Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
26. März 2012 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
237
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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Athens, Griechenland, 11526
- Site Reference ID/Investigator# 32055
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Athens, Griechenland, 11528
- Site Reference ID/Investigator# 32050
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Athens, Griechenland, 11528
- Site Reference ID/Investigator# 32051
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Athens, Griechenland, 17237
- Site Reference ID/Investigator# 32049
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Athens, Griechenland
- Site Reference ID/Investigator# 5283
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Chalkida, Griechenland, 34100
- Site Reference ID/Investigator# 32056
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Chania, Griechenland, 73100
- Site Reference ID/Investigator# 32057
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Drama, Griechenland, 66100
- Site Reference ID/Investigator# 32058
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Holargos, Griechenland, 15562
- Site Reference ID/Investigator# 32077
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Katerini, Griechenland, 60100
- Site Reference ID/Investigator# 32076
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Kavala, Griechenland, 65201
- Site Reference ID/Investigator# 32059
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Komotini, Griechenland, 69100
- Site Reference ID/Investigator# 32053
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Lamia, Griechenland, 35100
- Site Reference ID/Investigator# 32060
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Lefkada, Griechenland, 31100
- Site Reference ID/Investigator# 32061
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Livadia, Griechenland, 32100
- Site Reference ID/Investigator# 32062
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Pireus, Griechenland
- Site Reference ID/Investigator# 32048
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Preveza, Griechenland, 48100
- Site Reference ID/Investigator# 32054
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Ptolemaida, Griechenland, 50200
- Site Reference ID/Investigator# 32063
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Volos, Griechenland, 38222
- Site Reference ID/Investigator# 32075
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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
Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics
Beschreibung
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.
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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Chronic Kidney Disease
All eligible patients treated with IV Paricalcitol (Zemplar)
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
Zeitfenster: Baseline to Month 24 Visit
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The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.
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Baseline to Month 24 Visit
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Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized
Zeitfenster: Baseline to Month 24 Visit
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The mean (average) number of days hospitalized per participant for those hospitalized during the study.
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Baseline to Month 24 Visit
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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)
Zeitfenster: Baseline to Month 24 Visit
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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
Zeitfenster: 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.
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Baseline to Month 24 Visit
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The Incidence of Clinically Significant Hyperphosphatemia
Zeitfenster: Baseline to Month 24 Visit
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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.
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Baseline to Month 24 Visit
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The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product
Zeitfenster: Baseline to Month 24 Visit
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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
Zeitfenster: Baseline to Month 24 Visit
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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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienstuhl: Konstantinos Xynos, MD, Abbott Laboratories Hellas S.A.
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. Dezember 2006
Primärer Abschluss (Tatsächlich)
1. Februar 2011
Studienabschluss (Tatsächlich)
1. Februar 2011
Studienanmeldedaten
Zuerst eingereicht
27. Februar 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. März 2010
Zuerst gepostet (Schätzen)
5. März 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
27. März 2012
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. März 2012
Zuletzt verifiziert
1. März 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Neubildungen
- Nierenerkrankungen
- Urologische Erkrankungen
- Erkrankungen des endokrinen Systems
- Nebenschilddrüsenerkrankungen
- Neoplastische Prozesse
- Niereninsuffizienz, chronisch
- Hyperparathyreoidismus
- Neoplasma Metastasierung
- Nierenversagen, chronisch
- Niereninsuffizienz
- Hyperparathyreoidismus, sekundär
Andere Studien-ID-Nummern
- P06-120
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