| Trial ID: | L0640 |
| Source ID: | NCT02341417
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| Associated Drug: |
Cinacalcet
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| Title: |
Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT02341417/results
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| Conditions: |
Secondary Hyperparathyroidism, Chronic Kidney Disease
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| Interventions: |
DRUG: Cinacalcet
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| Outcome Measures: |
Primary: 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?, From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks. | Secondary: 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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).
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| Sponsor/Collaborators: |
Sponsor: Amgen
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| Gender: |
ALL
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| Age: |
CHILD, ADULT
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| Phases: |
PHASE3
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| Enrollment: |
28
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2015-06-10
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| Completion Date: |
2017-03-15
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| Results First Posted: |
2018-05-18
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| Last Update Posted: |
2020-06-29
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| Locations: |
Research Site, Los Angeles, California, 90027, United States|Research Site, Tucker, Georgia, 30084, United States|Research Site, Baltimore, Maryland, 21287, United States|Research Site, Boston, Massachusetts, 02115, United States|Research Site, Minneapolis, Minnesota, 55454, United States|Research Site, Jackson, Mississippi, 39216, United States|Research Site, Kansas City, Missouri, 64108, United States|Research Site, Saint Louis, Missouri, 63110, United States|Research Site, West Orange, New Jersey, 07052, United States|Research Site, New York, New York, 10029, United States|Research Site, Greenville, North Carolina, 27834, United States|Research Site, Cincinnati, Ohio, 45229, United States|Research Site, Cleveland, Ohio, 44195, United States|Research Site, Columbus, Ohio, 43205, United States|Research Site, Oklahoma City, Oklahoma, 73104, United States|Research Site, Dallas, Texas, 75235, United States|Research Site, Houston, Texas, 77030, United States|Research Site, Salt Lake City, Utah, 84113, United States|Research Site, Bruxelles, 1020, Belgium|Research Site, Praha 5, 150 06, Czechia|Research Site, Paris, 75015, France|Research Site, Hannover, 30625, Germany|Research Site, Heidelberg, 69120, Germany|Research Site, Marburg, 35043, Germany|Research Site, Athens, 11527, Greece|Research Site, Szeged, 6720, Hungary|Research Site, Genova, 16147, Italy|Research Site, Krakow, 30-663, Poland|Research Site, Lodz, 93-338, Poland|Research Site, Moscow, 107014, Russian Federation|Research Site, Saint Petersburg, 198205, Russian Federation|Research Site, Samara, 443095, Russian Federation|Research Site, Kyiv, 01135, Ukraine
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| URL: |
https://clinicaltrials.gov/show/NCT02341417
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