Study to Evaluate the Effect of Intravenous (IV) Paricalcitol (Zemplar) on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years
9. juni 2014 opdateret af: AbbVie (prior sponsor, Abbott)
Postmarketing Observational Study to Evaluate the Effect of Zemplar (Paricalcitol IV) on Cardiac Morbidity in Patients With Chronic Kidney Disease Stage 5 Over 2 Years.
The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines (150 - 300 pg/mL) after 2 years.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
Secondary hyperparathyroidism (SHPT) is a frequent complication in patients with chronic kidney disease (CKD) stage 5 receiving dialysis.
SHPT is an adaptive response to CKD and is characterized by an elevation in parathyroid hormone (PTH) and consecutively high calcium levels.
Elevations in calcium levels, phosphate levels, and PTH are correlated with CKD disease progression as well as development or aggravation of cardiovascular impairment.
Many CKD patients cannot be treated well with Vitamin D analogues because of effects on calcium.
Hypercalcemia is a well - known factor for cardiac disease.
No data are available in Austria for a cohort with cardiac disease treated with Zemplar (paricalcitol IV).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
67
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Graz, Østrig, 8010
- Site Reference ID/Investigator# 27447
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Graz, Østrig, 8020
- Site Reference ID/Investigator# 49182
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Graz, Østrig, 80360
- Site Reference ID/Investigator# 27483
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Graz, Østrig, 8052
- Site Reference ID/Investigator# 52742
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Innsbruck, Østrig, 6020
- Site Reference ID/Investigator# 27487
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Linz, Østrig, 4010
- Site Reference ID/Investigator# 36983
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Linz, Østrig, 4020
- Site Reference ID/Investigator# 27484
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Rottenmann, Østrig, 8786
- Site Reference ID/Investigator# 27485
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Vienna, Østrig, 1030
- Site Reference ID/Investigator# 27446
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Vienna, Østrig, 1090
- Site Reference ID/Investigator# 53469
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Vienna, Østrig, 1130
- Site Reference ID/Investigator# 27482
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Vienna, Østrig, 1220
- Site Reference ID/Investigator# 10981
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Investigational sites were clinic centers with experience in the treatment of chronic kidney disease stage 5 patients and hemodialysis.
Beskrivelse
Inclusion Criteria:
- Patients aged at least 18 years
- Patients with secondary hyperparathyroidism associated with CKD stage 5, serum iPTH > 150 pg/mL,
Cardiac disease as described by Medical Dictionary for Regulatory Activities (MedDRA) terms:
- cardiac disorder as cardiac arrhythmias
- cardiac disorder signs and symptoms
- cardiac neoplasm
- cardiac valve disorder
- heart failures
- myocardial disorder
- pericardial disorder
- Serum phosphate level < 6.5 mg/dL and serum calcium level < 10.5 mg/dL
Exclusion Criteria:
- Patients who meet contraindications as outlined in the latest version of Zemplar (Paricalcitol IV) summary of product characteristics
- Patients with known hypersensitivity to paricalcitol or any component of the formulation, vitamin D intoxication, hypercalcemia; cinacalcet as concomitant medication.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Paricalcitol IV
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
Tidsramme: Baseline and Months 3, 6, 12, 18, and 24
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Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL).
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Baseline and Months 3, 6, 12, 18, and 24
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With Hypercalcemia
Tidsramme: Baseline and Months 3, 6, 12, 18, and 24
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Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement.
Serum calcium was measured at every study visit.
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Baseline and Months 3, 6, 12, 18, and 24
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Percentage of Participants With Hyperphosphatemia
Tidsramme: Baseline and Months 3, 6, 12, 18, and 24
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Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement.
Serum phosphate was measured at every study visit.
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Baseline and Months 3, 6, 12, 18, and 24
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Percentage of Participants With at Least a 30%-Reduction in iPTH Levels
Tidsramme: Baseline and Months 3, 6, 12, 18, and 24
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The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.
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Baseline and Months 3, 6, 12, 18, and 24
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Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements
Tidsramme: Baseline to Month 24
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The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.
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Baseline to Month 24
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Percentage of Participants With at Least One Concomitant Medication
Tidsramme: 24 months
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The percentage of participants with at least one concomitant medication during the course of the study, by the following types:
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24 months
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Percentage of Participants Experiencing Hospitalization
Tidsramme: 24 months
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The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study.
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24 months
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Number of Participants With Cardiac Disease Progression
Tidsramme: Month 3, 6, 12, 18, and 24
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Cardiac disease progression was determined by the Investigator.
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Month 3, 6, 12, 18, and 24
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Astrid Dworan-Timler, AbbVie Austria
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2008
Primær færdiggørelse (Faktiske)
1. juni 2013
Studieafslutning (Faktiske)
1. juni 2013
Datoer for studieregistrering
Først indsendt
20. februar 2010
Først indsendt, der opfyldte QC-kriterier
22. februar 2010
Først opslået (Skøn)
23. februar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juni 2014
Sidst verificeret
1. juni 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P10-680
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