Secondary HyperparathyroidismPhase 2NCT01414114

Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder

A Phase 2 study testing Etelcalcetide in people with Secondary Hyperparathyroidism, run by KAI Pharmaceuticals.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Secondary Hyperparathyroidism
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: 37 participants
Where: No sites listed yet
Study dates: 5 Dec 2011to 21 May 2012
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects provides written informed consent
Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL
Hemoglobin ≥ 8.5 g/dL
Serum transaminases (alanine transaminase [ALT], aspartate transaminase [AST]) less than 2.5 times the upper limit of normal
Adequate hemodialysis three times per week

Who cannot join

History or symptomatic ventricular dysrhythmias
History of angina pectoris or congestive heart failure
History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
History of or treatment for seizure disorder within the last 12 months
Postdialysis systolic blood pressure > 180 mmHg or diastolic blood pressure > 90 mmHg
Serum magnesium below the lower limit of normal at screening

About this study

Official title: A Single-arm, Open-label, Multicenter, Dose Titration Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects With Chronic Kidney Disease-Mineral and Bone Disorder

Conditions: Secondary Hyperparathyroidism
Being tested: Etelcalcetide
Keywords: Clinical Trial, Phase 2, Renal Dialysis, Secondary Hyperparathyroidism, Chronic kidney disease-mineral and bone disorder, Parathyroid hormone
Medical subject headings: Hyperparathyroidism, Secondary, Chronic Kidney Disease-Mineral and Bone Disorder

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™
Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.

Study groups in NCT01414114
Study group	Role	What they receive
Etelcalcetide	Experimental	Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range. Receives: Drug: Etelcalcetide

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Measured: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)

Secondary outcomes (4)

Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period
The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Measured: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period
The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Measured: The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Percent Change From Baseline in Corrected Calcium During the Efficacy Period
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Measured: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Percent Change From Baseline in Phosphorus During the Efficacy Period
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Measured: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201121 May 2012

First posted11 Aug 2011 (estimated)
Study start5 Dec 2011
Primary completion21 May 2012
Study completion21 May 2012

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 Secondary HyperparathyroidismStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01414114
Sponsor's protocol ID: KAI-4169-005
Other IDs: 20120331
Status last verified: Feb 2017
First submitted: 9 Aug 2011
Last updated: 11 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder

All Secondary Hyperparathyroidism trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, Open-label, Multicenter, Dose Titration Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects With Chronic Kidney Disease-Mineral and Bone Disorder
ClinicalTrials.gov ID: NCT01414114
Acronym / sponsor ID: KAI-4169-005
Conditions: Secondary Hyperparathyroidism
Keywords: Clinical Trial, Phase 2, Renal Dialysis, Secondary Hyperparathyroidism, Chronic kidney disease-mineral and bone disorder, Parathyroid hormone
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: KAI PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 5 Dec 2011
Primary completion: 21 May 2012 (actual)
Study completion: 21 May 2012 (actual)
First posted: 11 Aug 2011 (estimated)
Results: Posted 11 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects provides written informed consent
Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL
Hemoglobin ≥ 8.5 g/dL
Serum transaminases (alanine transaminase [ALT], aspartate transaminase [AST]) less than 2.5 times the upper limit of normal
Adequate hemodialysis three times per week

Key exclusion criteria (6 listed)

History or symptomatic ventricular dysrhythmias
History of angina pectoris or congestive heart failure
History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
History of or treatment for seizure disorder within the last 12 months
Postdialysis systolic blood pressure > 180 mmHg or diastolic blood pressure > 90 mmHg

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™Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.	Drug	Etelcalcetide

Primary outcome

Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period
Time frame: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.

4 secondary outcomes

Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period
Time frame: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period
Time frame: The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Percent Change From Baseline in Corrected Calcium During the Efficacy Period
Time frame: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Percent Change From Baseline in Phosphorus During the Efficacy Period
Time frame: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)

Results and safety

Results posted to the registry on 11 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etelcalcetide	37	32

Primary outcome: Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period

Time frame: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment). Mean (Standard Deviation). Unit: percent change

Measure	Etelcalcetide n = 36	Baseline PTH ≤ 700 pg/mL n = 21	Baseline PTH > 700 pg/mL n = 15
Value	-53.6 (21.42)	-55.6 (19.65)	-50.8 (24.12)

Population analysed: The modified intent-to-treat population (all participants who were randomized and received treatment) with available data at both time points.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study drug up to 4 weeks after the last dose; 16 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etelcalcetide	3 of 37 (8.1%)	18 of 37 (48.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Secondary Hyperparathyroidism

RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder

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.

Gregory Bell, MD study director

KAI Pharmaceuticals

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etelcalcetide in people with Secondary Hyperparathyroidism, run by KAI Pharmaceuticals.

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 5 inclusion and 6 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 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?

Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period (time frame: Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01414114.

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 11 Apr 2017.