Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
26 marzo 2012 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
237
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Athens, Grecia, 11526
- Site Reference ID/Investigator# 32055
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Athens, Grecia, 11528
- Site Reference ID/Investigator# 32050
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Athens, Grecia, 11528
- Site Reference ID/Investigator# 32051
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Athens, Grecia, 17237
- Site Reference ID/Investigator# 32049
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Athens, Grecia
- Site Reference ID/Investigator# 5283
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Chalkida, Grecia, 34100
- Site Reference ID/Investigator# 32056
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Chania, Grecia, 73100
- Site Reference ID/Investigator# 32057
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Drama, Grecia, 66100
- Site Reference ID/Investigator# 32058
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Holargos, Grecia, 15562
- Site Reference ID/Investigator# 32077
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Katerini, Grecia, 60100
- Site Reference ID/Investigator# 32076
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Kavala, Grecia, 65201
- Site Reference ID/Investigator# 32059
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Komotini, Grecia, 69100
- Site Reference ID/Investigator# 32053
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Lamia, Grecia, 35100
- Site Reference ID/Investigator# 32060
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Lefkada, Grecia, 31100
- Site Reference ID/Investigator# 32061
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Livadia, Grecia, 32100
- Site Reference ID/Investigator# 32062
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Pireus, Grecia
- Site Reference ID/Investigator# 32048
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Preveza, Grecia, 48100
- Site Reference ID/Investigator# 32054
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Ptolemaida, Grecia, 50200
- Site Reference ID/Investigator# 32063
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Volos, Grecia, 38222
- Site Reference ID/Investigator# 32075
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Chronic Kidney Disease
All eligible patients treated with IV Paricalcitol (Zemplar)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
Lasso di tempo: 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
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Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized
Lasso di tempo: Baseline to Month 24 Visit
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The mean (average) number of days hospitalized per participant for those hospitalized during the study.
|
Baseline to Month 24 Visit
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)
Lasso di tempo: 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.
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Baseline to Month 24 Visit
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The Incidence of Clinically Significant Hypercalcemia
Lasso di tempo: Baseline to Month 24 Visit
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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
Lasso di tempo: 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
Lasso di tempo: 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.
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Baseline to Month 24 Visit
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To Estimate the Incidence of (S)AEs/(S)ADRs
Lasso di tempo: 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.
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Baseline to Month 24 Visit
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Cattedra di studio: Konstantinos Xynos, MD, Abbott Laboratories Hellas S.A.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 dicembre 2006
Completamento primario (Effettivo)
1 febbraio 2011
Completamento dello studio (Effettivo)
1 febbraio 2011
Date di iscrizione allo studio
Primo inviato
27 febbraio 2010
Primo inviato che soddisfa i criteri di controllo qualità
4 marzo 2010
Primo Inserito (Stima)
5 marzo 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
27 marzo 2012
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 marzo 2012
Ultimo verificato
1 marzo 2012
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P06-120
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .