Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
1 marzo 2017 aggiornato da: KAI Pharmaceuticals
A Double-Blind, Randomized, Placebo-Controlled Multiple Ascending Dose Study to Assess the Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism
The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
87
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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California
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Azusa, California, Stati Uniti, 91702
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Costa Mesa, California, Stati Uniti, 92626
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Lynwood, California, Stati Uniti, 90262
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Riverside, California, Stati Uniti, 92505
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San Diego, California, Stati Uniti, 92123
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Colorado
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Denver, Colorado, Stati Uniti, 80218
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Georgia
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Macon, Georgia, Stati Uniti, 31217
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Louisiana
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Shreveport, Louisiana, Stati Uniti, 71101
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Minnesota
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Brooklyn Center, Minnesota, Stati Uniti, 55430
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19106
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Texas
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Houston, Texas, Stati Uniti, 77004
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Houston, Texas, Stati Uniti, 77099
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Virginia
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Chesapeake, Virginia, Stati Uniti, 23320
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Subject provides written informed consent.
- Intact parathyroid hormone (PTH) at least 350 pg/mL.
- Corrected calcium at least 9.0 mg/dL.
- Hemoglobin at least 9.0 g/dL.
- Adequate hemodialysis three times per week.
- Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests.
Exclusion Criteria:
- History or symptomatic ventricular dysrhythmias.
- History of angina pectoris or congestive heart failure
- History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months.
- History of or treatment for seizure disorder.
- Recent (3 months) parathyroidectomy.
- Serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater than two times the upper limit of normal at screening.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Etelcalcetide
Participants received etelcalcetide administered by intravenous injection at the end of each hemodialysis session three times a week (TIW).
The starting dose level was 5 mg; dose escalation was to proceed to 10 and 20 mg pending safety review of the prior cohort.
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Administered intravenously (IV) at the end of hemodialysis
Altri nomi:
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Comparatore placebo: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW).
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Administered intravenously at the end of hemodialysis
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase
Lasso di tempo: Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
|
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1.
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
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Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase
Lasso di tempo: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
|
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1.
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
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Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
Lasso di tempo: Efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
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Efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase
Lasso di tempo: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
|
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1.
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
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Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Percent Change From Baseline in Mean Phosphorus (P) During the Efficacy Assessment Phase
Lasso di tempo: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
|
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1.
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
|
Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Percent Change From Baseline in Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase
Lasso di tempo: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
|
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1.
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
|
Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase
Lasso di tempo: Efficacy assessment phase
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Efficacy assessment phase
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: M D, Amgen
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
20 febbraio 2011
Completamento primario (Effettivo)
1 luglio 2011
Completamento dello studio (Effettivo)
24 agosto 2011
Date di iscrizione allo studio
Primo inviato
3 dicembre 2010
Primo inviato che soddisfa i criteri di controllo qualità
3 dicembre 2010
Primo Inserito (Stima)
6 dicembre 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 aprile 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 marzo 2017
Ultimo verificato
1 marzo 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KAI-4169-003
- 20120330 (Altro identificatore: Amgen, Inc)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .