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Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

26 mars 2012 mis à jour par: Abbott

A Two-year, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Haemodialysis, Receiving Zemplar for Prevention and Treatment of Secondary Hyperparathyroidism

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

The primary objective of this study is to evaluate the safety of Zemplar® in the treatment of Secondary hyperparathyroidism (iParathormone>300 pg/mL) in subjects on hemodialysis treated in conditions of usual clinical care.

The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.

A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:

40% reduction in the base iPTH level is achieved, and/or;
serum iParathormone level < 300 pg/mL.

Additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (Ca) > 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (P)>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P>65 mg^2/dL^2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.

Type d'étude

Observationnel

Inscription (Réel)

237

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

Grèce
- - Athens, Grèce, 11526
    - Site Reference ID/Investigator# 32055
  - Athens, Grèce, 11528
    - Site Reference ID/Investigator# 32050
  - Athens, Grèce, 11528
    - Site Reference ID/Investigator# 32051
  - Athens, Grèce, 17237
    - Site Reference ID/Investigator# 32049
  - Athens, Grèce
    - Site Reference ID/Investigator# 5283
  - Chalkida, Grèce, 34100
    - Site Reference ID/Investigator# 32056
  - Chania, Grèce, 73100
    - Site Reference ID/Investigator# 32057
  - Drama, Grèce, 66100
    - Site Reference ID/Investigator# 32058
  - Holargos, Grèce, 15562
    - Site Reference ID/Investigator# 32077
  - Katerini, Grèce, 60100
    - Site Reference ID/Investigator# 32076
  - Kavala, Grèce, 65201
    - Site Reference ID/Investigator# 32059
  - Komotini, Grèce, 69100
    - Site Reference ID/Investigator# 32053
  - Lamia, Grèce, 35100
    - Site Reference ID/Investigator# 32060
  - Lefkada, Grèce, 31100
    - Site Reference ID/Investigator# 32061
  - Livadia, Grèce, 32100
    - Site Reference ID/Investigator# 32062
  - Pireus, Grèce
    - Site Reference ID/Investigator# 32048
  - Preveza, Grèce, 48100
    - Site Reference ID/Investigator# 32054
  - Ptolemaida, Grèce, 50200
    - Site Reference ID/Investigator# 32063
  - Volos, Grèce, 38222
    - Site Reference ID/Investigator# 32075

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics

La description

Inclusion Criteria:

Subject is >= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone > 300 pg/mL.
Subject is receiving chronic hemodialysis.
Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
Subject has provided their informed consent to participate.

Exclusion Criteria:

Subject has a corrected serum calcium > 10.5 mg/dL, serum phosphorus >= 6.5 mg/dL or subjects with corrected Ca x P >= 65 mg^2/dl^2.
Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
Subject has participated in clinical study within the last month.
Zemplar is contraindicated according to the Summary of Product Characteristics.

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

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Chronic Kidney Disease All eligible patients treated with IV Paricalcitol (Zemplar)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations Délai: Baseline to Month 24 Visit	The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.	Baseline to Month 24 Visit
Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized Délai: Baseline to Month 24 Visit	The mean (average) number of days hospitalized per participant for those hospitalized during the study.	Baseline to Month 24 Visit

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml) Délai: Baseline to Month 24 Visit	Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.	Baseline to Month 24 Visit
The Incidence of Clinically Significant Hypercalcemia Délai: Baseline to Month 24 Visit	The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.	Baseline to Month 24 Visit
The Incidence of Clinically Significant Hyperphosphatemia Délai: Baseline to Month 24 Visit	The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.	Baseline to Month 24 Visit
The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product Délai: Baseline to Month 24 Visit	The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.	Baseline to Month 24 Visit
To Estimate the Incidence of (S)AEs/(S)ADRs Délai: Baseline to Month 24 Visit	The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.	Baseline to Month 24 Visit

Collaborateurs et enquêteurs

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

Parrainer

Abbott

Les enquêteurs

Chaise d'étude: Konstantinos Xynos, MD, Abbott Laboratories Hellas S.A.

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 décembre 2006

Achèvement primaire (Réel)

1 février 2011

Achèvement de l'étude (Réel)

1 février 2011

Dates d'inscription aux études

Première soumission

27 février 2010

Première soumission répondant aux critères de contrôle qualité

4 mars 2010

Première publication (Estimation)

5 mars 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

27 mars 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 mars 2012

Dernière vérification

1 mars 2012

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

P06-120

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 .