Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients
7 novembre 2014 aggiornato da: AbbVie (prior sponsor, Abbott)
A Prospective, Multicenter, Six-Month Study on the Effectiveness, Safety and Impact on Health Related Quality of Life (HRQoL) and Depression Symptoms of Paricalcitol Administered to Venezuelan Patients With Chronic Kidney Disease (Stage V) Who Are on Hemodialysis
This study was designed to evaluate the effectiveness, safety, and impact on quality of life when paricalcitol (Zemplar® intravenous [IV]) is administered in Venezuelan patients on hemodialysis who are at risk of developing secondary hyperparathyroidism associated with stage V chronic kidney disease.
Panoramica dello studio
Stato
Terminato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
105
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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Acarigua, Venezuela
- Site Reference ID/Investigator# 96757
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Barquisimeto, Venezuela
- Site Reference ID/Investigator# 96766
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Caracas, Venezuela
- Site Reference ID/Investigator# 96768
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Maracaibo, Venezuela
- Site Reference ID/Investigator# 96760
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Maracaibo, Venezuela
- Site Reference ID/Investigator# 96761
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Miranda, Venezuela
- Site Reference ID/Investigator# 96770
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Monagas, Venezuela
- Site Reference ID/Investigator# 96763
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Naguanagua, Venezuela
- Site Reference ID/Investigator# 96765
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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
This study was conducted in 8 hemodialysis units distributed in Venezuela.
Descrizione
Inclusion Criteria:
- Male or female ≥ 18 years old with documented diagnosis of stage V chronic kidney disease, on hemodialysis at study baseline
- Subjects who have been previously treated with vitamin D or its metabolites or naïve to paricalcitol
- Subjects in whom the use of paricalcitol is clinically indicated and documented by applicable and routine standard of healthcare (i.e. laboratory assessments and clinical evaluations) according to the criteria of the attending physician and in accordance with the approved label of the product in Venezuela
- Subjects that provide written informed consent form stating his/her authorization and willingness to participate in the study and allowing the use and discussion of his/her personal and/or health information before entering the study
- Female subjects with reproductive potential must use an approved contraceptive method (intrauterine device, birth control pills or barrier device) during and for three (03) months after discontinuation of treatment
Exclusion Criteria:
- Subjects with severe hyperparathyroidism (parathyroid hormone [PTH] > 3000 pg/mL)
- Subjects with hypercalcemia, adjusted according to serum albumin, hyperphosphatemia, or subjects with calcium-phosphorus product (Ca x P) ≥ 70
- Known hypersensitivity and/or toxicity of vitamin D, its metabolites and/or other components of Zemplar® IV (paricalcitol)
- Subjects who have participated in clinical trials within 30 days before the start of the study or who are currently enrolled in a clinical trial or under treatment with any investigational product
- Subjects who cannot tolerate or cannot take phosphate binders that do not contain calcium and/or aluminum
- Subjects who in the opinion of the investigator, for any reason (including medical reasons) are not eligible and/or appropriate for therapy with synthetic analogs of vitamin D and/or unwilling to complete the study visits
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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Paricalcitol IV
Eligible participants with diagnosis of chronic kidney disease stage V undergoing hemodialysis, treated with paricalcitol IV per routine clinical practice according to prescribing information approved in Venezuela and clinical criteria.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit
Lasso di tempo: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
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Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24
Lasso di tempo: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
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Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL. Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL. Elevated Ca×P was defined as as greater or equal to 56.65 mg^2/dL^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL). |
Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
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Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL
Lasso di tempo: Baseline to Week 12, Week 12 to Week 24
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Participants who achieved PTH Levels < 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24).
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Baseline to Week 12, Week 12 to Week 24
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Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks
Lasso di tempo: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
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Number of participants achieving PTH level reductions to < 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24).
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Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
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European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24
Lasso di tempo: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
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The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS).
For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from 'no problem' to 'extreme problem') best describes their health state.
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Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
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European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24
Lasso di tempo: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
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The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS.
For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100).
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Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
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Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit
Lasso di tempo: Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)
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BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression.
The range of scores is 0 to 63, with a higher value representing a worse outcome.
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Baseline Week 1 (Study Visit 1), Week 24 (Final Study 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: Jeanine Obage, MD, Abbott
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 gennaio 2013
Completamento primario (Effettivo)
1 novembre 2013
Completamento dello studio (Effettivo)
1 novembre 2013
Date di iscrizione allo studio
Primo inviato
27 dicembre 2012
Primo inviato che soddisfa i criteri di controllo qualità
27 dicembre 2012
Primo Inserito (Stima)
1 gennaio 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
17 novembre 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 novembre 2014
Ultimo verificato
1 novembre 2014
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P13-785
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 .