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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 avril 2013 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

255

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: paricalcitol
Autres noms:
  • Zemplar
  • ABT-358
Médicament: maxacalcitol placebo
Comparateur actif: 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.
Médicament: maxacalcitol
Autres noms:
  • oxarol
Médicament: paricalcitol placebo

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AbbVie (prior sponsor, Abbott)

Les enquêteurs

  • Directeur d'études: Kazuya Kobayashi, BA, AbbVie GK.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2011

Achèvement primaire (Réel)

1 avril 2012

Achèvement de l'étude (Réel)

1 avril 2012

Dates d'inscription aux études

Première soumission

25 avril 2011

Première soumission répondant aux critères de contrôle qualité

25 avril 2011

Première publication (Estimation)

26 avril 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

6 juin 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 avril 2013

Dernière vérification

1 avril 2013

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • M11-517

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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