Chronic Kidney DiseasePhase 1NCT01290029

Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease

A Phase 1 study testing Cinacalcet in people with Chronic Kidney Disease and Hyperparathyroidism, Secondary, run by Amgen at 10 sites in 3 countries.

Completed

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

Official record

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Trial summary

The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis. Read more about this study

Who is it for?: Ages 28 to 2190 days
Conditions the study is for: Chronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary Hyperparathyroidism
What is being tested?: Cinacalcet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 10 sitesin 3 countries
Study dates: 25 Jan 2011to 23 Sep 2015
Phase: Phase 1
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 28 to 2190 days
All sexes
No healthy volunteers
Child

Who may be able to join

Subject's parent, or legally acceptable guardian, must sign an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved Informed Consent Form.
Subjects 28 days to < 6 years of age with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT) as diagnosed by principal investigators, undergoing hemodialysis or peritoneal dialysis at the time of screening (subjects 6 months or older should have been receiving dialysis for ≥ 1 months) and who have not received any cinacalcet HCl therapy for at least 2 weeks prior to dosing on Day 1
Free of any disease or condition (other than those diseases or conditions related to their renal disease that, in the opinion of the investigator, would impact the subject's safety or the integrity of the study data).
Must weigh ≥ 6 kg at screening and at Day-1.
Must be at least 30 weeks of gestational age.
Physical examination must be acceptable to the investigator at screening and at Day -1.

Show all 10Show fewer

Hemoglobin ≥ 8 g/dL at screening and at Day -1.
Serum calcium within age-appropriate normal ranges per the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI) guidelines at screening and at Day -1
Normal or clinically acceptable electrocardiogram (ECG) (12-lead reporting RR, PR, QRS, and QTc intervals) at screening and at Day -1.
Clinical laboratory tests that are acceptable to the investigator at screening and at Day -1.

Who cannot join

Current or historic malignancy.
Cardiac ventricular arrhythmias within 28 days prior to screening.
A gastrointestinal disorder or surgery that could affect the absorption of drugs (eg, pyloric stenosis or any gut-shortening surgical procedure prior to screening).
A new onset of seizure or worsening of a pre-existing seizure disorder within 2 months prior to IP administration.
Major surgery (defined as any surgical procedure that involves general anesthesia or respiratory assistance) within 28 days prior to screening.
Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase (AST) ≥ 1.5 x upper limit of normal (ULN) OR alanine aminotransferase (ALT) ≥ 1.5 x ULN OR total bilirubin ≥ 1 x ULN per institutional laboratory range) at screening or Day-1.

Show all 15Show fewer

History of prolongation of the QT interval (eg, congenital long QT interval, second or third degree heart block or other conditions which prolong the QT interval)
Corrected QT Interval (QTc) > 500 ms during screening, using Bazett's formula
QTc ≥ 450 and ≤ 500 ms during screening, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
Known hypersensitivity to cinacalcet HCl or any of the excipients in cinacalcet HCl.
Use of grapefruit juice, herbal medications or potent CYP 3A4 inhibitors (eg, erythromycin, clarithromycin, ketokonazole, itraconazole) within the 14 days prior to enrollment and during the study.
Concurrent or within 28 days prior to enrollment use of medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (eg, flecainide, vinblastine, thioridazine, tricyclic antidepressants such as desipramine and imipramine, and beta-blockers such as metoprolol or carvedilol).
Concurrent or within 28 days prior to enrollment use of medications that prolong QT interval (eg, sotalol, amiodarone, erythromycin, or clarithromycin).
Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(s).
Other investigational procedures while participating in this study are excluded.

Trial locations and contacts

10 sites in 3 countries.

Country

City, postcode or hospital

10 sites in 3 countries

United Kingdom5 sites

Research Site
Bristol, BS2 8BJ
Research Site
Glasgow, G3 8SJ
Research Site
Leeds, LS1 3EX
Research Site
Manchester, M13 9WL
Research Site
Nottingham, NG7 2UH

Other trials in United Kingdom

United States4 sites

Research Site
Kansas City, Missouri, 64108
Research Site
Los Angeles, California, 90095
Research Site
Louisville, Kentucky, 40202
Research Site
San Francisco, California, 94143

Other trials in United States

Germany1 site

Research Site
Heidelberg, 69120

Other trials in Germany

About this study

Official title: An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cinacalcet HCl in Pediatric Subjects Aged 28 Days to Less Than 6 Years With Chronic Kidney Disease Receiving Dialysis

Conditions: Chronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary Hyperparathyroidism
Being tested: Cinacalcet
Keywords: pediatric, CKD, dialysis, paediatric
Medical subject headings: Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CinacalcetDrug
Also called Sensipar®, Mimpara®
Single, oral dose of 0.25 mg/kg cinacalcet

Study groups in NCT01290029
Study group	Role	What they receive
Cinacalcet	Experimental	Participants received a single, oral dose of 0.25 mg/kg cinacalcet. Receives: Drug: Cinacalcet

What is being measured

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

Number of Participants With Adverse Events
A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.
Measured: Day 1 to day 30

Secondary outcomes (9)

Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
Measured: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet
Measured: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Cinacalcet
Measured: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax)
Measured: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Terminal Half-life of Cinacalcet
The terminal half-life (T1/2) of cinacalcet associated with the slope of the terminal phase.
Measured: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Percent Change From Baseline in Intact Parathyroid Hormone
Measured: Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Total Calcium
Measured: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Albumin Corrected Calcium
Measured: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Ionized Calcium
Measured: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.

Timeline

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

25 Jan 201123 Sep 2015

First posted4 Feb 2011 (estimated)
Study start25 Jan 2011
Primary completion23 Sep 2015
Study completion23 Sep 2015

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01290029
Sponsor's protocol ID: 20090005
Status last verified: Jun 2020
First submitted: 20 Jan 2011
Last updated: 17 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.
PubMed 30756425
Sohn WY, Portale AA, Salusky IB, Zhang H, Yan LL, Ertik B, Shahinfar S, Lee E, Dehmel B, Warady BA. An open-label, single-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cinacalcet in pediatric subjects aged 28 days to < 6 years with chronic kidney disease receiving dialysis. Pediatr Nephrol. 2019 Jan;34(1):145-154. doi: 10.1007/s00467-018-4054-8. Epub 2018 Aug 23.
PubMed 30141180
Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.
PubMed 32367309

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?

See locations

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All Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cinacalcet HCl in Pediatric Subjects Aged 28 Days to Less Than 6 Years With Chronic Kidney Disease Receiving Dialysis
ClinicalTrials.gov ID: NCT01290029
Acronym / sponsor ID: 20090005
Conditions: Chronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary Hyperparathyroidism
Keywords: pediatric, CKD, dialysis, paediatric
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 25 Jan 2011 (actual)
Primary completion: 23 Sep 2015 (actual)
Study completion: 23 Sep 2015 (actual)
First posted: 4 Feb 2011 (estimated)
Results: Posted 19 Dec 2016

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
Cinacalcet	Experimental	Drug: CinacalcetParticipants received a single, oral dose of 0.25 mg/kg cinacalcet.

Who may qualify

Ages: 28 to 2190 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

Subject's parent, or legally acceptable guardian, must sign an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved Informed Consent Form.
Subjects 28 days to < 6 years of age with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT) as diagnosed by principal investigators, undergoing hemodialysis or peritoneal dialysis at the time of screening (subjects 6 months or older should have been receiving dialysis for ≥ 1 months) and who have not received any cinacalcet HCl therapy for at least 2 weeks prior to dosing on Day 1
Free of any disease or condition (other than those diseases or conditions related to their renal disease that, in the opinion of the investigator, would impact the subject's safety or the integrity of the study data).
Must weigh ≥ 6 kg at screening and at Day-1.
Must be at least 30 weeks of gestational age.

Key exclusion criteria (15 listed)

Current or historic malignancy.
Cardiac ventricular arrhythmias within 28 days prior to screening.
A gastrointestinal disorder or surgery that could affect the absorption of drugs (eg, pyloric stenosis or any gut-shortening surgical procedure prior to screening).
A new onset of seizure or worsening of a pre-existing seizure disorder within 2 months prior to IP administration.
Major surgery (defined as any surgical procedure that involves general anesthesia or respiratory assistance) within 28 days prior to screening.

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
CinacalcetAlso: Sensipar®, Mimpara®Single, oral dose of 0.25 mg/kg cinacalcet	Drug	Cinacalcet

Primary outcome

Number of Participants With Adverse Events
Time frame: Day 1 to day 30
A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.

9 secondary outcomes

Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
Time frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet
Time frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Cinacalcet
Time frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax)
Time frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Terminal Half-life of Cinacalcet
Time frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Percent Change From Baseline in Intact Parathyroid Hormone
Time frame: Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Total Calcium
Time frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Albumin Corrected Calcium
Time frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Ionized Calcium
Time frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.

Results and safety

Results posted to the registry on 19 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cinacalcet 0.25 mg/kg	14	12

Primary outcome: Number of Participants With Adverse Events

Time frame: Day 1 to day 30. Number. Unit: participants

Measure	Cinacalcet 0.25 mg/kg n = 12
Any adverse event (AE)	3
Serious adverse events	0
AE leading to discontinuation of study drug	0
Fatal adverse events	0
Treatment-related adverse events	1
Adverse events of interest	1

Population analysed: All participants who received at least 1 dose of cinacalcet.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cinacalcet 0.25 mg/kg	0 of 12 (0%)	3 of 12 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30756425Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.
Background: PubMed 30141180Sohn WY, Portale AA, Salusky IB, Zhang H, Yan LL, Ertik B, Shahinfar S, Lee E, Dehmel B, Warady BA. An open-label, single-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cinacalcet in pediatric subjects aged 28 days to < 6 years with chronic kidney disease receiving dialysis. Pediatr Nephrol. 2019 Jan;34(1):145-154. doi: 10.1007/s00467-018-4054-8. Epub 2018 Aug 23.
Background: PubMed 32367309Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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Recruiting
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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

10 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cinacalcet in people with Chronic Kidney Disease and Hyperparathyroidism, Secondary, run by Amgen at 10 sites in 3 countries.

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 10 inclusion and 15 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom, United States, Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 19 Dec 2016). 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?

Number of Participants With Adverse Events (time frame: Day 1 to day 30). 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 NCT01290029, which also lists 3 linked publications.

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 Jun 2020.