NCT01134562 is a Phase 1 clinical trial of Etelcalcetide in Hyperparathyroidism, Secondary, sponsored by KAI Pharmaceuticals.

Who is sponsoring NCT01134562?

NCT01134562 is sponsored by KAI Pharmaceuticals.

What drugs are being tested in NCT01134562?

Interventions in NCT01134562: Placebo, Etelcalcetide.

What condition does NCT01134562 study?

NCT01134562 studies Hyperparathyroidism, Secondary.

Is NCT01134562 still recruiting?

NCT01134562 is currently completed. Last updated 2 January 2018.

Are results published for NCT01134562?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-01-02 · How we verify

NCT01134562

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 2 January 2018

What this trial tests

Phase 1 trial testing Placebo in Hyperparathyroidism, Secondary in 28 participants. Completed in 2 April 2011.

Timeline

7 September 2010

Primary endpoint
2 April 2011

2 April 2011

Quick facts

Lead sponsor	KAI Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	28
Start date	7 September 2010
Primary completion	2 April 2011
Estimated completion	2 April 2011
Sites	5 locations across United States, Australia

Drugs / interventions tested

Placebo
Etelcalcetide (ETELCALCETIDE) — full drug profile →

Conditions studied

Hyperparathyroidism, Secondary — all drugs for Hyperparathyroidism, Secondary →

Sponsor

KAI Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Hyperparathyroidism, Secondary. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · 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.

Any adverse events

Group	Value	95% CI
Pooled Placebo	2
Etelcalcetide 5 mg	1
Etelcalcetide 10 mg	1
Etelcalcetide 20 mg	1
Etelcalcetide 40 mg	4
Etelcalcetide 60 mg	2

Serious adverse events

Group	Value	95% CI
Pooled Placebo	1
Etelcalcetide 5 mg	0
Etelcalcetide 10 mg	0
Etelcalcetide 20 mg	0
Etelcalcetide 40 mg	0
Etelcalcetide 60 mg	0

Withdrawal due to adverse events

Group	Value	95% CI
Pooled Placebo	1
Etelcalcetide 5 mg	0
Etelcalcetide 10 mg	0
Etelcalcetide 20 mg	0
Etelcalcetide 40 mg	0
Etelcalcetide 60 mg	0

Deaths due to adverse events

Group	Value	95% CI
Pooled Placebo	0
Etelcalcetide 5 mg	0
Etelcalcetide 10 mg	0
Etelcalcetide 20 mg	0
Etelcalcetide 40 mg	0
Etelcalcetide 60 mg	0

Treatment-related adverse events

Group	Value	95% CI
Pooled Placebo	1
Etelcalcetide 5 mg	1
Etelcalcetide 10 mg	1
Etelcalcetide 20 mg	0
Etelcalcetide 40 mg	4
Etelcalcetide 60 mg	2

Percent Change From Baseline in Serum Parathyroid Hormone (PTH) Secondary · 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

30 Minutes

Group	Value	95% CI
Pooled Placebo	1.381	± 20.429
Etelcalcetide 5 mg	-63.179	± 5.135
Etelcalcetide 10 mg	-68.890	± 9.616
Etelcalcetide 20 mg	-70.021	± 11.273
Etelcalcetide 40 mg	-72.435	± 11.176
Etelcalcetide 60 mg	-77.471	± 5.979

1 Hour

Group	Value	95% CI
Pooled Placebo	-0.540	± 17.092
Etelcalcetide 5 mg	-64.094	± 4.547
Etelcalcetide 10 mg	-73.060	± 7.959
Etelcalcetide 20 mg	-70.309	± 9.601
Etelcalcetide 40 mg	-75.898	± 11.333
Etelcalcetide 60 mg	-78.757	± 4.921

4 Hours

Group	Value	95% CI
Pooled Placebo	3.922	± 30.491
Etelcalcetide 5 mg	-39.975	± 14.961
Etelcalcetide 10 mg	-51.734	± 23.294
Etelcalcetide 20 mg	-72.893	± 14.821
Etelcalcetide 40 mg	-74.627	± 13.479
Etelcalcetide 60 mg	-80.266	± 7.476

8 Hours

Group	Value	95% CI
Pooled Placebo	4.014	± 25.061
Etelcalcetide 5 mg	-39.789	± 9.694
Etelcalcetide 10 mg	-52.075	± 16.841
Etelcalcetide 20 mg	-70.904	± 15.663
Etelcalcetide 40 mg	-77.031	± 8.236
Etelcalcetide 60 mg	-84.184	± 6.461

18 Hours

Group	Value	95% CI
Pooled Placebo	-13.552	± 25.000
Etelcalcetide 5 mg	-23.751	± 10.615
Etelcalcetide 10 mg	-48.744	± 15.460
Etelcalcetide 20 mg	-72.653	± 16.154
Etelcalcetide 40 mg	-78.332	± 7.393
Etelcalcetide 60 mg	-85.547	± 6.056

24 Hours

Group	Value	95% CI
Pooled Placebo	-16.888	± 30.497
Etelcalcetide 5 mg	-23.420	± 10.289
Etelcalcetide 10 mg	-46.642	± 18.136
Etelcalcetide 20 mg	-41.723	± 26.353
Etelcalcetide 40 mg	-77.206	± 4.005
Etelcalcetide 60 mg	-84.845	± 6.208

32 Hours

Group	Value	95% CI
Pooled Placebo	-16.434	± 34.774
Etelcalcetide 5 mg	-18.406	± 15.484
Etelcalcetide 10 mg	-32.987	± 26.492
Etelcalcetide 20 mg	-55.919	± 33.153
Etelcalcetide 40 mg	-69.795	± 4.812
Etelcalcetide 60 mg	-83.439	± 5.802

42 Hours

Group	Value	95% CI
Pooled Placebo	-20.394	± 25.119
Etelcalcetide 5 mg	-9.087	± 10.439
Etelcalcetide 10 mg	-34.912	± 22.835
Etelcalcetide 20 mg	-57.207	± 32.894
Etelcalcetide 40 mg	-63.258	± 5.239
Etelcalcetide 60 mg	-76.096	± 9.079

Percent Change From Baseline in Serum Corrected Calcium Secondary · 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

30 Minutes

Group	Value	95% CI
Pooled Placebo	0.024	± 3.881
Etelcalcetide 5 mg	0.106	± 4.550
Etelcalcetide 10 mg	-2.883	± 2.457
Etelcalcetide 20 mg	-2.589	± 1.665
Etelcalcetide 40 mg	-0.572	± 2.126
Etelcalcetide 60 mg	1.951	± 6.723

1 Hour

Group	Value	95% CI
Pooled Placebo	-0.295	± 4.644
Etelcalcetide 5 mg	0.256	± 1.043
Etelcalcetide 10 mg	-5.176	± 2.874
Etelcalcetide 20 mg	-2.574	± 1.335
Etelcalcetide 40 mg	-3.700	± 3.395
Etelcalcetide 60 mg	3.445	± 9.876

4 Hours

Group	Value	95% CI
Pooled Placebo	0.540	± 4.998
Etelcalcetide 5 mg	-3.427	± 1.201
Etelcalcetide 10 mg	-7.795	± 2.473
Etelcalcetide 20 mg	-5.515	± 1.939
Etelcalcetide 40 mg	-3.599	± 2.991
Etelcalcetide 60 mg	-1.258	± 10.241

8 Hours

Group	Value	95% CI
Pooled Placebo	0.945	± 5.894
Etelcalcetide 5 mg	-5.533	± 8.724
Etelcalcetide 10 mg	-10.697	± 4.257
Etelcalcetide 20 mg	-7.685	± 2.633
Etelcalcetide 40 mg	-5.895	± 5.393
Etelcalcetide 60 mg	-4.057	± 10.732

18 Hours

Group	Value	95% CI
Pooled Placebo	3.669	± 7.885
Etelcalcetide 5 mg	-3.103	± 3.399
Etelcalcetide 10 mg	-8.018	± 6.150
Etelcalcetide 20 mg	-9.560	± 4.703
Etelcalcetide 40 mg	-5.993	± 9.270
Etelcalcetide 60 mg	-5.738	± 10.402

24 Hours

Group	Value	95% CI
Pooled Placebo	3.853	± 8.667
Etelcalcetide 5 mg	-3.003	± 4.149
Etelcalcetide 10 mg	-8.826	± 2.766
Etelcalcetide 20 mg	-11.436	± 5.463
Etelcalcetide 40 mg	-8.436	± 10.582
Etelcalcetide 60 mg	-5.688	± 9.762

32 Hours

Group	Value	95% CI
Pooled Placebo	3.079	± 9.187
Etelcalcetide 5 mg	-1.632	± 7.315
Etelcalcetide 10 mg	-9.436	± 2.192
Etelcalcetide 20 mg	-10.644	± 8.525
Etelcalcetide 40 mg	-6.155	± 12.748
Etelcalcetide 60 mg	-7.146	± 10.382

42 Hours

Group	Value	95% CI
Pooled Placebo	3.209	± 9.716
Etelcalcetide 5 mg	-4.815	± 8.629
Etelcalcetide 10 mg	-9.049	± 3.745
Etelcalcetide 20 mg	-11.700	± 8.151
Etelcalcetide 40 mg	-9.186	± 8.793
Etelcalcetide 60 mg	-9.082	± 7.392

Percent Change From Baseline in Ionized Calcium Secondary · Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).

30 Minutes

Group	Value	95% CI
Pooled Placebo	-0.118	± 2.920
Etelcalcetide 5 mg	0.234	± 2.172
Etelcalcetide 10 mg	-2.940	± 4.619
Etelcalcetide 20 mg	-0.122	± 2.400
Etelcalcetide 40 mg	-0.934	± 2.007
Etelcalcetide 60 mg	-3.300	± 5.716

1 Hour

Group	Value	95% CI
Pooled Placebo	-0.151	± 2.577
Etelcalcetide 5 mg	-1.406	± 3.173
Etelcalcetide 10 mg	-1.394	± 3.841
Etelcalcetide 20 mg	-0.442	± 4.233
Etelcalcetide 40 mg	-3.072	± 7.850
Etelcalcetide 60 mg	1.595	± 1.118

4 Hours

Group	Value	95% CI
Pooled Placebo	0.744	± 3.126
Etelcalcetide 5 mg	-3.436	± 4.124
Etelcalcetide 10 mg	-6.015	± 1.847
Etelcalcetide 20 mg	-3.550	± 4.054
Etelcalcetide 40 mg	-3.759	± 11.275
Etelcalcetide 60 mg	-1.514	± 3.049

8 Hours

Group	Value	95% CI
Pooled Placebo	1.924	± 4.128
Etelcalcetide 5 mg	-0.703	± 4.896
Etelcalcetide 10 mg	-6.218	± 2.395
Etelcalcetide 20 mg	-7.160	± 6.947
Etelcalcetide 40 mg	-3.867	± 10.572
Etelcalcetide 60 mg	-8.652	± 3.231

18 Hours

Group	Value	95% CI
Pooled Placebo	6.570	± 5.729
Etelcalcetide 5 mg	-2.168	± 4.508
Etelcalcetide 10 mg	-4.125	± 3.667
Etelcalcetide 20 mg	-6.571	± 5.425
Etelcalcetide 40 mg	-3.949	± 5.644
Etelcalcetide 60 mg	-12.139	± 5.122

24 Hours

Group	Value	95% CI
Pooled Placebo	6.920	± 6.835
Etelcalcetide 5 mg	-0.663	± 3.640
Etelcalcetide 10 mg	-3.822	± 3.953
Etelcalcetide 20 mg	-7.093	± 8.308
Etelcalcetide 40 mg	-5.395	± 11.404
Etelcalcetide 60 mg	-10.916	± 4.793

32 Hours

Group	Value	95% CI
Pooled Placebo	5.925	± 7.251
Etelcalcetide 5 mg	0.918	± 3.431
Etelcalcetide 10 mg	-2.830	± 5.873
Etelcalcetide 20 mg	-4.044	± 11.718
Etelcalcetide 40 mg	-5.090	± 10.317
Etelcalcetide 60 mg	-7.627	± 2.563

42 Hours

Group	Value	95% CI
Pooled Placebo	8.157	± 8.080
Etelcalcetide 5 mg	-0.456	± 3.392
Etelcalcetide 10 mg	-4.213	± 1.195
Etelcalcetide 20 mg	-5.980	± 8.479
Etelcalcetide 40 mg	-3.212	± 6.593
Etelcalcetide 60 mg	-12.00	± 3.337

Percent Change From Baseline in Serum Phosphorus Secondary · Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).

30 Minutes

Group	Value	95% CI
Pooled Placebo	6.453	± 10.400
Etelcalcetide 5 mg	2.080	± 4.235
Etelcalcetide 10 mg	-0.255	± 12.843
Etelcalcetide 20 mg	5.498	± 1.546
Etelcalcetide 40 mg	9.024	± 10.125
Etelcalcetide 60 mg	5.608	± 4.474

1 Hour

Group	Value	95% CI
Pooled Placebo	10.907	± 10.912
Etelcalcetide 5 mg	8.750	± 5.519
Etelcalcetide 10 mg	2.219	± 15.246
Etelcalcetide 20 mg	12.164	± 5.483
Etelcalcetide 40 mg	11.018	± 5.492
Etelcalcetide 60 mg	8.621	± 4.780

4 Hours

Group	Value	95% CI
Pooled Placebo	34.009	± 16.904
Etelcalcetide 5 mg	34.441	± 12.211
Etelcalcetide 10 mg	15.334	± 4.080
Etelcalcetide 20 mg	29.231	± 15.513
Etelcalcetide 40 mg	30.927	± 8.124
Etelcalcetide 60 mg	19.261	± 9.807

8 Hours

Group	Value	95% CI
Pooled Placebo	51.998	± 27.762
Etelcalcetide 5 mg	41.575	± 33.433
Etelcalcetide 10 mg	9.325	± 5.563
Etelcalcetide 20 mg	27.684	± 12.520
Etelcalcetide 40 mg	30.640	± 24.248
Etelcalcetide 60 mg	32.465	± 15.418

18 Hours

Group	Value	95% CI
Pooled Placebo	69.207	± 41.794
Etelcalcetide 5 mg	62.681	± 26.476
Etelcalcetide 10 mg	9.206	± 2.538
Etelcalcetide 20 mg	30.352	± 22.143
Etelcalcetide 40 mg	32.018	± 14.688
Etelcalcetide 60 mg	26.240	± 19.622

24 Hours

Group	Value	95% CI
Pooled Placebo	69.676	± 45.038
Etelcalcetide 5 mg	55.497	± 29.444
Etelcalcetide 10 mg	-0.574	± 8.659
Etelcalcetide 20 mg	32.376	± 28.527
Etelcalcetide 40 mg	24.240	± 37.457
Etelcalcetide 60 mg	24.655	± 27.651

32 Hours

Group	Value	95% CI
Pooled Placebo	81.616	± 48.245
Etelcalcetide 5 mg	67.662	± 43.365
Etelcalcetide 10 mg	12.914	± 6.547
Etelcalcetide 20 mg	29.678	± 15.174
Etelcalcetide 40 mg	32.705	± 28.481
Etelcalcetide 60 mg	43.411	± 19.010

42 Hours

Group	Value	95% CI
Pooled Placebo	82.478	± 44.276
Etelcalcetide 5 mg	72.340	± 35.380
Etelcalcetide 10 mg	15.357	± 8.616
Etelcalcetide 20 mg	35.259	± 31.535
Etelcalcetide 40 mg	43.149	± 25.219
Etelcalcetide 60 mg	36.299	± 31.742

Percent Change From Baseline in Calcium Phosphorus Product Secondary · Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).

30 Minutes

Group	Value	95% CI
Pooled Placebo	6.658	± 13.202
Etelcalcetide 5 mg	2.064	± 2.420
Etelcalcetide 10 mg	-2.929	± 14.665
Etelcalcetide 20 mg	2.755	± 1.384
Etelcalcetide 40 mg	8.239	± 7.640
Etelcalcetide 60 mg	7.789	± 10.252

1 Hour

Group	Value	95% CI
Pooled Placebo	10.828	± 14.550
Etelcalcetide 5 mg	8.996	± 4.743
Etelcalcetide 10 mg	-2.861	± 16.546
Etelcalcetide 20 mg	9.236	± 4.347
Etelcalcetide 40 mg	6.825	± 4.170
Etelcalcetide 60 mg	12.464	± 12.914

4 Hours

Group	Value	95% CI
Pooled Placebo	34.681	± 17.635
Etelcalcetide 5 mg	29.766	± 10.970
Etelcalcetide 10 mg	6.392	± 6.138
Etelcalcetide 20 mg	21.940	± 13.151
Etelcalcetide 40 mg	26.340	± 10.814
Etelcalcetide 60 mg	17.068	± 5.053

8 Hours

Group	Value	95% CI
Pooled Placebo	53.138	± 26.860
Etelcalcetide 5 mg	31.981	± 22.948
Etelcalcetide 10 mg	-2.240	± 9.168
Etelcalcetide 20 mg	17.850	± 11.838
Etelcalcetide 40 mg	23.291	± 26.675
Etelcalcetide 60 mg	26.854	± 17.662

18 Hours

Group	Value	95% CI
Pooled Placebo	75.585	± 43.897
Etelcalcetide 5 mg	57.263	± 23.373
Etelcalcetide 10 mg	0.424	± 6.565
Etelcalcetide 20 mg	17.405	± 17.156
Etelcalcetide 40 mg	24.889	± 24.901
Etelcalcetide 60 mg	19.266	± 24.212

24 Hours

Group	Value	95% CI
Pooled Placebo	77.196	± 51.499
Etelcalcetide 5 mg	50.020	± 23.032
Etelcalcetide 10 mg	-9.383	± 7.930
Etelcalcetide 20 mg	17.795	± 29.202
Etelcalcetide 40 mg	14.095	± 38.924
Etelcalcetide 60 mg	18.115	± 30.774

32 Hours

Group	Value	95% CI
Pooled Placebo	87.730	± 51.888
Etelcalcetide 5 mg	62.691	± 32.631
Etelcalcetide 10 mg	2.355	± 8.476
Etelcalcetide 20 mg	16.331	± 21.671
Etelcalcetide 40 mg	25.814	± 39.166
Etelcalcetide 60 mg	33.902	± 27.795

42 Hours

Group	Value	95% CI
Pooled Placebo	88.570	± 48.114
Etelcalcetide 5 mg	62.568	± 28.246
Etelcalcetide 10 mg	5.055	± 11.224
Etelcalcetide 20 mg	19.449	± 29.865
Etelcalcetide 40 mg	30.694	± 30.875
Etelcalcetide 60 mg	25.046	± 36.401

Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide Secondary · 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).

Group	Value	95% CI
Etelcalcetide 5 mg	145	± 64.8
Etelcalcetide 10 mg	263	± 67.2
Etelcalcetide 20 mg	511	± 230
Etelcalcetide 40 mg	726	± 278
Etelcalcetide 60 mg	1140	± 428

Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide Secondary · 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).

Group	Value	95% CI
Etelcalcetide 5 mg	1110	± 182
Etelcalcetide 10 mg	2820	± 458
Etelcalcetide 20 mg	4920	± 1650
Etelcalcetide 40 mg	9560	± 3340
Etelcalcetide 60 mg	15700	± 5100

Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide Secondary · 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).

Group	Value	95% CI
Etelcalcetide 5 mg	3180	± 1350
Etelcalcetide 10 mg	5280	± 970
Etelcalcetide 20 mg	16800	± 4560
Etelcalcetide 60 mg	43800	± 16900

Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide Secondary · 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).

Group	Value	95% CI
Etelcalcetide 5 mg	64.6	± 11.4
Etelcalcetide 10 mg	50.9	± 9.55
Etelcalcetide 20 mg	71.7	± 5.96
Etelcalcetide 40 mg	60.2	± 25.8
Etelcalcetide 60 mg	68.0	± 8.24

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pooled Placebo

Serious: 1/20 (5%)

Deaths: —

Etelcalcetide 5 mg

Serious: 0/4 (0%)

Deaths: —

Etelcalcetide 10 mg

Serious: 0/3 (0%)

Deaths: —

Etelcalcetide 20 mg

Serious: 0/4 (0%)

Deaths: —

Etelcalcetide 40 mg

Serious: 0/4 (0%)

Deaths: —

Etelcalcetide 60 mg

Serious: 0/4 (0%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Pooled Placebo	Etelcalcetide 5 mg	Etelcalcetide 10 mg	Etelcalcetide 20 mg	Etelcalcetide 40 mg	Etelcalcetide 60 mg
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	—	—	—	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Pooled Placebo	Etelcalcetide 5 mg	Etelcalcetide 10 mg	Etelcalcetide 20 mg	Etelcalcetide 40 mg	Etelcalcetide 60 mg
CALCIUM IONISED DECREASED	Investigations	—	—	—	—	—	—
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	—	—	—	—	—	—
TOOTHACHE	Gastrointestinal disorders	—	—	—	—	—	—
INJECTION SITE PRURITUS	General disorders	—	—	—	—	—	—
PARAESTHESIA	Nervous system disorders	—	—	—	—	—	—

Most-reported serious reactions: CARDIAC FAILURE CONGESTIVE.

Data from ClinicalTrials.gov NCT01134562 adverse events section.

Sponsor's own description

The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Etelcalcetide

Trials testing the same drug.

NCT03969329 — A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis · Phase 3 · recruiting
NCT03795558 — A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Ser · Phase 2 · completed
NCT03633708 — A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemo · Phase 3 · recruiting
NCT03960437 — The Effect of Etelcalcetide on CKD-MBD · Phase 2 · completed
NCT03299244 — Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SH · Phase 3 · completed

Other KAI Pharmaceuticals trials

Trials by the same sponsor.

NCT01414114 — Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bo · Phase 2 · completed
NCT01134549 — Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01134562 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by KAI Pharmaceuticals
Last refreshed: 2 January 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01134562.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01134562

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Etelcalcetide

Other KAI Pharmaceuticals trials

Verify against primary sources