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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

255

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Japan
      • Aichi, Japan
        • Site Reference ID/Investigator# 53485
      • Chiba, Japan
        • Site Reference ID/Investigator# 51571
      • Chiba, Japan
        • Site Reference ID/Investigator# 52963
      • Chiba, Japan
        • Site Reference ID/Investigator# 52966
      • Gifu, Japan
        • Site Reference ID/Investigator# 51578
      • Gunma, Japan
        • Site Reference ID/Investigator# 52965
      • Hadano-City, Japan
        • Site Reference ID/Investigator# 53782
      • Himeji-City, Japan
        • Site Reference ID/Investigator# 57483
      • Hokkaido, Japan
        • Site Reference ID/Investigator# 57487
      • Hyogo, Japan
        • Site Reference ID/Investigator# 53484
      • Ibaraki, Japan
        • Site Reference ID/Investigator# 54385
      • Kagawa, Japan
        • Site Reference ID/Investigator# 51581
      • Kagoshima, Japan
        • Site Reference ID/Investigator# 59164
      • Kanagawa, Japan
        • Site Reference ID/Investigator# 51574
      • Kanagawa, Japan
        • Site Reference ID/Investigator# 51575
      • Kodaira, Japan
        • Site Reference ID/Investigator# 52751
      • Koga, Japan
        • Site Reference ID/Investigator# 62025
      • Matsumoto, Japan
        • Site Reference ID/Investigator# 54384
      • Midori, Japan
        • Site Reference ID/Investigator# 52745
      • Mito, Japan
        • Site Reference ID/Investigator# 51569
      • Nagano, Japan
        • Site Reference ID/Investigator# 52964
      • Nagano, Japan
        • Site Reference ID/Investigator# 53483
      • Nagasaki, Japan
        • Site Reference ID/Investigator# 51582
      • Nagoya, Japan
        • Site Reference ID/Investigator# 54388
      • Niigata, Japan
        • Site Reference ID/Investigator# 51576
      • Niigata, Japan
        • Site Reference ID/Investigator# 51577
      • Osaka, Japan
        • Site Reference ID/Investigator# 51580
      • Osaka, Japan
        • Site Reference ID/Investigator# 52747
      • Osaka, Japan
        • Site Reference ID/Investigator# 52748
      • Osaka, Japan
        • Site Reference ID/Investigator# 52750
      • Saitama, Japan
        • Site Reference ID/Investigator# 51570
      • Sakai, Japan
        • Site Reference ID/Investigator# 54387
      • Sapporo, Japan
        • Site Reference ID/Investigator# 52746
      • Shizuoka, Japan
        • Site Reference ID/Investigator# 51579
      • Takasaki, Japan
        • Site Reference ID/Investigator# 62024
      • Tokyo, Japan
        • Site Reference ID/Investigator# 51572
      • Tokyo, Japan
        • Site Reference ID/Investigator# 52752
      • Tokyo, Japan
        • Site Reference ID/Investigator# 53482
      • Tokyo, Japan
        • Site Reference ID/Investigator# 59162
      • Tokyo, Japan
        • Site Reference ID/Investigator# 59966
      • Tomakomai-shi, Japan
        • Site Reference ID/Investigator# 53783
      • Toyama, Japan
        • Site Reference ID/Investigator# 54383
      • Wakayama, Japan
        • Site Reference ID/Investigator# 52749
      • Yachiyoshi, Japan
        • Site Reference ID/Investigator# 52962
      • Yokohama-Shi, Japan
        • Site Reference ID/Investigator# 59163

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: paricalcitol
Andere namen:
  • Zemplar
  • ABT-358
Geneesmiddel: maxacalcitol placebo
Actieve vergelijker: 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.
Geneesmiddel: maxacalcitol
Andere namen:
  • oxarol
Geneesmiddel: paricalcitol placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia
Tijdsspanne: iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).
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.
iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia
Tijdsspanne: Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).
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.
Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).
Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)
Tijdsspanne: The last three weeks of treatment (Weeks 11, 12, and 13)
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.
The last three weeks of treatment (Weeks 11, 12, and 13)
Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
Tijdsspanne: Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)
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.
Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)
Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
Tijdsspanne: Weeks 2 to 13
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.
Weeks 2 to 13
Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL
Tijdsspanne: Weeks 2 to 13
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.
Weeks 2 to 13

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AbbVie (prior sponsor, Abbott)

Onderzoekers

  • Studie directeur: Kazuya Kobayashi, BA, AbbVie GK.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2011

Primaire voltooiing (Werkelijk)

1 april 2012

Studie voltooiing (Werkelijk)

1 april 2012

Studieregistratiedata

Eerst ingediend

25 april 2011

Eerst ingediend dat voldeed aan de QC-criteria

25 april 2011

Eerst geplaatst (Schatting)

26 april 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

6 juni 2013

Laatste update ingediend die voldeed aan QC-criteria

17 april 2013

Laatst geverifieerd

1 april 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • M11-517

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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