Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients
7. November 2014 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
105
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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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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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
This study was conducted in 8 hemodialysis units distributed in Venezuela.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienstuhl: Jeanine Obage, MD, Abbott
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2013
Primärer Abschluss (Tatsächlich)
1. November 2013
Studienabschluss (Tatsächlich)
1. November 2013
Studienanmeldedaten
Zuerst eingereicht
27. Dezember 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. Dezember 2012
Zuerst gepostet (Schätzen)
1. Januar 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
17. November 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
7. November 2014
Zuletzt verifiziert
1. November 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P13-785
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