Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
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| ClinicalTrials.gov Identifier: NCT02138838 |
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Recruitment Status :
Terminated
(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.)
First Posted : May 15, 2014
Results First Posted : September 14, 2017
Last Update Posted : June 29, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Kidney Disease, Secondary Hyperparathyroidism | Drug: Cinacalcet HCl Dietary Supplement: Standard of Care | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 55 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | November 7, 2014 |
| Actual Primary Completion Date : | June 23, 2016 |
| Actual Study Completion Date : | June 23, 2016 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
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Dietary Supplement: Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders. |
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Experimental: Cinacalcet
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.
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Drug: Cinacalcet HCl
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.
Other Names:
Dietary Supplement: Standard of Care Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders. |
- 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.
- 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 ]
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| Ages Eligible for Study: | 6 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138838
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| Study Director: | MD | Amgen |
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT02138838 |
| Other Study ID Numbers: |
20130356 2013-004958-18 ( EudraCT Number ) |
| First Posted: | May 15, 2014 Key Record Dates |
| Results First Posted: | September 14, 2017 |
| Last Update Posted: | June 29, 2020 |
| Last Verified: | June 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Chronic Kidney Disease, Secondary Hyperparathyroidism, Dialysis, Pediatric |
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Neoplasm Metastasis Kidney Diseases Renal Insufficiency, Chronic Hyperparathyroidism Hyperparathyroidism, Secondary Urologic Diseases Neoplastic Processes Neoplasms Pathologic Processes |
Renal Insufficiency Parathyroid Diseases Endocrine System Diseases Cinacalcet Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Calcimimetic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |