- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00110890
A Research Study for Patients With End-Stage Renal Disease (ESRD)
11. februar 2011 oppdatert av: Amgen
An Open-Label, Randomised Study Using Cinacalcet to Improve Achievement of Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With ESRD
The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
552
Fase
- Fase 4
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
- The mean of 2 iPTH determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/mL (31.8 pmol/L) and less than 800 pg/mL (84.8 pmol/L). If biPTH is determined, the mean levels must be greater than or equal to 150 pg/mL (15.9 pmol/L) and less than 410 pg/mL (43.5 pmol/L)
- The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be greater than or equal to 8.4 mg/dL (2.1 mmol/L)
Exclusion Criteria:
- Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
- Have had a parathyroidectomy in the 6 months before day 1
- Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If subjects are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1.
- Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants). The tricyclic antidepressant amitriptyline is permitted. - Experienced a myocardial infarction within 3 months prior to day 1
- Are currently enrolled in, or have not yet completed at least 30 days before day 1, other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable)
- Have a gastrointestinal disorder that may be associated with impaired absorption or orally administered medications or an inability to swallow tablets
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Standard of care
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.
|
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.
|
Annen: Cinacalcet
Treatment with cinacalcet will be initiated at a dose of 30 mg/day.
Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg.
Dose escalation of cinacalcet may occur based on iPTH values.
|
Treatment with cinacalcet will be initiated at a dose of 30 mg/day.
Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Mean PTH ≤ 300 pg/mL
Tidsramme: Efficacy Assessment Phase (weeks 17 to 23)
|
Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase
|
Efficacy Assessment Phase (weeks 17 to 23)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL
Tidsramme: Efficacy Assesment Phase (weeks 17-23)
|
Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase
|
Efficacy Assesment Phase (weeks 17-23)
|
Number of Participants With Mean Ca x P < 55 mg^2/dL^2
Tidsramme: Efficacy Assessment Phase (weeks 17 to 23)
|
Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 during the efficacy assessment phase
|
Efficacy Assessment Phase (weeks 17 to 23)
|
Number of Participants With Mean Serum Ca < 9.5 mg/dL
Tidsramme: Efficacy Assessment Phase (weeks 17-23)
|
Number of participants with mean serum calcium (Ca) < 9.5 mg/dL during the efficacy assessment phase
|
Efficacy Assessment Phase (weeks 17-23)
|
Number of Participants With Mean Serum P < 5.5 mg/dL
Tidsramme: Efficacy Assessment Phase (weeks 17 to 23)
|
Number of participants with mean serum phosphorus (P) < 5.5 mg/dL during the efficacy assessment phase
|
Efficacy Assessment Phase (weeks 17 to 23)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Messa P, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazao JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Wilkie M, Zani VJ, Molemans B, Carter D, Locatelli F. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2008 Jan;3(1):36-45. doi: 10.2215/CJN.03591006.
- Wilkie M, Pontoriero G, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazao JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Zani VJ, Carter D, Messa P. Impact of vitamin D dose on biochemical parameters in patients with secondary hyperparathyroidism receiving cinacalcet. Nephron Clin Pract. 2009;112(1):c41-50. doi: 10.1159/000212102. Epub 2009 Apr 10.
- Frazao JM, Braun J, Messa P, Dehmel B, Mattin C, Wilkie M. Is serum phosphorus control related to parathyroid hormone control in dialysis patients with secondary hyperparathyroidism? BMC Nephrol. 2012 Aug 3;13:76. doi: 10.1186/1471-2369-13-76.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2004
Primær fullføring (Faktiske)
1. april 2005
Studiet fullført (Faktiske)
1. september 2007
Datoer for studieregistrering
Først innsendt
16. mai 2005
Først innsendt som oppfylte QC-kriteriene
16. mai 2005
Først lagt ut (Anslag)
17. mai 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
7. mars 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. februar 2011
Sist bekreftet
1. februar 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20030187
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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