.404
|
-10.916 percent change
Standard Deviation 4.793
|
|
Percent Change From Baseline in Ionized Calcium
32 Hours
|
5.925 percent change
Standard Deviation 7.251
|
0.918 percent change
Standard Deviation 3.431
|
-2.830 percent change
Standard Deviation 5.873
|
-4.044 percent change
Standard Deviation 11.718
|
-5.090 percent change
Standard Deviation 10.317
|
-7.627 percent change
Standard Deviation 2.563
|
|
Percent Change From Baseline in Ionized Calcium
42 Hours
|
8.157 percent change
Standard Deviation 8.080
|
-0.456 percent change
Standard Deviation 3.392
|
-4.213 percent change
Standard Deviation 1.195
|
-5.980 percent change
Standard Deviation 8.479
|
-3.212 percent change
Standard Deviation 6.593
|
-12.00 percent change
Standard Deviation 3.337
|
|
Percent Change From Baseline in Ionized Calcium
48 Hours
|
6.080 percent change
Standard Deviation 8.323
|
-1.376 percent change
Standard Deviation 4.136
|
-2.919 percent change
Standard Deviation 3.392
|
-5.282 percent change
Standard Deviation 9.031
|
-2.468 percent change
Standard Deviation 9.489
|
-13.449 percent change
Standard Deviation 3.961
|
|
Percent Change From Baseline in Ionized Calcium
56 Hours
|
5.991 percent change
Standard Deviation 7.704
|
0.612 percent change
Standard Deviation 5.530
|
-3.780 percent change
Standard Deviation 4.981
|
-3.766 percent change
Standard Deviation 9.005
|
-3.052 percent change
Standard Deviation 8.958
|
-11.229 percent change
Standard Deviation 4.218
|
|
Percent Change From Baseline in Ionized Calcium
Day 4-Discharge
|
6.152 percent change
Standard Deviation 8.162
|
2.765 percent change
Standard Deviation 4.557
|
-1.697 percent change
Standard Deviation 4.582
|
-1.174 percent change
Standard Deviation 9.134
|
1.601 percent change
Standard Deviation 12.279
|
-12.798 percent change
Standard Deviation 3.424
|
SECONDARY outcome
Timeframe: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).Population: Participants who were randomized and received any amount of study medication with available data at each time point.
Outcome measures
| Measure |
Pooled Placebo
n=20 Participants
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=4 Participants
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=3 Participants
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
n=4 Participants
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=4 Participants
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
n=4 Participants
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Phosphorus
30 Minutes
|
6.453 percent change
Standard Deviation 10.400
|
2.080 percent change
Standard Deviation 4.235
|
-0.255 percent change
Standard Deviation 12.843
|
5.498 percent change
Standard Deviation 1.546
|
9.024 percent change
Standard Deviation 10.125
|
5.608 percent change
Standard Deviation 4.474
|
|
Percent Change From Baseline in Serum Phosphorus
1 Hour
|
10.907 percent change
Standard Deviation 10.912
|
8.750 percent change
Standard Deviation 5.519
|
2.219 percent change
Standard Deviation 15.246
|
12.164 percent change
Standard Deviation 5.483
|
11.018 percent change
Standard Deviation 5.492
|
8.621 percent change
Standard Deviation 4.780
|
|
Percent Change From Baseline in Serum Phosphorus
4 Hours
|
34.009 percent change
Standard Deviation 16.904
|
34.441 percent change
Standard Deviation 12.211
|
15.334 percent change
Standard Deviation 4.080
|
29.231 percent change
Standard Deviation 15.513
|
30.927 percent change
Standard Deviation 8.124
|
19.261 percent change
Standard Deviation 9.807
|
|
Percent Change From Baseline in Serum Phosphorus
8 Hours
|
51.998 percent change
Standard Deviation 27.762
|
41.575 percent change
Standard Deviation 33.433
|
9.325 percent change
Standard Deviation 5.563
|
27.684 percent change
Standard Deviation 12.520
|
30.640 percent change
Standard Deviation 24.248
|
32.465 percent change
Standard Deviation 15.418
|
|
Percent Change From Baseline in Serum Phosphorus
18 Hours
|
69.207 percent change
Standard Deviation 41.794
|
62.681 percent change
Standard Deviation 26.476
|
9.206 percent change
Standard Deviation 2.538
|
30.352 percent change
Standard Deviation 22.143
|
32.018 percent change
Standard Deviation 14.688
|
26.240 percent change
Standard Deviation 19.622
|
|
Percent Change From Baseline in Serum Phosphorus
24 Hours
|
69.676 percent change
Standard Deviation 45.038
|
55.497 percent change
Standard Deviation 29.444
|
-0.574 percent change
Standard Deviation 8.659
|
32.376 percent change
Standard Deviation 28.527
|
24.240 percent change
Standard Deviation 37.457
|
24.655 percent change
Standard Deviation 27.651
|
|
Percent Change From Baseline in Serum Phosphorus
32 Hours
|
81.616 percent change
Standard Deviation 48.245
|
67.662 percent change
Standard Deviation 43.365
|
12.914 percent change
Standard Deviation 6.547
|
29.678 percent change
Standard Deviation 15.174
|
32.705 percent change
Standard Deviation 28.481
|
43.411 percent change
Standard Deviation 19.010
|
|
Percent Change From Baseline in Serum Phosphorus
42 Hours
|
82.478 percent change
Standard Deviation 44.276
|
72.340 percent change
Standard Deviation 35.380
|
15.357 percent change
Standard Deviation 8.616
|
35.259 percent change
Standard Deviation 31.535
|
43.149 percent change
Standard Deviation 25.219
|
36.299 percent change
Standard Deviation 31.742
|
|
Percent Change From Baseline in Serum Phosphorus
48 Hours
|
80.245 percent change
Standard Deviation 48.363
|
66.536 percent change
Standard Deviation 45.455
|
10.970 percent change
Standard Deviation 11.808
|
34.452 percent change
Standard Deviation 31.330
|
43.624 percent change
Standard Deviation 29.435
|
55.718 percent change
Standard Deviation 35.112
|
|
Percent Change From Baseline in Serum Phosphorus
56 Hours
|
83.741 percent change
Standard Deviation 51.885
|
98.775 percent change
Standard Deviation 67.669
|
17.867 percent change
Standard Deviation 18.308
|
35.569 percent change
Standard Deviation 21.851
|
43.033 percent change
Standard Deviation 33.634
|
63.990 percent change
Standard Deviation 28.031
|
|
Percent Change From Baseline in Serum Phosphorus
Day 4-Discharge
|
83.535 percent change
Standard Deviation 44.193
|
78.775 percent change
Standard Deviation 45.141
|
23.022 percent change
Standard Deviation 12.403
|
54.242 percent change
Standard Deviation 30.386
|
59.563 percent change
Standard Deviation 19.668
|
56.708 percent change
Standard Deviation 29.407
|
SECONDARY outcome
Timeframe: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).Population: Participants who were randomized and received any amount of study medication with available data at each time point.
Outcome measures
| Measure |
Pooled Placebo
n=20 Participants
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=4 Participants
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=3 Participants
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
n=4 Participants
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=4 Participants
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
n=4 Participants
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Calcium Phosphorus Product
56 Hours
|
88.531 percent change
Standard Deviation 59.100
|
93.793 percent change
Standard Deviation 59.933
|
5.483 percent change
Standard Deviation 15.538
|
23.351 percent change
Standard Deviation 25.107
|
31.825 percent change
Standard Deviation 42.108
|
44.582 percent change
Standard Deviation 33.182
|
|
Percent Change From Baseline in Calcium Phosphorus Product
30 Minutes
|
6.658 percent change
Standard Deviation 13.202
|
2.064 percent change
Standard Deviation 2.420
|
-2.929 percent change
Standard Deviation 14.665
|
2.755 percent change
Standard Deviation 1.384
|
8.239 percent change
Standard Deviation 7.640
|
7.789 percent change
Standard Deviation 10.252
|
|
Percent Change From Baseline in Calcium Phosphorus Product
1 Hour
|
10.828 percent change
Standard Deviation 14.550
|
8.996 percent change
Standard Deviation 4.743
|
-2.861 percent change
Standard Deviation 16.546
|
9.236 percent change
Standard Deviation 4.347
|
6.825 percent change
Standard Deviation 4.170
|
12.464 percent change
Standard Deviation 12.914
|
|
Percent Change From Baseline in Calcium Phosphorus Product
4 Hours
|
34.681 percent change
Standard Deviation 17.635
|
29.766 percent change
Standard Deviation 10.970
|
6.392 percent change
Standard Deviation 6.138
|
21.940 percent change
Standard Deviation 13.151
|
26.340 percent change
Standard Deviation 10.814
|
17.068 percent change
Standard Deviation 5.053
|
|
Percent Change From Baseline in Calcium Phosphorus Product
8 Hours
|
53.138 percent change
Standard Deviation 26.860
|
31.981 percent change
Standard Deviation 22.948
|
-2.240 percent change
Standard Deviation 9.168
|
17.850 percent change
Standard Deviation 11.838
|
23.291 percent change
Standard Deviation 26.675
|
26.854 percent change
Standard Deviation 17.662
|
|
Percent Change From Baseline in Calcium Phosphorus Product
18 Hours
|
75.585 percent change
Standard Deviation 43.897
|
57.263 percent change
Standard Deviation 23.373
|
0.424 percent change
Standard Deviation 6.565
|
17.405 percent change
Standard Deviation 17.156
|
24.889 percent change
Standard Deviation 24.901
|
19.266 percent change
Standard Deviation 24.212
|
|
Percent Change From Baseline in Calcium Phosphorus Product
24 Hours
|
77.196 percent change
Standard Deviation 51.499
|
50.020 percent change
Standard Deviation 23.032
|
-9.383 percent change
Standard Deviation 7.930
|
17.795 percent change
Standard Deviation 29.202
|
14.095 percent change
Standard Deviation 38.924
|
18.115 percent change
Standard Deviation 30.774
|
|
Percent Change From Baseline in Calcium Phosphorus Product
32 Hours
|
87.730 percent change
Standard Deviation 51.888
|
62.691 percent change
Standard Deviation 32.631
|
2.355 percent change
Standard Deviation 8.476
|
16.331 percent change
Standard Deviation 21.671
|
25.814 percent change
Standard Deviation 39.166
|
33.902 percent change
Standard Deviation 27.795
|
|
Percent Change From Baseline in Calcium Phosphorus Product
42 Hours
|
88.570 percent change
Standard Deviation 48.114
|
62.568 percent change
Standard Deviation 28.246
|
5.055 percent change
Standard Deviation 11.224
|
19.449 percent change
Standard Deviation 29.865
|
30.694 percent change
Standard Deviation 30.875
|
25.046 percent change
Standard Deviation 36.401
|
|
Percent Change From Baseline in Calcium Phosphorus Product
48 Hours
|
86.563 percent change
Standard Deviation 54.601
|
60.665 percent change
Standard Deviation 40.658
|
0.863 percent change
Standard Deviation 10.875
|
22.253 percent change
Standard Deviation 33.958
|
32.771 percent change
Standard Deviation 35.019
|
39.450 percent change
Standard Deviation 37.876
|
|
Percent Change From Baseline in Calcium Phosphorus Product
Day 4-Discharge
|
86.989 percent change
Standard Deviation 50.373
|
73.284 percent change
Standard Deviation 46.188
|
13.653 percent change
Standard Deviation 8.448
|
39.885 percent change
Standard Deviation 28.446
|
46.724 percent change
Standard Deviation 26.569
|
36.351 percent change
Standard Deviation 30.774
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).Population: Participants who were randomized and received any amount of etelcalcetide.
Outcome measures
| Measure |
Pooled Placebo
n=4 Participants
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=3 Participants
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=4 Participants
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
n=4 Participants
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=4 Participants
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
|
145 μg/L
Standard Deviation 64.8
|
263 μg/L
Standard Deviation 67.2
|
511 μg/L
Standard Deviation 230
|
726 μg/L
Standard Deviation 278
|
1140 μg/L
Standard Deviation 428
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).Population: Participants who were randomized and received any amount of etelcalcetide with available data.
Outcome measures
| Measure |
Pooled Placebo
n=4 Participants
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=3 Participants
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=4 Participants
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
n=3 Participants
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=4 Participants
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide
|
1110 hr*μg/L
Standard Deviation 182
|
2820 hr*μg/L
Standard Deviation 458
|
4920 hr*μg/L
Standard Deviation 1650
|
9560 hr*μg/L
Standard Deviation 3340
|
15700 hr*μg/L
Standard Deviation 5100
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).Population: Participants who were randomized and received any amount of etelcalcetide and with available data; The half-life associated with the terminal (log-linear) elimination phase values for the 40 mg dose level were not calculated due to poor log linear regression of the log concentration versus time profile during the terminal phase (r2 values \<0.7).
Outcome measures
| Measure |
Pooled Placebo
n=3 Participants
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=2 Participants
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=2 Participants
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=3 Participants
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
|
3180 hr*μg/L
Standard Deviation 1350
|
5280 hr*μg/L
Standard Deviation 970
|
16800 hr*μg/L
Standard Deviation 4560
|
—
|
43800 hr*μg/L
Standard Deviation 16900
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).Population: Participants who were randomized and received any amount of etelcalcetide and with available data.
Outcome measures
| Measure |
Pooled Placebo
n=3 Participants
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=2 Participants
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=4 Participants
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
n=3 Participants
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=4 Participants
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide
|
64.6 percentage of AUCINF
Standard Deviation 11.4
|
50.9 percentage of AUCINF
Standard Deviation 9.55
|
71.7 percentage of AUCINF
Standard Deviation 5.96
|
60.2 percentage of AUCINF
Standard Deviation 25.8
|
68.0 percentage of AUCINF
Standard Deviation 8.24
|
—
|
Adverse Events
Pooled Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Etelcalcetide 5 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Etelcalcetide 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Etelcalcetide 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Etelcalcetide 40 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Etelcalcetide 60 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pooled Placebo
n=20 participants at risk
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=4 participants at risk
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=3 participants at risk
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
n=4 participants at risk
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=4 participants at risk
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
n=4 participants at risk
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
5.0%
1/20 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Pooled Placebo
n=20 participants at risk
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
|
Etelcalcetide 5 mg
n=4 participants at risk
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 10 mg
n=3 participants at risk
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 20 mg
n=4 participants at risk
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 40 mg
n=4 participants at risk
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
|
Etelcalcetide 60 mg
n=4 participants at risk
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/20 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/20 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
INJECTION SITE PRURITUS
|
0.00%
0/20 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
CALCIUM IONISED DECREASED
|
0.00%
0/20 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
100.0%
4/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
2/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
PARAESTHESIA
|
5.0%
1/20 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
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