Chronic Kidney DiseasePhase 2NCT01439867
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
A Phase 2 study testing Cinacalcet hydrochloride in people with Chronic Kidney Disease and Hyperparathyroidism, Secondary, run by Amgen at 42 sites in 13 countries.
Trial summary
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT). Read more about this study
- Who is it for?
- Ages 28 to 2189 days
- Conditions the study is for
- Chronic Kidney Disease, Hyperparathyroidism, Secondary
- What is being tested?
- Cinacalcet hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 42 sitesin 13 countries
- Study dates
- 22 Jun 2012to 3 Jun 2016
- 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 28 to 2189 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects between the ages of 28 days to < 6 years of age at enrollment (Czech Republic minimum age is ≥ 2 years of age at enrollment)
- Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing
- Screening corrected calcium from the central laboratory:
- ≥ 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years
- ≥ 8.8 (2.2 mmol/L) if age ≥ 2 to < 6 years
- Serum phosphorus from the central laboratory:
Show all 10Show fewer
- ≥ 5.0 mg/dL (1.25 mmol/L) if age 28 days to < 1 year
- ≥ 4.5 mg/dL (1.13 mmol/L) if age ≥ 1 to < 6 years
- SHPT not due to vitamin D deficiency, per investigator assessment
- Dry weight ≥ 7 kg at the time of screening
Who cannot join
- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
- Corrected QT interval (QTc) > 500 ms, using Bazett's formula
- QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
- Use of grapefruit juice, herbal medications, or potent CYP 3A4 inhibitors (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole)
- Use of concomitant medications that may prolong the QTc interval (e.g., ondansetron, albuterol)
Trial locations and contacts
42 sites in 13 countries.
42 sites in 13 countries
United States17 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Baltimore, Maryland, 21287
Research Site
Birmingham, Alabama, 35233
Research Site
Cincinnati, Ohio, 45229
Research Site
Dallas, Texas, 75390
Research Site
Greenville, North Carolina, 27834
Research Site
Houston, Texas, 77030
Research Site
Iowa City, Iowa, 52242
Research Site
Kansas City, Missouri, 64108
Research Site
Little Rock, Arkansas, 72202
Research Site
Los Angeles, California, 90095
Research Site
Louisville, Kentucky, 40202
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
San Antonio, Texas, 78229
Research Site
St Louis, Missouri, 63110
Research Site
The Bronx, New York, 10467
France5 sites
Research Site
Bron, 69677
Research Site
Lille, 59800
Research Site
Paris, 75012
Research Site
Paris, 75015
Research Site
Paris, 75019
Belgium3 sites
Research Site
Brussels, 1020
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Hungary3 sites
Research Site
Budapest, 1083
Research Site
Debrecen, 4032
Research Site
Szeged, 6720
Italy3 sites
Research Site
Genova, 16147
Research Site
Roma, 00165
Research Site
Torino, 10126
Poland3 sites
Research Site
Gdansk, 80-952
Research Site
Krakow, 30-663
Research Site
Warsaw, 00-576
Russia2 sites
Research Site
Moscow, 107014
Research Site
Saint Petersburg, 198205
About this study
Official title: An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
Read the detailed description
This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first.
The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes.
Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).
- Being tested
- Cinacalcet hydrochloride, Standard of Care
- Keywords
- Dialysis, Sensipar, Mimpara, Hemodialysis, Peritoneal Dialysis, Renal, Parathyroid hormone, Pediatric
- 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.
Cinacalcet hydrochlorideDrug
Also called Sensipar®, Mimpara®
Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily.
Standard of CareDrug
Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Cinacalcet | Experimental | Prior to the partial clinical hold, the starting dose was 0.25 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 4.2 mg/kg) based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms.
After the partial clinical hold the starting dose was 0.20 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 2.5 or 60 mg, whichever was lower) based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms.
All participants also received standard of care, which may have included vitamin D sterols. Receives: Drug: Cinacalcet hydrochloride; Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Hypocalcemia
Hypocalcemia was defined as corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to < 6 years at any time during the study.
Measured: 26 weeks
Secondary outcomes (11)
Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study
Measured: 26 weeks
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Measured: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percent Change From Baseline in Corrected Serum Calcium
Measured: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percent Change From Baseline in Serum Phosphorous
Measured: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)
Measured: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements
A participant was considered to have achieved > 30% reduction in iPTH from baseline at any 2 consecutive measurements if percent change of any two consecutive post-baseline iPTH values were < -30% regardless if there was a missing value in between.
Measured: 26 weeks
Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study
A participant was considered to have achieved ≥ 30% reduction in iPTH if the percent change of any post-baseline iPTH value was ≤ -30% from baseline.
Measured: 26 weeks
Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements
A participant was considered to have achieved iPTH between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements if any two consecutive post-baseline iPTH values were within the range regardless if there was a missing value in between. The analysis included all enrolled subjects with at least 1 post-baseline assessment.
Measured: 26 weeks
Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study
A participant was considered to have achieved iPTH < 300 pg/mL (31.8 pmol/L) during the study if any post-baseline iPTH value was < 300 pg/mL.
Measured: 26 weeks
Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet
Measured: Week 12
Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study start22 Jun 2012
- Primary completion3 Jun 2016
- Study completion3 Jun 2016
Why it stopped: Amgen decided to terminate the study early to be able to meet US regulatory timelines fo filing. Subjects in treatment were rolled over to the 20140159 study.
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 (2)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT01439867
- Sponsor's protocol ID
- 20110100
- Other IDs
- 2011-004618-40
- Status last verified
- Jun 2020
- First submitted
- 22 Sep 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 30756425Warady 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
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-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis
- ClinicalTrials.gov ID
- NCT01439867
- Acronym / sponsor ID
- 20110100
- Keywords
- Dialysis, Sensipar, Mimpara, Hemodialysis, Peritoneal Dialysis, Renal, Parathyroid hormone, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Amgen decided to terminate the study early to be able to meet US regulatory timelines fo filing. Subjects in treatment were rolled over to the 20140159 study.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2012 (actual)
- Primary completion
- 3 Jun 2016 (actual)
- Study completion
- 3 Jun 2016 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Posted 11 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
Detailed description
This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first.
The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes.
Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).
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: Cinacalcet hydrochloride, Drug: Standard of CarePrior to the partial clinical hold, the starting dose was 0.25 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 4.2 mg/kg) based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms. After the partial clinical hold the starting dose was 0.20 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 2.5 or 60 mg, whichever was lower) based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms. All participants also received standard of care, which may have included vitamin D sterols. |
Who may qualify
- Ages
- 28 to 2189 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Subjects between the ages of 28 days to < 6 years of age at enrollment (Czech Republic minimum age is ≥ 2 years of age at enrollment)
- Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing
- Screening corrected calcium from the central laboratory:
- ≥ 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years
- ≥ 8.8 (2.2 mmol/L) if age ≥ 2 to < 6 years
Key exclusion criteria (5 listed)
- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
- Corrected QT interval (QTc) > 500 ms, using Bazett's formula
- QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
- Use of grapefruit juice, herbal medications, or potent CYP 3A4 inhibitors (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole)
- Use of concomitant medications that may prolong the QTc interval (e.g., ondansetron, albuterol)
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 |
|---|---|---|
| Cinacalcet hydrochlorideAlso: Sensipar®, Mimpara®Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily. | Drug | Cinacalcet |
| Standard of CareStandard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator. | Drug | Cinacalcet |
Primary outcome
Percentage of Participants With Hypocalcemia
Time frame: 26 weeks
Hypocalcemia was defined as corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to < 6 years at any time during the study.
11 secondary outcomes
Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study
Time frame: 26 weeks
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Time frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percent Change From Baseline in Corrected Serum Calcium
Time frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percent Change From Baseline in Serum Phosphorous
Time frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)
Time frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements
Time frame: 26 weeks
Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study
Time frame: 26 weeks
Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements
Time frame: 26 weeks
Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study
Time frame: 26 weeks
Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet
Time frame: Week 12
Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
Time frame: Week 12
Results and safety
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 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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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
42 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cinacalcet hydrochloride in people with Chronic Kidney Disease and Hyperparathyroidism, Secondary, run by Amgen at 42 sites in 13 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 5 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: stopped early, 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 42 sites in United States, France, Belgium, Hungary, Italy and 8 more countries. 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 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 Aug 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 Hypocalcemia (time frame: 26 weeks). 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 NCT01439867, which also lists 2 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.