Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
17. april 2013 oppdatert av: AbbVie (prior sponsor, Abbott)
This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism.
The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
255
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Aichi, Japan
- Site Reference ID/Investigator# 53485
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Chiba, Japan
- Site Reference ID/Investigator# 51571
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Chiba, Japan
- Site Reference ID/Investigator# 52963
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Chiba, Japan
- Site Reference ID/Investigator# 52966
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Gifu, Japan
- Site Reference ID/Investigator# 51578
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Gunma, Japan
- Site Reference ID/Investigator# 52965
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Hadano-City, Japan
- Site Reference ID/Investigator# 53782
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Himeji-City, Japan
- Site Reference ID/Investigator# 57483
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Hokkaido, Japan
- Site Reference ID/Investigator# 57487
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Hyogo, Japan
- Site Reference ID/Investigator# 53484
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Ibaraki, Japan
- Site Reference ID/Investigator# 54385
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Kagawa, Japan
- Site Reference ID/Investigator# 51581
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Kagoshima, Japan
- Site Reference ID/Investigator# 59164
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Kanagawa, Japan
- Site Reference ID/Investigator# 51574
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Kanagawa, Japan
- Site Reference ID/Investigator# 51575
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Kodaira, Japan
- Site Reference ID/Investigator# 52751
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Koga, Japan
- Site Reference ID/Investigator# 62025
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Matsumoto, Japan
- Site Reference ID/Investigator# 54384
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Midori, Japan
- Site Reference ID/Investigator# 52745
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Mito, Japan
- Site Reference ID/Investigator# 51569
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Nagano, Japan
- Site Reference ID/Investigator# 52964
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Nagano, Japan
- Site Reference ID/Investigator# 53483
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Nagasaki, Japan
- Site Reference ID/Investigator# 51582
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Nagoya, Japan
- Site Reference ID/Investigator# 54388
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Niigata, Japan
- Site Reference ID/Investigator# 51576
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Niigata, Japan
- Site Reference ID/Investigator# 51577
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Osaka, Japan
- Site Reference ID/Investigator# 51580
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Osaka, Japan
- Site Reference ID/Investigator# 52747
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Osaka, Japan
- Site Reference ID/Investigator# 52748
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Osaka, Japan
- Site Reference ID/Investigator# 52750
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Saitama, Japan
- Site Reference ID/Investigator# 51570
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Sakai, Japan
- Site Reference ID/Investigator# 54387
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Sapporo, Japan
- Site Reference ID/Investigator# 52746
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Shizuoka, Japan
- Site Reference ID/Investigator# 51579
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Takasaki, Japan
- Site Reference ID/Investigator# 62024
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Tokyo, Japan
- Site Reference ID/Investigator# 51572
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Tokyo, Japan
- Site Reference ID/Investigator# 52752
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Tokyo, Japan
- Site Reference ID/Investigator# 53482
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Tokyo, Japan
- Site Reference ID/Investigator# 59162
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Tokyo, Japan
- Site Reference ID/Investigator# 59966
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Tomakomai-shi, Japan
- Site Reference ID/Investigator# 53783
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Toyama, Japan
- Site Reference ID/Investigator# 54383
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Wakayama, Japan
- Site Reference ID/Investigator# 52749
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Yachiyoshi, Japan
- Site Reference ID/Investigator# 52962
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Yokohama-Shi, Japan
- Site Reference ID/Investigator# 59163
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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
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders
- On three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus (P) less than or equal to 6.5 mg/dL.
Exclusion Criteria:
- Patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes
- Patients who have received a parathyroidectomy or ethanol infusion within the prior year
- Patients taking drugs that affect iPTH, calcium or bone metabolism
- Patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
- Female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Paricalcitol
Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks.
After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
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Andre navn:
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Aktiv komparator: Maxacalcitol
Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks.
After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia
Tidsramme: iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).
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The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase.
Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.
iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
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iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia
Tidsramme: Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).
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The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase.
iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.
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Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).
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Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)
Tidsramme: The last three weeks of treatment (Weeks 11, 12, and 13)
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The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment.
iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
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The last three weeks of treatment (Weeks 11, 12, and 13)
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Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
Tidsramme: Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)
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The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment.
iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
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Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)
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Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
Tidsramme: Weeks 2 to 13
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iPTH control was defined as a ≥ 50% reduction from baseline.
iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory.
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Weeks 2 to 13
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Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL
Tidsramme: Weeks 2 to 13
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iPTH control was defined as being within the target range of 60 to 180 pg/mL.
iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory.
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Weeks 2 to 13
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Kazuya Kobayashi, BA, AbbVie GK.
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.
Hjelpsomme linker
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 2011
Primær fullføring (Faktiske)
1. april 2012
Studiet fullført (Faktiske)
1. april 2012
Datoer for studieregistrering
Først innsendt
25. april 2011
Først innsendt som oppfylte QC-kriteriene
25. april 2011
Først lagt ut (Anslag)
26. april 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. juni 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. april 2013
Sist bekreftet
1. april 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer
- Urologiske sykdommer
- Sykdommer i det endokrine systemet
- Nyreinsuffisiens
- Parathyreoidea sykdommer
- Neoplastiske prosesser
- Nyresykdommer
- Nyresvikt, kronisk
- Hyperparatyreose
- Neoplasma Metastase
- Hyperparathyroidisme, sekundær
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Beskyttende agenter
- Dermatologiske midler
- Mikronæringsstoffer
- Membrantransportmodulatorer
- Vitaminer
- Bone Density Conservation Agents
- Kalsiumregulerende hormoner og midler
- Antikreftfremkallende midler
- Vasokonstriktormidler
- Kalsiumkanalagonister
- Ergocalciferoler
- Kalsitriol
- Maxacalcitol
Andre studie-ID-numre
- M11-517
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. .