Secondary Hyperparathyroidism, Chronic Kidney DiseasePhase 3NCT02341417
Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis
A Phase 3 study testing Cinacalcet in people with Secondary Hyperparathyroidism, Chronic Kidney Disease, run by Amgen at 33 sites in 11 countries.
Trial summary
The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- 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
- 28 participants
- Where
- 33 sitesin 11 countries
- Study dates
- 10 Jun 2015to 15 Mar 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All subjects:
- Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any Study 20140159 activities/procedures being initiated.
- Dialysate calcium concentration ≥ 2.5 mEq/L at day 1
- All subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and screening for Study 20140159:
- Subjects on anti-convulsant medication must be on a stable dose
- All subjects from 20130356:
Show all 14Show fewer
- Completed treatment through week 20 in the 20130356 study or on study at the time of Study 20130356 termination
- Dry weight ≥ 12.5 kg at day 1 of Study 20140159
- Subjects Randomized to the 20130356 Standard of Care Arm Only:
- intact parathyroid hormone (iPTH) value ≥ 300 pg/mL (within 7 days of day 1 in Study 20140159)
- Corrected calcium value ≥ 8.8 mg/dL within 7 days of day 1 in Study 20140159
- All Subjects from 20110100:
- Completed week 26 End of Study visit in the, 20110100 study or on study at the time of Study 20110100 termination
- Dry weight ≥ 7 kg at day 1 of Study 20140159
Who cannot join
- General (studies 20130356 and 20110100):
- 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), other than Amgen Studies 20130356 or 20110100.
- Other investigational procedures while participating in this study are excluded.
- Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
- Subject has known sensitivity to any of the products to be administered during dosing.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary [ediary]) to the best of the subject and investigator's knowledge
Show all 25Show fewer
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Subject previously has entered this study.
- If sexually active, subject is not willing to use acceptable contraception during treatment and for at least 9 days after the end of treatment.
- Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment
- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias, or other conditions associated with prolonged QT interval
- A new onset of seizures or worsening of pre-existing seizure disorder
- All Subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and the screening visit in Study 20140159 will have the following exclusion criteria applied during screening and day 1:
- Unstable chronic heart failure defined as worsening pulmonary edema or other signs and symptoms as per investigator assessment during screening
- Received therapy with commercial cinacalcet after the last study visit in Study 20130356 or Study 20110100 before day 1 of Study 20140159
- Scheduled date for kidney transplantation from a known living donor that makes completion of the study unlikely
- Either new or recurrent cardiac ventricular arrhythmias requiring a change in treatment within 10 days prior to screening visit or day 1 of Study 20140159 screening
- Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase [AST] ≥ 1.5 × upper limit of normal [ULN] OR alanine aminotransferase [ALT] ≥ 1.5 × ULN OR total bilirubin ≥ 1 × ULN per institutional laboratory range) during screening
- All Subjects - Day 1 Study Visit:
- Subject has an ongoing adverse event from Studies 20130356 or 20110100 that is considered related to investigational product and is ≥ Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0) grade 3, and/or considered clinically significant in the opinion of the investigator
- Central laboratory values were not obtained/are not available at day 1 in Study 20140159
- 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, CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole), or CYP2D6 substrates (eg, flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine)
- Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
Trial locations and contacts
33 sites in 11 countries.
33 sites in 11 countries
United States18 sites
Research Site
Baltimore, Maryland, 21287
Research Site
Boston, Massachusetts, 02115
Research Site
Cincinnati, Ohio, 45229
Research Site
Cleveland, Ohio, 44195
Research Site
Columbus, Ohio, 43205
Research Site
Dallas, Texas, 75235
Research Site
Greenville, North Carolina, 27834
Research Site
Houston, Texas, 77030
Research Site
Jackson, Mississippi, 39216
Research Site
Kansas City, Missouri, 64108
Research Site
Los Angeles, California, 90027
Research Site
Minneapolis, Minnesota, 55454
Research Site
New York, New York, 10029
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Salt Lake City, Utah, 84113
Research Site
St Louis, Missouri, 63110
Research Site
Tucker, Georgia, 30084
Research Site
West Orange, New Jersey, 07052
Germany3 sites
Research Site
Hanover, 30625
Research Site
Heidelberg, 69120
Research Site
Marburg, 35043
Russia3 sites
Research Site
Moscow, 107014
Research Site
Saint Petersburg, 198205
Research Site
Samara, 443095
About this study
Official title: A Multicenter Single-arm Extension Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis
The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.
Read the detailed description
This extension study was designed to characterize the long-term safety and tolerability of cinacalcet in pediatric patients from Amgen Studies 20130356 (NCT02138838) and 20110100 (NCT01439867) who either had completed the parent study or were ongoing at the time an administrative decision was made to end the parent study. After enrolling into this study participants were administered cinacalcet for 28 weeks or until the time of renal transplant or parathyroidectomy, whichever occurred first. The treatment period was followed by a 4-week safety follow-up period.
- Being tested
- Cinacalcet
- Keywords
- Chronic Kidney Disease, Dialysis, Secondary Hyperparathyroidism, Pediatric
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinacalcetDrug
Also called Cinacalcet hydrochloride, Cinacalcet HCL, Sensipar®, Mimpara®
Cinacalcet was provided as 5 mg capsules for sprinkling or as 30 mg film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg.
| Study group | Role | What they receive |
|---|---|---|
| Cinacalcet | Experimental | Participants received cinacalcet daily for 24 weeks in this extension study. For participants who received standard of care (SOC) in parent study 20130356, the starting dose was 0.20 mg/kg/day. For participants who received SOC and cinacalcet in parent study 20130356 or 20110100 the starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study.
Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. 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
Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a "yes" or "no" response to the question: Is there a reasonable possibility that the event may have been caused by the study drug?
Measured: From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.
Secondary outcomes (13)
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15
This endpoint was analyzed in participants who received SOC only in parent study 20130356.
Participants who had no iPTH values during weeks 11 or 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Baseline (defined as the mean values of samples collected during the screening period and day 1 pre-dose in the extension study) and weeks 11 and 15
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28
This endpoint was analyzed in participants who received SOC only in parent study 20130356.
For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Extension study baseline and weeks 23 and 28
Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28
This endpoint was analyzed in participants who received SOC only in parent study 20130356.
For participants who had no values during week 23 and week 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Extension study baseline and weeks 23 and 28
Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28
For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Weeks 23 and 28
Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28
For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Extension study baseline and weeks 23 and 28
Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28
For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Extension study baseline and weeks 23 and 28
Serum Corrected Calcium at Baseline, Week 11, and Week 28
Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Extension study baseline, week 11 and week 28
Serum Phosphorus at Baseline, Week 11, and Week 28
Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Extension study baseline, week 11 and week 28
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15
The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356.
Participants who had no iPTH values during weeks 11 and 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment.
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28
The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356.
For participants who did not have an iPTH value during weeks 23 and 28, the mean of the last two available post-baseline values collected at protocol-specified visits was used. If only one post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Baseline and weeks 23 and 28, relative to day 1 of cinacalcet treatment.
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time
Percent change in iPTH measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.
Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time
Change in corrected calcium measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.
Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time
Change in phosphorus measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.
Data collected more than 7 days after the last dose of study drug were excluded.
Measured: Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study start10 Jun 2015
- Primary completion15 Mar 2017
- Study completion15 Mar 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary Hyperparathyroidism, 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT02341417
- Sponsor's protocol ID
- 20140159
- Other IDs
- 2014-003563-38, 2014
- Status last verified
- Jun 2020
- First submitted
- 2 Dec 2014
- Last updated
- 29 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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
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 Multicenter Single-arm Extension Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis
- ClinicalTrials.gov ID
- NCT02341417
- Acronym / sponsor ID
- 20140159
- Keywords
- Chronic Kidney Disease, Dialysis, Secondary Hyperparathyroidism, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Posted 18 May 2018
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 of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.
Detailed description
This extension study was designed to characterize the long-term safety and tolerability of cinacalcet in pediatric patients from Amgen Studies 20130356 (NCT02138838) and 20110100 (NCT01439867) who either had completed the parent study or were ongoing at the time an administrative decision was made to end the parent study. After enrolling into this study participants were administered cinacalcet for 28 weeks or until the time of renal transplant or parathyroidectomy, whichever occurred first. The treatment period was followed by a 4-week safety follow-up period.
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 cinacalcet daily for 24 weeks in this extension study. For participants who received standard of care (SOC) in parent study 20130356, the starting dose was 0.20 mg/kg/day. For participants who received SOC and cinacalcet in parent study 20130356 or 20110100 the starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any Study 20140159 activities/procedures being initiated.
- Dialysate calcium concentration ≥ 2.5 mEq/L at day 1
- All subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and screening for Study 20140159:
- Subjects on anti-convulsant medication must be on a stable dose
- Completed treatment through week 20 in the 20130356 study or on study at the time of Study 20130356 termination
Key exclusion criteria (25 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), other than Amgen Studies 20130356 or 20110100.
- Other investigational procedures while participating in this study are excluded.
- Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
- Subject has known sensitivity to any of the products to be administered during dosing.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary [ediary]) to the best of the subject and investigator's knowledge
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: Cinacalcet hydrochloride, Cinacalcet HCL, Sensipar®, Mimpara®Cinacalcet was provided as 5 mg capsules for sprinkling or as 30 mg film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg. | Drug | Cinacalcet |
Primary outcome
Number of Participants With Adverse Events
Time frame: From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.
Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a "yes" or "no" response to the question: Is there a reasonable possibility that the event may have been caused by the study drug?
13 secondary outcomes
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15
Time frame: Baseline (defined as the mean values of samples collected during the screening period and day 1 pre-dose in the extension study) and weeks 11 and 15
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28
Time frame: Extension study baseline and weeks 23 and 28
Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28
Time frame: Extension study baseline and weeks 23 and 28
Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28
Time frame: Weeks 23 and 28
Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28
Time frame: Extension study baseline and weeks 23 and 28
Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28
Time frame: Extension study baseline and weeks 23 and 28
Serum Corrected Calcium at Baseline, Week 11, and Week 28
Time frame: Extension study baseline, week 11 and week 28
Serum Phosphorus at Baseline, Week 11, and Week 28
Time frame: Extension study baseline, week 11 and week 28
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15
Time frame: Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment.
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28
Time frame: Baseline and weeks 23 and 28, relative to day 1 of cinacalcet treatment.
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time
Time frame: Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time
Time frame: Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time
Time frame: Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).
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 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
33 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cinacalcet in people with Secondary Hyperparathyroidism, Chronic Kidney Disease, run by Amgen at 33 sites in 11 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 14 inclusion and 25 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 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 33 sites in United States, Germany, Russia, Poland, Belgium and 6 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 18 May 2018). 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: From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 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 NCT02341417, which also lists 1 linked publication.
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.