Chronic Kidney Disease, Secondary HyperparathyroidismPhase 3NCT02138838
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
A Phase 3 study testing Cinacalcet HCl in people with Chronic Kidney Disease, Secondary Hyperparathyroidism, run by Amgen at 60 sites in 16 countries.
Trial summary
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Chronic Kidney Disease, Secondary Hyperparathyroidism
- What is being tested?
- Cinacalcet HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 60 sitesin 16 countries
- Study dates
- 7 Nov 2014to 23 Jun 2016
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 - < 18 years
- Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values ≥ 300 pg/mL during screening
- Corrected calcium value of ≥ 8.8 mg/dL during screening
- Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days prior to screening
- Parent or legally acceptable representative has provided written informed consent and subject has provided written assent when required by institutional guidelines
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 cytochrome P450 3A4 (CYP3A4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
- Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
Trial locations and contacts
60 sites in 16 countries.
60 sites in 16 countries
United States26 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Baltimore, Maryland, 21287
Research Site
Boston, Massachusetts, 02115
Research Site
Chicago, Illinois, 60612
Research Site
Cincinnati, Ohio, 45229
Research Site
Cleveland, Ohio, 44106
Research Site
Columbus, Ohio, 43205
Research Site
Dallas, Texas, 75235
Research Site
Detroit, Michigan, 48201
Research Site
Greenville, North Carolina, 27834
Research Site
Houston, Texas, 77030
Research Site
Iowa City, Iowa, 52242
Research Site
Jackson, Mississippi, 39216
Research Site
Kansas City, Missouri, 64108
Research Site
Los Angeles, California, 90027
Research Site
Louisville, Kentucky, 40202
Research Site
Minneapolis, Minnesota, 55454
Research Site
New York, New York, 10029
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Salt Lake City, Utah, 84113
Research Site
San Antonio, Texas, 78229
Research Site
St Louis, Missouri, 63104
Research Site
St Louis, Missouri, 63110
Research Site
The Bronx, New York, 10467
Research Site
West Orange, New Jersey, 07052
Research Site
Wilmington, Delaware, 19803
France7 sites
Research Site
Bron, 69677
Research Site
Lille, 59800
Research Site
Marseille, 13385
Research Site
Nice, 06202
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
Germany3 sites
Research Site
Hanover, 30625
Research Site
Heidelberg, 69120
Research Site
Marburg, 35043
Italy3 sites
Research Site
Genova, 16147
Research Site
Naples, 80129
Research Site
Torino, 10126
Poland3 sites
Research Site
Krakow, 30-663
Research Site
Lodz, 93-338
Research Site
Warsaw, 00-576
Russia3 sites
Research Site
Moscow, 107014
Research Site
Saint Petersburg, 198205
Research Site
Samara, 443095
Spain2 sites
Research Site
Barcelona, Catalonia, 08035
Research Site
Espluques de LLobregat, Catalonia, 08950
About this study
Official title: A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
Read the detailed description
This was a 24-week, randomized, multicenter, open-label, controlled study. Participants were randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment, or standard of care alone. Randomization was stratified by age group (6 to < 12 and 12 to < 18 years of age). All participants received standard of care which could include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders.
Participants in both treatment groups who completed the 20-week treatment period and those who ended the study due to study closure were eligible to enroll in an open-label extension study (20140159; NCT02341417) for further safety follow-up.
- Being tested
- Cinacalcet HCl, Standard of Care
- Keywords
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Dialysis, 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 HClDrug
Also called Sensipar®, Mimpara®
Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets.
Standard of CareDietary supplement
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders. Receives: Dietary Supplement: Standard of Care |
| Cinacalcet | Experimental | In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels. Receives: Drug: Cinacalcet HCl; Dietary Supplement: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15
Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated.
This endpoint was the primary endpoint in the US only.
Measured: Baseline and weeks 11 to 15
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period
Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated.
This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint.
Measured: Baseline and the efficacy assessment period (EAP), weeks 17 to 20
Secondary outcomes (4)
Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20
Measured: Efficacy assessment period, weeks 17 to 20
Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20
Measured: Baseline and weeks 17 to 20
Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20
Measured: Baseline and weeks 17 to 20
Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20
Measured: Baseline and weeks 17 to 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study start7 Nov 2014
- Primary completion23 Jun 2016
- Study completion23 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 Disease, Secondary HyperparathyroidismStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 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
- NCT02138838
- Sponsor's protocol ID
- 20130356
- Other IDs
- 2013-004958-18
- Status last verified
- Jun 2020
- First submitted
- 1 Apr 2014
- Last updated
- 29 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
- ClinicalTrials.gov ID
- NCT02138838
- Acronym / sponsor ID
- 20130356
- Keywords
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Dialysis, Pediatric
- Phase
- Phase 3
- 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
- 55 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2014 (actual)
- Primary completion
- 23 Jun 2016 (actual)
- Study completion
- 23 Jun 2016 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Posted 14 Sep 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 evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
Detailed description
This was a 24-week, randomized, multicenter, open-label, controlled study. Participants were randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment, or standard of care alone. Randomization was stratified by age group (6 to < 12 and 12 to < 18 years of age). All participants received standard of care which could include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders.
Participants in both treatment groups who completed the 20-week treatment period and those who ended the study due to study closure were eligible to enroll in an open-label extension study (20140159; NCT02341417) for further safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Dietary Supplement: Standard of CareStandard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders. |
| Cinacalcet | Experimental | Drug: Cinacalcet HCl, Dietary Supplement: Standard of CareIn addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6 - < 18 years
- Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values ≥ 300 pg/mL during screening
- Corrected calcium value of ≥ 8.8 mg/dL during screening
- Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days prior to screening
- Parent or legally acceptable representative has provided written informed consent and subject has provided written assent when required by institutional guidelines
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 cytochrome P450 3A4 (CYP3A4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
- Use of concomitant medications that may prolong the QTc interval (eg, 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 HClAlso: Sensipar®, Mimpara®Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets. | Drug | Cinacalcet |
| Standard of CareStandard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders. | Dietary supplement | Cinacalcet, Standard of Care |
Primary outcome
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15
Time frame: Baseline and weeks 11 to 15
Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated. This endpoint was the primary endpoint in the US only.
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period
Time frame: Baseline and the efficacy assessment period (EAP), weeks 17 to 20
Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated. This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint.
4 secondary outcomes
Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20
Time frame: Efficacy assessment period, weeks 17 to 20
Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20
Time frame: Baseline and weeks 17 to 20
Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20
Time frame: Baseline and weeks 17 to 20
Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20
Time frame: Baseline and weeks 17 to 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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
60 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cinacalcet HCl in people with Chronic Kidney Disease, Secondary Hyperparathyroidism, run by Amgen at 60 sites in 16 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 5 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 29 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 60 sites in United States, France, Belgium, Germany, Italy and 11 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 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 14 Sep 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 Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15 (time frame: Baseline and weeks 11 to 15). The study lists 2 primary outcomes in all. 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 NCT02138838, 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 29 Jun 2020.