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NCT03633708 · ClinicalTrials.gov registry record · Phase 3
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
A Phase 3 study of Chronic Kidney Disease and Secondary Hyperparathyroidism, sponsored by Amgen.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
- 20
- Study locations
NCT03633708: Recruiting Phase 3 study of Chronic Kidney Disease and Secondary Hyperparathyroidism, sponsored by Amgen.
NCT03633708 is a Phase 3 study of Chronic Kidney Disease and Secondary Hyperparathyroidism that is actively recruiting participants, run by Amgen. The registered enrollment target is 56 participants, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03633708, a Phase 3 study of Chronic Kidney Disease and Secondary Hyperparathyroidism, is actively recruiting participants, sponsored by Amgen.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
Primary Outcome
Achievement of at least a 30% reduction from baseline in mean iPTH during the EAP (defined as weeks 20 through 27).
Conditions Studied
Interventions
- OTHER Standard of Care
- DRUG Etelcalcetide
Study Locations (20)
National Capital Territory of Delhi
- Fortis Flt Lt Rajan Dhall Hospital - New Delhi
- All India Institute of Medical Sciences - New Delhi
- Sir Ganga Ram Hospital - New Delhi
Ohio
- Cincinnati Childrens Hospital Medical Center - Cincinnati
- Cleveland Clinic Foundation - Cleveland
Buenos Aires
- Fresenius Escobar - Belén de Escobar
- Hospital Italiano - Cuidad Autonoma de Buenos Aires
Karnataka
- Manipal Hospital - Bangalore
- KLES Dr Prabhakar Kore Hospital and Medical Research Centre - Belagavi
California
- Childrens Hospital of Los Angeles - Los Angeles
Colorado
- Childrens Hospital Colorado - Aurora
Missouri
- Childrens Mercy Hospital - Kansas City
New York
- Mount Sinai Kidney Center - B1 Renal Treatment - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2019-04-29 |
| Est. Completion | 2029-01-31 |
| Phase | Phase 3 |
What NCT03633708 shows while recruiting
NCT03633708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT03633708 names 20 study sites across 15 states, led by National Capital Territory of Delhi, Ohio, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT03633708 about?
NCT03633708 is a clinical study titled "A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis". This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
What is the current status of trial NCT03633708?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2019-04-29. Estimated completion is 2029-01-31.
What conditions does trial NCT03633708 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism.
What interventions are being tested in trial NCT03633708?
The interventions under investigation include: Standard of Care (OTHER), Etelcalcetide (DRUG).
Who is sponsoring clinical trial NCT03633708?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03633708 being conducted?
This trial has 20 study locations across California, Colorado, Missouri, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03633708's enrollment target sits among peer trials
56 73rd of 101 higher than 29 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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