Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients
7. listopadu 2014 aktualizováno: 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.
Přehled studie
Postavení
Ukončeno
Typ studie
Pozorovací
Zápis (Aktuální)
105
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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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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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
This study was conducted in 8 hemodialysis units distributed in Venezuela.
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Studijní židle: Jeanine Obage, MD, Abbott
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2013
Primární dokončení (Aktuální)
1. listopadu 2013
Dokončení studie (Aktuální)
1. listopadu 2013
Termíny zápisu do studia
První předloženo
27. prosince 2012
První předloženo, které splnilo kritéria kontroly kvality
27. prosince 2012
První zveřejněno (Odhad)
1. ledna 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
17. listopadu 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
7. listopadu 2014
Naposledy ověřeno
1. listopadu 2014
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P13-785
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Hemodialýza
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