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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 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

255

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • 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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Paricalcitol
Andere Namen:
  • Zemplar
  • ABT-358
Arzneimittel: maxacalcitol placebo
Aktiver 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.
Arzneimittel: maxacalcitol
Andere Namen:
  • oxarol
Arzneimittel: paricalcitol placebo

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AbbVie (prior sponsor, Abbott)

Ermittler

  • Studienleiter: Kazuya Kobayashi, BA, AbbVie GK.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Mai 2011

Primärer Abschluss (Tatsächlich)

1. April 2012

Studienabschluss (Tatsächlich)

1. April 2012

Studienanmeldedaten

Zuerst eingereicht

25. April 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. April 2011

Zuerst gepostet (Schätzen)

26. April 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

6. Juni 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. April 2013

Zuletzt verifiziert

1. April 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • M11-517

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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