Secondary Hyperparathyroidism Clinical Trial
Official title:
A Phase 1, Multiple Dose, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pharmacokinetics, Safety and Tolerability of AMG 416 Administered Intravenously to Chinese Subjects With Chronic Kidney Disease on Hemodialysis
This was a multiple-dose, double-blind, randomized, placebo-controlled study. Chinese
subjects residing in Mainland China with chronic kidney disease (CKD) receiving hemodialysis
were randomized in a 3:1 ratio to receive 5 mg intravenous (IV) of etelcalcetide or placebo 3
times a week (TIW) for approximately 4 weeks, with a subsequent follow up period of
approximately 4 weeks.
Doses were given at the end of each scheduled hemodialysis session on study days 1 through
day 27 and subject participation was complete after day 55 end-of-study (EOS) procedures were
performed. Doses were administered TIW for 4 weeks, for a total of 12 doses.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02549417 -
Phase 3 Study of KHK7580
|
Phase 3 | |
| Completed |
NCT02549404 -
Phase 3 Study of KHK7580
|
Phase 3 | |
| Completed |
NCT02549391 -
Phase 3 Study of KHK7580
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT02536287 -
Comparison of Total Parathyroidectomy With and Without Autotransplantation
|
Phase 3 | |
| Active, not recruiting |
NCT03023748 -
Intravenous Paricalcitol in Chronic Hemodialysis Patients
|
Phase 4 | |
| Withdrawn |
NCT01426724 -
Effects of Vitamin D on Renal Blood Flow, Proteinuria and Inflammation in Patients With Chronic Kidney Disease
|
N/A | |
| Completed |
NCT01101113 -
Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level
|
Phase 4 | |
| Completed |
NCT01220050 -
Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism
|
Phase 2 | |
| Completed |
NCT00537979 -
Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
|
Phase 4 | |
| Completed |
NCT00431496 -
A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)
|
Phase 4 | |
| Completed |
NCT00379899 -
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
|
Phase 4 | |
| Completed |
NCT00117052 -
SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
|
Phase 3 | |
| Completed |
NCT00073710 -
Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
|
Phase 4 | |
| Completed |
NCT03626948 -
SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
|
Phase 3 | |
| Completed |
NCT01382212 -
A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
|
Phase 3 | |
| Completed |
NCT01219855 -
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
|
Phase 2/Phase 3 | |
| Completed |
NCT01224782 -
Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
|
N/A | |
| Completed |
NCT00990704 -
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
|
Phase 2 | |
| Completed |
NCT00999037 -
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
|
N/A | |
| Completed |
NCT00742716 -
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
|
Phase 2 |