Hyperparathyroidism, SecondaryPhase 3NCT01932970
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
A Phase 3 study testing Etelcalcetide in people with Hyperparathyroidism, Secondary, run by Amgen at 40 sites in United States.
Trial summary
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hyperparathyroidism, Secondary
- What is being tested?
- Etelcalcetide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 40 sitesUnited States
- Study dates
- 12 Aug 2013to 14 Feb 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age or older at the time of informed consent.
- Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.
- Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
- Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
- Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).
- Other Inclusion Criteria may apply.
Who cannot join
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
- Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).
- Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.
- Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.
- Subject is pregnant or nursing.
- Anticipated or scheduled parathyroidectomy during the study period.
- Subject has received a parathyroidectomy within 6 months prior to dosing.
- Other Exclusion Criteria may apply.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Research Site
Alhambra, California, 91801
Research Site
Arlington, Texas, 76015
Research Site
Arvada, Colorado, 80002
Research Site
Augusta, Georgia, 30909
Research Site
Azusa, California, 91702
Research Site
Bakersfield, California, 93308
Research Site
Baton Rouge, Louisiana, 70808
Research Site
Chula Vista, California, 91910
Research Site
College Point, New York, 11356
Research Site
Columbus, Mississippi, 39705
Research Site
Coral Springs, Florida, 33071
Research Site
Eatontown, New Jersey, 07724
Research Site
Evergreen Park, Illinois, 60805
Research Site
Fairfax, Virginia, 22033
Research Site
Farmington, Missouri, 63640
Research Site
Greenville, Texas, 75402
Research Site
Gulfport, Mississippi, 39501
Research Site
Hampton, Virginia, 23666
Research Site
Hollywood, Florida, 33021
Research Site
Houston, Texas, 77004
Research Site
Kansas City, Missouri, 64111
Research Site
La Mesa, California, 91942
Research Site
Lafayette, Louisiana, 70506
Research Site
Los Angeles, California, 90022
Research Site
Lynwood, California, 90262
Research Site
McAllen, Texas, 78503
Research Site
Miami, Florida, 33150
Research Site
Michigan City, Indiana, 46360
Research Site
North Haven, Connecticut, 06473
Research Site
Oklahoma City, Oklahoma, 73116
Research Site
Orangeburg, South Carolina, 29118
Research Site
Pembroke Pines, Florida, 33028
Research Site
Philadelphia, Pennsylvania, 19106
Research Site
Pinecrest, Florida, 33156
Research Site
Portsmouth, New Hampshire, 03801
Research Site
Riverside, California, 92505
Research Site
San Antonio, Texas, 78229
Research Site
St Louis, Missouri, 63136
Research Site
Tampa, Florida, 33614
Research Site
Whittier, California, 90603
About this study
Official title: A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).
- Conditions
- Hyperparathyroidism, Secondary
- Being tested
- Etelcalcetide
- Keywords
- Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtelcalcetideDrug
Also called KAI 4169, AMG 416, Parsabiv™
Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
| Study group | Role | What they receive |
|---|---|---|
| Etelcalcetide | Experimental | Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks. Receives: Drug: Etelcalcetide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period
Measured: 4 weeks
Secondary outcomes (2)
Percent Change From Baseline in Parathyroid Hormone During the Treatment Period
Measured: Baseline and weeks 2, 3 and 4
Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study start12 Aug 2013
- Primary completion14 Jan 2014
- Study completion14 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hyperparathyroidism, SecondaryStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932970
- Sponsor's protocol ID
- 20120359
- Other IDs
- 2013-000964-28, KAI-4169
- Status last verified
- Sep 2018
- First submitted
- 28 Aug 2013
- Last updated
- 17 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416
- ClinicalTrials.gov ID
- NCT01932970
- Acronym / sponsor ID
- 20120359
- Conditions
- Hyperparathyroidism, Secondary
- Keywords
- Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2013 (actual)
- Primary completion
- 14 Jan 2014 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etelcalcetide | Experimental | Drug: EtelcalcetideParticipants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is 18 years of age or older at the time of informed consent.
- Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.
- Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
- Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
- Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).
Key exclusion criteria (8 listed)
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
- Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).
- Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.
- Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.
- Subject is pregnant or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtelcalcetideAlso: KAI 4169, AMG 416, Parsabiv™Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection. | Drug | Etelcalcetide |
Primary outcome
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period
Time frame: 4 weeks
2 secondary outcomes
Percent Change From Baseline in Parathyroid Hormone During the Treatment Period
Time frame: Baseline and weeks 2, 3 and 4
Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etelcalcetide in people with Hyperparathyroidism, Secondary, run by Amgen at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.