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Trial record 80 of 108 for:    CALCIUM CATION

Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

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ClinicalTrials.gov Identifier: NCT01134562
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
KAI Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hyperparathyroidism, Secondary
Interventions Drug: Placebo
Drug: Etelcalcetide
Enrollment 28
Recruitment Details This study was conducted at 1 center in Australia and 2 centers in the United States from 07 September 2010 to 02 April 2011.
Pre-assignment Details 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.
Arm/Group Title Cohort 1: Placebo/Etelcalcetide 5 mg Cohort 2: Placebo/Etelcalcetide 10 mg Cohort 3: Placebo/Etelcalcetide 20 mg Cohort 4: Placebo/Etelcalcetide 40 mg Cohort 5: Placebo/Etelcalcetide 60 mg
Hide Arm/Group Description Participants in Cohort 1 received single doses of 5 mg etelcalcetide and placebo in a crossover design, 7-14 days apart Participants in Cohort 2 received single doses of 10 mg etelcalcetide and placebo in a crossover design, 7-14 days apart Participants in Cohort 3 received single doses of 20 mg etelcalcetide and placebo in a crossover design, 7-14 days apart Participants in Cohort 4 received a single dose of 40 mg etelcalcetide or placebo in a parallel group design. Participants in Cohort 5 received a single dose of 60 mg etelcalcetide or placebo in a parallel group design.
Period Title: Overall Study
Started 4 4 4 8 8
Completed 4 3 4 8 8
Not Completed 0 1 0 0 0
Reason Not Completed
Adverse Event             0             1             0             0             0
Arm/Group Title Cohort 1: Placebo/Etelcalcetide 5 mg Cohort 2: Placebo/Etelcalcetide 10 mg Cohort 3: Placebo/Etelcalcetide 20 mg Cohort 4: Placebo/Etelcalcetide 40 mg Cohort 5: Placebo/Etelcalcetide 60 mg Total
Hide Arm/Group Description Participants in Cohort 1 received single doses of 5 mg etelcalcetide and placebo in a crossover design, 7-14 days apart Participants in Cohort 2 received single doses of 10 mg etelcalcetide and placebo in a crossover design, 7-14 days apart Participants in Cohort 3 received single doses of 20 mg etelcalcetide and placebo in a crossover design, 7-14 days apart Participants in Cohort 4 received a single dose of 40 mg etelcalcetide or placebo in a parallel group design. Participants in Cohort 5 received a single dose of 60 mg etelcalcetide or placebo in a parallel group design. Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 8 8 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 4 participants 8 participants 8 participants 28 participants
54.3  (10.4) 59.0  (14.5) 52.8  (21.2) 52.9  (14.6) 47.5  (10.9) 52.4  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 8 participants 8 participants 28 participants
Female
1
  25.0%
0
   0.0%
1
  25.0%
4
  50.0%
2
  25.0%
8
  28.6%
Male
3
  75.0%
4
 100.0%
3
  75.0%
4
  50.0%
6
  75.0%
20
  71.4%
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 8 participants 8 participants 28 participants
White
1
  25.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
  12.5%
3
  10.7%
African American
2
  50.0%
4
 100.0%
3
  75.0%
8
 100.0%
7
  87.5%
24
  85.7%
Asian
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.6%
Ethnicity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 8 participants 8 participants 28 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Non-Hispanic or Latino
4
 100.0%
4
 100.0%
4
 100.0%
8
 100.0%
8
 100.0%
28
 100.0%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received any amount of study medication.
Arm/Group Title Pooled Placebo Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Hide Arm/Group Description:
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
Overall Number of Participants Analyzed 20 4 3 4 4 4
Measure Type: Number
Unit of Measure: participants
Any adverse events 2 1 1 1 4 2
Serious adverse events 1 0 0 0 0 0
Withdrawal due to adverse events 1 0 0 0 0 0
Deaths due to adverse events 0 0 0 0 0 0
Treatment-related adverse events 1 1 1 0 4 2
2.Secondary Outcome
Title Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
Hide Description [Not Specified]
Time Frame 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 29
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pooled Placebo Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Hide Arm/Group Description:
Participants received a single dose of placebo IV injection after hemodialysis.
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
Overall Number of Participants Analyzed 20 4 3 4 4 4
Mean (Standard Deviation)
Unit of Measure: percent change
30 Minutes Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
1.381  (20.429) -63.179  (5.135) -68.890  (9.616) -70.021  (11.273) -72.435  (11.176) -77.471  (5.979)
1 Hour Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
-0.540  (17.092) -64.094  (4.547) -73.060  (7.959) -70.309  (9.601) -75.898  (11.333) -78.757  (4.921)
4 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
3.922  (30.491) -39.975  (14.961) -51.734  (23.294) -72.893  (14.821) -74.627  (13.479) -80.266  (7.476)
8 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
4.014  (25.061) -39.789  (9.694) -52.075  (16.841) -70.904  (15.663) -77.031  (8.236) -84.184  (6.461)
18 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
-13.552  (25.000) -23.751  (10.615) -48.744  (15.460) -72.653  (16.154) -78.332  (7.393) -85.547  (6.056)
24 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
-16.888  (30.497) -23.420  (10.289) -46.642  (18.136) -41.723  (26.353) -77.206  (4.005) -84.845  (6.208)
32 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
-16.434  (34.774) -18.406  (15.484) -32.987  (26.492) -55.919  (33.153) -69.795  (4.812) -83.439  (5.802)
42 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
-20.394  (25.119) -9.087  (10.439) -34.912  (22.835) -57.207  (32.894) -63.258  (5.239) -76.096  (9.079)
48 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
-21.664  (28.956) -14.905  (16.588) -36.142  (24.957) -43.145  (43.175) -55.486  (1.761) -71.268  (11.557)
56 Hours Number Analyzed 20 participants 3 participants 3 participants 4 participants 4 participants 4 participants
-15.484  (33.626) -2.968  (20.870) -21.994  (34.015) -43.271  (44.442) -48.128  (3.740) -60.112  (16.074)
Day 4-Discharge Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
-11.192  (33.131) -7.428  (15.016) 13.264  (23.682) -48.533  (32.739) -49.277  (6.274) -62.628  (12.335)
Day 8 Number Analyzed 8 participants 0 participants 0 participants 0 participants 4 participants 4 participants
-31.881  (38.536) -30.766  (32.248) -61.093  (5.804)
Day 15 Number Analyzed 8 participants 0 participants 0 participants 0 participants 4 participants 4 participants
-33.993  (44.928) -34.149  (22.536) -58.510  (15.169)
Day 29 Number Analyzed 8 participants 0 participants 0 participants 0 participants 4 participants 4 participants
-31.394  (47.249) -14.750  (28.303) -44.478  (16.631)
3.Secondary Outcome
Title Percent Change From Baseline in Serum Corrected Calcium
Hide Description [Not Specified]
Time Frame 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 29
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pooled Placebo Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Hide Arm/Group Description:
Participants received a single dose of placebo IV injection after hemodialysis.
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
Overall Number of Participants Analyzed 20 4 3 4 4 4
Mean (Standard Deviation)
Unit of Measure: percent change
30 Minutes Number Analyzed 19 participants 4 participants 3 participants 4 participants 4 participants 4 participants
0.024  (3.881) 0.106  (4.550) -2.883  (2.457) -2.589  (1.665) -0.572  (2.126) 1.951  (6.723)
1 Hour Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
-0.295  (4.644) 0.256  (1.043) -5.176  (2.874) -2.574  (1.335) -3.700  (3.395) 3.445  (9.876)
4 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
0.540  (4.998) -3.427  (1.201) -7.795  (2.473) -5.515  (1.939) -3.599  (2.991) -1.258  (10.241)
8 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
0.945  (5.894) -5.533  (8.724) -10.697  (4.257) -7.685  (2.633) -5.895  (5.393) -4.057  (10.732)
18 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
3.669  (7.885) -3.103  (3.399) -8.018  (6.150) -9.560  (4.703) -5.993  (9.270) -5.738  (10.402)
24 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
3.853  (8.667) -3.003  (4.149) -8.826  (2.766) -11.436  (5.463) -8.436  (10.582) -5.688  (9.762)
32 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
3.079  (9.187) -1.632  (7.315) -9.436  (2.192) -10.644  (8.525) -6.155  (12.748) -7.146  (10.382)
42 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
3.209  (9.716) -4.815  (8.629) -9.049  (3.745) -11.700  (8.151) -9.186  (8.793) -9.082  (7.392)
48 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
2.918  (8.965) -2.781  (7.855) -9.115  (0.280) -9.458  (7.873) -8.174  (9.005) -10.911  (9.479)
56 Hours Number Analyzed 20 participants 3 participants 3 participants 4 participants 4 participants 4 participants
1.920  (10.339) -1.583  (4.258) -10.338  (4.119) -9.227  (6.946) -8.970  (8.789) -12.300  (9.491)
Day 4-Discharge Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
1.556  (10.240) -2.577  (12.131) -7.405  (4.208) -9.200  (6.760) -8.180  (9.334) -13.186  (9.781)
Day 8 Number Analyzed 8 participants 0 participants 0 participants 0 participants 4 participants 4 participants
0.632  (10.506) -3.985  (12.631) -8.859  (3.740)
Day 15 Number Analyzed 8 participants 0 participants 0 participants 0 participants 4 participants 4 participants
3.827  (8.196) -0.238  (8.371) -6.885  (9.669)
Day 29 Number Analyzed 8 participants 0 participants 0 participants 0 participants 4 participants 4 participants
4.228  (9.346) 2.221  (2.378) 3.620  (7.196)
4.Secondary Outcome
Title Percent Change From Baseline in Ionized Calcium
Hide Description [Not Specified]
Time Frame Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received any amount of study medication with available data at each time point
Arm/Group Title Pooled Placebo Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Hide Arm/Group Description:
Participants received a single dose of placebo IV injection after hemodialysis.
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
Overall Number of Participants Analyzed 20 4 3 4 4 3
Mean (Standard Deviation)
Unit of Measure: percent change
30 Minutes Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 3 participants
-0.118  (2.920) 0.234  (2.172) -2.940  (4.619) -0.122  (2.400) -0.934  (2.007) -3.300  (5.716)
1 Hour Number Analyzed 20 participants 4 participants 3 participants 4 participants 3 participants 3 participants
-0.151  (2.577) -1.406  (3.173) -1.394  (3.841) -0.442  (4.233) -3.072  (7.850) 1.595  (1.118)
4 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 3 participants
0.744  (3.126) -3.436  (4.124) -6.015  (1.847) -3.550  (4.054) -3.759  (11.275) -1.514  (3.049)
8 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 3 participants
1.924  (4.128) -0.703  (4.896) -6.218  (2.395) -7.160  (6.947) -3.867  (10.572) -8.652  (3.231)
18 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 3 participants
6.570  (5.729) -2.168  (4.508) -4.125  (3.667) -6.571  (5.425) -3.949  (5.644) -12.139  (5.122)
24 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 3 participants
6.920  (6.835) -0.663  (3.640) -3.822  (3.953) -7.093  (8.308) -5.395  (11.404) -10.916  (4.793)
32 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 3 participants
5.925  (7.251) 0.918  (3.431) -2.830  (5.873) -4.044  (11.718) -5.090  (10.317) -7.627  (2.563)
42 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 3 participants
8.157  (8.080) -0.456  (3.392) -4.213  (1.195) -5.980  (8.479) -3.212  (6.593) -12.00  (3.337)
48 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 3 participants
6.080  (8.323) -1.376  (4.136) -2.919  (3.392) -5.282  (9.031) -2.468  (9.489) -13.449  (3.961)
56 Hours Number Analyzed 20 participants 3 participants 3 participants 4 participants 4 participants 3 participants
5.991  (7.704) 0.612  (5.530) -3.780  (4.981) -3.766  (9.005) -3.052  (8.958) -11.229  (4.218)
Day 4-Discharge Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 3 participants
6.152  (8.162) 2.765  (4.557) -1.697  (4.582) -1.174  (9.134) 1.601  (12.279) -12.798  (3.424)
5.Secondary Outcome
Title Percent Change From Baseline in Serum Phosphorus
Hide Description [Not Specified]
Time Frame Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received any amount of study medication with available data at each time point.
Arm/Group Title Pooled Placebo Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Hide Arm/Group Description:
Participants received a single dose of placebo IV injection after hemodialysis.
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
Overall Number of Participants Analyzed 20 4 3 4 4 4
Mean (Standard Deviation)
Unit of Measure: percent change
30 Minutes Number Analyzed 19 participants 4 participants 3 participants 4 participants 4 participants 4 participants
6.453  (10.400) 2.080  (4.235) -0.255  (12.843) 5.498  (1.546) 9.024  (10.125) 5.608  (4.474)
1 Hour Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
10.907  (10.912) 8.750  (5.519) 2.219  (15.246) 12.164  (5.483) 11.018  (5.492) 8.621  (4.780)
4 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
34.009  (16.904) 34.441  (12.211) 15.334  (4.080) 29.231  (15.513) 30.927  (8.124) 19.261  (9.807)
8 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
51.998  (27.762) 41.575  (33.433) 9.325  (5.563) 27.684  (12.520) 30.640  (24.248) 32.465  (15.418)
18 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
69.207  (41.794) 62.681  (26.476) 9.206  (2.538) 30.352  (22.143) 32.018  (14.688) 26.240  (19.622)
24 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
69.676  (45.038) 55.497  (29.444) -0.574  (8.659) 32.376  (28.527) 24.240  (37.457) 24.655  (27.651)
32 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
81.616  (48.245) 67.662  (43.365) 12.914  (6.547) 29.678  (15.174) 32.705  (28.481) 43.411  (19.010)
42 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
82.478  (44.276) 72.340  (35.380) 15.357  (8.616) 35.259  (31.535) 43.149  (25.219) 36.299  (31.742)
48 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
80.245  (48.363) 66.536  (45.455) 10.970  (11.808) 34.452  (31.330) 43.624  (29.435) 55.718  (35.112)
56 Hours Number Analyzed 20 participants 3 participants 3 participants 4 participants 4 participants 4 participants
83.741  (51.885) 98.775  (67.669) 17.867  (18.308) 35.569  (21.851) 43.033  (33.634) 63.990  (28.031)
Day 4-Discharge Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
83.535  (44.193) 78.775  (45.141) 23.022  (12.403) 54.242  (30.386) 59.563  (19.668) 56.708  (29.407)
6.Secondary Outcome
Title Percent Change From Baseline in Calcium Phosphorus Product
Hide Description [Not Specified]
Time Frame Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received any amount of study medication with available data at each time point.
Arm/Group Title Pooled Placebo Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Hide Arm/Group Description:
Participants received a single dose of placebo IV injection after hemodialysis.
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
Overall Number of Participants Analyzed 20 4 3 4 4 4
Mean (Standard Deviation)
Unit of Measure: percent change
30 Minutes Number Analyzed 19 participants 4 participants 3 participants 4 participants 4 participants 4 participants
6.658  (13.202) 2.064  (2.420) -2.929  (14.665) 2.755  (1.384) 8.239  (7.640) 7.789  (10.252)
1 Hour Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
10.828  (14.550) 8.996  (4.743) -2.861  (16.546) 9.236  (4.347) 6.825  (4.170) 12.464  (12.914)
4 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
34.681  (17.635) 29.766  (10.970) 6.392  (6.138) 21.940  (13.151) 26.340  (10.814) 17.068  (5.053)
8 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
53.138  (26.860) 31.981  (22.948) -2.240  (9.168) 17.850  (11.838) 23.291  (26.675) 26.854  (17.662)
18 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
75.585  (43.897) 57.263  (23.373) 0.424  (6.565) 17.405  (17.156) 24.889  (24.901) 19.266  (24.212)
24 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
77.196  (51.499) 50.020  (23.032) -9.383  (7.930) 17.795  (29.202) 14.095  (38.924) 18.115  (30.774)
32 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
87.730  (51.888) 62.691  (32.631) 2.355  (8.476) 16.331  (21.671) 25.814  (39.166) 33.902  (27.795)
42 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
88.570  (48.114) 62.568  (28.246) 5.055  (11.224) 19.449  (29.865) 30.694  (30.875) 25.046  (36.401)
48 Hours Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
86.563  (54.601) 60.665  (40.658) 0.863  (10.875) 22.253  (33.958) 32.771  (35.019) 39.450  (37.876)
56 Hours Number Analyzed 20 participants 3 participants 3 participants 4 participants 4 participants 4 participants
88.531  (59.100) 93.793  (59.933) 5.483  (15.538) 23.351  (25.107) 31.825  (42.108) 44.582  (33.182)
Day 4-Discharge Number Analyzed 20 participants 4 participants 3 participants 4 participants 4 participants 4 participants
86.989  (50.373) 73.284  (46.188) 13.653  (8.448) 39.885  (28.446) 46.724  (26.569) 36.351  (30.774)
7.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
Hide Description [Not Specified]
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received any amount of etelcalcetide.
Arm/Group Title Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Hide Arm/Group Description:
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
Overall Number of Participants Analyzed 4 3 4 4 4
Mean (Standard Deviation)
Unit of Measure: μg/L
145  (64.8) 263  (67.2) 511  (230) 726  (278) 1140  (428)
8.Secondary Outcome
Title Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide
Hide Description [Not Specified]
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received any amount of etelcalcetide with available data.
Arm/Group Title Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Hide Arm/Group Description:
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
Overall Number of Participants Analyzed 4 3 4 3 4
Mean (Standard Deviation)
Unit of Measure: hr*μg/L
1110  (182) 2820  (458) 4920  (1650) 9560  (3340) 15700  (5100)
9.Secondary Outcome
Title Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
Hide Description [Not Specified]
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Hide Arm/Group Description:
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
Overall Number of Participants Analyzed 3 2 2 0 3
Mean (Standard Deviation)
Unit of Measure: hr*μg/L
3180  (1350) 5280  (970) 16800  (4560) 43800  (16900)
10.Secondary Outcome
Title Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide
Hide Description [Not Specified]
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received any amount of etelcalcetide and with available data.
Arm/Group Title Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Hide Arm/Group Description:
Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.
Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
Overall Number of Participants Analyzed 3 2 4 3 4
Mean (Standard Deviation)
Unit of Measure: percentage of AUCINF
64.6  (11.4) 50.9  (9.55) 71.7  (5.96) 60.2  (25.8) 68.0  (8.24)
Time Frame 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.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Pooled Placebo Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Hide Arm/Group Description Participants received a single dose of placebo intravenous (IV) injection after hemodialysis. Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis. Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis. Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis. Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis. Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.
All-Cause Mortality
Pooled Placebo Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pooled Placebo Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/20 (5.00%)   0/4 (0.00%)   0/3 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Cardiac disorders             
CARDIAC FAILURE CONGESTIVE  1  1/20 (5.00%)  0/4 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pooled Placebo Etelcalcetide 5 mg Etelcalcetide 10 mg Etelcalcetide 20 mg Etelcalcetide 40 mg Etelcalcetide 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/20 (5.00%)   1/4 (25.00%)   1/3 (33.33%)   1/4 (25.00%)   4/4 (100.00%)   2/4 (50.00%) 
Gastrointestinal disorders             
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/20 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
TOOTHACHE  1  0/20 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%) 
General disorders             
INJECTION SITE PRURITUS  1  0/20 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Investigations             
CALCIUM IONISED DECREASED  1  0/20 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  4/4 (100.00%)  2/4 (50.00%) 
Nervous system disorders             
PARAESTHESIA  1  1/20 (5.00%)  1/4 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen, Inc
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01134562     History of Changes
Other Study ID Numbers: KAI-4169-002
20130139 ( Other Identifier: Amgen, Inc )
First Submitted: May 28, 2010
First Posted: June 2, 2010
Results First Submitted: March 1, 2017
Results First Posted: January 2, 2018
Last Update Posted: January 2, 2018