Phase 1
Completed N=14
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
Chronic Kidney Disease · Hyperparathyroidism, Secondary · Hyperparathyroidism
Source: ClinicalTrials.gov NCT01290029 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Number of Participants With Adverse Events — 3; 0; 0; 0 participants
Summary
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
3; 0; 0; 0; 1; 1 | — |
| SECONDARY Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet |
11.8 | — |
| SECONDARY Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet |
11.3 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Cinacalcet |
2.83 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax) |
1.0 | — |
| SECONDARY Terminal Half-life of Cinacalcet |
3.70 | — |
| SECONDARY Percent Change From Baseline in Intact Parathyroid Hormone |
-10.80; -29.6; 29.40; -5.40 | — |
| SECONDARY Percent Change From Baseline in Total Calcium |
-4.33; -6.38; -6.63; -4.54 | — |
| SECONDARY Percent Change From Baseline in Albumin Corrected Calcium |
-4.01; -7.12; -4.24; -4.10 | — |
| SECONDARY Percent Change From Baseline in Ionized Calcium |
-1.77; -4.20; -4.15; -1.45 | — |
Eligibility Criteria
Inclusion Criteria
- Subject's parent, or legally acceptable guardian, must sign an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved Informed Consent Form.
- Subjects 28 days to 500 ms during screening, using Bazett's formula
- QTc ≥ 450 and ≤ 500 ms during screening, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
- Known hypersensitivity to cinacalcet HCl or any of the excipients in cinacalcet HCl.
- Use of grapefruit juice, herbal medications or potent CYP 3A4 inhibitors (eg, erythromycin, clarithromycin, ketokonazole, itraconazole) within the 14 days prior to enrollment and during the study.
- Concurrent or within 28 days prior to enrollment use of medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (eg, flecainide, vinblastine, thioridazine, tricyclic antidepressants such as desipramine and imipramine, and beta-blockers such as metoprolol or carvedilol).
- Concurrent or within 28 days prior to enrollment use of medications that prolong QT interval (eg, sotalol, amiodarone, erythromycin, or clarithromycin).
- Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(s).
- Other investigational procedures while participating in this study are excluded.
Data sourced from ClinicalTrials.gov (NCT01290029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.