JOURNAL ONKOLOGIE – STUDIE
A Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Rekrutierend
NCT-Nummer:
NCT03969329
Studienbeginn:
Dezember 2019
Letztes Update:
14.01.2021
Wirkstoff:
Etelcalcetide
Indikation (Clinical Trials):
Neoplasm Metastasis, Hyperparathyroidism, Hyperparathyroidism, Secondary
Geschlecht:
Alle
Altersgruppe:
Kinder (0-17)
Phase:
Phase 3
Sponsor:
Amgen
Collaborator:
-
Studienleiter
Study Director
Amgen
Kontakt
Kontakt:
Phone: 866-572-6436
E-Mail: medinfo@amgen.com» Kontaktdaten anzeigen
Studienlocations
(3 von 17)
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
30625 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
9000 Gent
BelgiumRekrutierend» Google-Maps
150 06 Praha 5
CzechiaRekrutierend» Google-Maps
69677 Bron cedex
FranceRekrutierend» Google-Maps
75012 Paris
FranceRekrutierend» Google-Maps
11527 Athens
GreeceRekrutierend» Google-Maps
54642 Thessaloniki
GreeceRekrutierend» Google-Maps
1083 Budapest
HungaryRekrutierend» Google-Maps
6720 Szeged
HungaryRekrutierend» Google-Maps
50139 Firenze
ItalyRekrutierend» Google-Maps
08406 Vilinus
LithuaniaRekrutierend» Google-Maps
30-663 Krakow
PolandRekrutierend» Google-Maps
08035 Barcelona
SpainRekrutierend» Google-Maps
G51 4TF Glasgow
United KingdomRekrutierend» Google-Maps
WC1N 3JH London
United KingdomRekrutierend» Google-Maps
Studien-Informationen
Brief Summary:Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide
in the treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects between ≥ 2 to
< 18 years of age, with chronic kidney disease (CKD) on hemodialysis
Ein-/Ausschlusskriterien
Inclusion Criteria:- 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-specific activities/procedures being initiated.
- Male or female subjects greater than or equal to 2 to less than 18 years of age at the
time of enrollment.
- Targeted Dry weight greater than or equal to 7 kg at the time of screening Week -1.
- Diagnosed with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT)
undergoing hemodialysis/hemodiafiltration three times per week (TIW) at the time of
screening greater than or equal to 1 month.
- Diagnosis of secondary hyperparathyroidism (SHPT) with the mean of the 2 consecutive
central laboratory intact parathyroid hormone (iPTH) values greater than 300 pg/mL
during screening, on separate days and within 2 weeks of enrollment obtained from the
central laboratory during screening.
- Serum corrected calcium (cCa) value greater than or equal to 9.0 mg/dL obtained from
the central laboratory during screening.
- Dialysate calcium (Ca) level greater than or equal to 2.5 mEq/L for at least 1 month
prior to screening and throughout the duration of the study.
- Subject receiving active vitamin D sterols must have had no more than a maximum dose
change of 50% within the 2 weeks prior to screening laboratory assessments, remain
stable through enrollment, and be expected to maintain stable doses for the duration
of the study, except for adjustments allowed per protocol.
- Subject receiving phosphate binders must have had no more than a maximum dose change
of 50% within the 2 weeks prior to screening laboratory assessments, remain stable
through enrollment, and be expected to maintain stable dose for the duration of the
study, except for adjustments allowed per protocol.
- Subject receiving calcium (Ca) supplements must have had no more than a maximum dose
change of 50% within the 2 weeks prior to screening laboratory assessments, remain
stable through enrollment, and be expected to maintain stable dose for the duration of
the study, except for adjustments allowed per protocol.
- Secondary hyperparathyroidism (SHPT) not due to vitamin D deficiency, per investigator
assessment.
Exclusion Criteria:
- Disease Related:
- History of congenital long QT syndrome, second or third degree heart block,
ventricular tachyarrhythmia's, history of symptomatic ventricular dysrhythmias
Torsades de Pointes or other conditions associated with prolonged QT interval.
- Anticipated or scheduled parathyroidectomy during the study period.
- Anticipated or scheduled kidney transplant during the study period.
- Subject has received a parathyroidectomy within 6 months prior to enrollment.
- Other Medical Conditions:
- Current malignancy or history of other malignancy, except non-melanoma skin cancers
within the last 5 years.
- Prior/Concomitant Therapy:
- Use of concomitant medications that may prolong the QTc (eg, ondansetron, albuterol,
sotalol, amiodarone, erythromycin, or clarithromycin). Refer to CredibleMeds.org for
guidance.
- Receipt of cinacalcet therapy within 30 days prior to screening and through
enrollment.
- Any previous use of etelcalcetide prior to screening and through enrollment.
- All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the
subject within the 30 days prior to enrollment, and continuing use if applicable, will
be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written
documentation of the review and Amgen acknowledgment is required for subject
participation.
- Use of any over-the-counter or prescription medications within the 14 days or 5
half-lives (whichever is longer) prior to enrollment that are not established
therapies for subjects with renal disease or other conditions secondary to renal
disease will be reviewed by the Principal Investigator and the Amgen Medical Monitor.
Written documentation of the review and Amgen acknowledgment is required for subject
participation. Paracetamol (up to 2 g per day) for analgesia will be allowed.
- Prior/Concurrent Clinical Study Experience:
- 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(ies). Other investigational procedures while participating in this study are
excluded.
- Diagnostic Assessments During Screening:
- Subject has significant abnormalities on the most recent central laboratory test
during the screening period prior to enrollment per the Investigator including but not
limited to the following: a. Serum transaminase (alanine aminotransferase [ALT] or
serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST], or serum
glutamic oxaloacetic transaminase [SGOT]) greater than 1.5 times the upper limit of
normal (ULN).
- Corrected QT interval greater than 500 ms, using Bazett's formula.
- Corrected QT interval greater than or equal to 450 to less than or equal to 500 ms,
using Bazett's formula, unless written permission to enroll is provided by the
investigator after consultation with a pediatric cardiologist.
- Subject has a clinically significant electrocardiogram (ECG) abnormality (eg, unstable
arrhythmia) during screening that, in the opinion of the investigator, could pose a
risk to subject safety or interfere with the study evaluation.
- Within the 3 Months Prior to Screening:
- New onset or worsening of a pre-existing seizure disorder.
- Subjects on anti-convulsant medication must be on a stable and therapeutic dose for 3
months prior to screening (if blood level monitoring is clinically available, then the
subject must have a therapeutic blood level within 1 week of enrollment).
Other Exclusions:
- Female subject is pregnant or breastfeeding or planning to become pregnant or
breastfeed during treatment and for an additional 3 months after the last dose of
etelcalcetide. (Females of childbearing potential should only be included in the study
after a confirmed menstrual period and a negative serum pregnancy test within 7 days
prior to the first dose of investigational product).
- Female subjects of childbearing potential unwilling to use 1 acceptable method of
effective contraception during treatment and for an additional 3 months after the last
dose of investigational product. Refer to Appendix 5 for additional contraceptive
information.
- Female subjects of childbearing potential with a positive pregnancy test assessed at
screening by a serum pregnancy test.
- Subject has known sensitivity to etelcalcetide or excipients 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 to the best of the
subject and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition or disease
(with the exception of those outlined above) or unacceptable physical findings, 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 or previously received treatment with
etelcalcetide.
- Anemia, which in the opinion of the investigator makes it not advisable to undergo
sequential blood draws.
- History of unstable chronic heart failure within the last 1 year prior to screening.
Studien-Rationale
Primary outcome:1. Percent change in intact parathyroid hormone (iPTH) from baseline during the efficacy assessment period (EAP) at weeks 20 to 26 (Time Frame - 20 to 26 weeks):
To evaluate the efficacy of etelcalcetide in reducing the intact parathyroid hormone (iPTH) level in children ages equal to or greater than 2 to less than 18 years with secondary hyperparathyroidism (SHPT) receiving maintenance hemodialysis
Secondary outcome:
1. Achievement of a greater than 30% reduction from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment period (EAP) (Time Frame - 20 to 26 weeks):
To evaluate the efficacy of etelcalcetide
2. Percent change from baseline in corrected total serum calcium (Ca) and serum phosphorus from baseline during the EAP (Time Frame - 20 to 26 weeks):
To characterize change in laboratory markers of chronic kidney disease
3. Proportion of subjects achieving corrected serum calcium (Ca) levels less than 8.0 mg/dL (2.0 mmol/L) at any time during the study (Time Frame - 20 to 26 weeks):
To characterize the safety of etelcalcetide treatment based on laboratory values
4. Proportion of subjects with changes in laboratory parameters, including clinical chemistry (Time Frame - 20 to 26 weeks):
To characterize the safety of etelcalcetide treatment based on laboratory values
5. Proportion of subjects with hypocalcemia (corrected serum calcium levels less than 8.4 mg/dL) (Time Frame - 20 to 26 weeks):
To characterize the safety of etelcalcetide treatment based on laboratory values
6. Etelcalcetide plasma concentrations before and at the end of dialysis after single and multiple doses (Time Frame - 20 to 26 weeks):
Etelcalcetide plasma concentrations before and at the end of dialysis after single and multiple doses
7. Etelcalcetide PK parameter of maximum-observed concentration (Cmax) (Time Frame - 20 to 26 weeks):
Etelcalcetide plasma concentrations before and at the end of dialysis after single and multiple doses
8. Etelcalcetide pharmacokinetic (PK) parameter of plasma trough concentrations (Cmin) (Time Frame - 20 to 26 weeks):
To characterize the pharmacokinetic (PK) of etelcalcetide treatment after single and multiple doses
9. Subject incidence of all treatment-emergent adverse events (Time Frame - 20 to 26 weeks):
To characterize the safety of etelcalcetide treatment based on adverse events. Nature, frequency, severity, and relationship to treatment of all adverse events, including those of special interest reported during the study
Geprüfte Regime
- Etelcalcetide (Parsabiv - brand name):
Etelcalcetide has been shown to be safe and efficacious in treating adult chronic kidney disease (CKD) patients with secondary hyperparathyroidism (SHPT) by simultaneously controlling intact parathyroid hormone (iPTH), calcium (Ca), and phosphorus and has recently been approved for use in adult patients with secondary hyperparathyroidism (SHPT) treated with hemodialysis in both the United States and Europe
Quelle: ClinicalTrials.gov
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