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Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

20. december 2011 opdateret af: Abbott

A Phase 3b, Randomized, Active-Controlled, Single-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Injection in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects Receiving Hemodialysis

Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

216

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina, 100034
        • Site Reference ID/Investigator# 23483
      • Beijing, Kina, 100044
        • Site Reference ID/Investigator# 23485
      • Beijing, Kina, 100730
        • Site Reference ID/Investigator# 23482
      • Dalian City, Kina, 116011
        • Site Reference ID/Investigator# 23484
      • Guangzhou City, Kina, 510080
        • Site Reference ID/Investigator# 23486
      • Nanjing, Kina, 210029
        • Site Reference ID/Investigator# 23488
      • Qingdao, Kina, 266003
        • Site Reference ID/Investigator# 37722
      • Shanghai, Kina, 200001
        • Site Reference ID/Investigator# 23490
      • Shanghai, Kina, 200001
        • Site Reference ID/Investigator# 25502
      • Shanghai, Kina, 200025
        • Site Reference ID/Investigator# 23489
      • Shanghai, Kina, 200092
        • Site Reference ID/Investigator# 23487
      • Wenzhou, Kina, 325000
        • Site Reference ID/Investigator# 35822

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Subject is a Chinese male or female greater than or equal to 20 years old.
  2. Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemodialysis for the duration of the study.

  3. For entry into the Treatment Phase, the subject must have:

    • Intact parathyroid hormone greater than or equal to 300 pg/mL
    • Serum calcium less than 10.2 mg/dL (2.55 mmol/L)
    • Calcium-phosphorus product less than 65 mg^2/dL^2

Exclusion Criteria:

  1. Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
  2. Subject received a partial parathyroidectomy within one year prior to the Screening Phase.
  3. Subject with New York Heart Association (NYHA) Class III or IV.
  4. Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the Screening Phase, or requires such medications for greater than 3 weeks in the study.
  5. Subject has a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the Investigator.
  6. Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
  7. Subject is known to be human immunodeficiency virus (HIV) positive.
  8. Subject has evidence of poor compliance with diet, medication or hemodialysis that may interfere, in the Investigator's opinion, with adherence to the protocol.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group 1
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Medicin: paricalcitol
Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.
Andre navne:
  • Zemplar
  • ABT-358
Aktiv komparator: Group 2
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Medicin: paricalcitol
Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.
Andre navne:
  • Zemplar
  • ABT-358

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels
Tidsramme: Baseline to 12 Weeks
The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values
Baseline to 12 Weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL
Tidsramme: Baseline to 12 Weeks
The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value
Tidsramme: Baseline to 12 Weeks
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium
Tidsramme: Baseline to 12 Weeks
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium-phosphorus Product
Tidsramme: Baseline to 12 Weeks
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure
Tidsramme: Baseline to 12 Weeks
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure
Tidsramme: Baseline to 12 Weeks
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate
Tidsramme: Baseline to 12 Weeks
Baseline to 12 Weeks
The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)
Tidsramme: Baseline to 12 weeks
The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)
Baseline to 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abbott

Efterforskere

  • Studieleder: Yue Kang, MD, Abbott (China)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2009

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

25. november 2009

Først indsendt, der opfyldte QC-kriterier

17. februar 2010

Først opslået (Skøn)

19. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. januar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. december 2011

Sidst verificeret

1. december 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M06-823

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kronisk nyresygdom

Kliniske forsøg med paricalcitol

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Germany

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner