Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
26 maart 2012 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
237
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Athens, Griekenland, 11526
- Site Reference ID/Investigator# 32055
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Athens, Griekenland, 11528
- Site Reference ID/Investigator# 32050
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Athens, Griekenland, 11528
- Site Reference ID/Investigator# 32051
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Athens, Griekenland, 17237
- Site Reference ID/Investigator# 32049
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Athens, Griekenland
- Site Reference ID/Investigator# 5283
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Chalkida, Griekenland, 34100
- Site Reference ID/Investigator# 32056
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Chania, Griekenland, 73100
- Site Reference ID/Investigator# 32057
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Drama, Griekenland, 66100
- Site Reference ID/Investigator# 32058
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Holargos, Griekenland, 15562
- Site Reference ID/Investigator# 32077
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Katerini, Griekenland, 60100
- Site Reference ID/Investigator# 32076
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Kavala, Griekenland, 65201
- Site Reference ID/Investigator# 32059
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Komotini, Griekenland, 69100
- Site Reference ID/Investigator# 32053
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Lamia, Griekenland, 35100
- Site Reference ID/Investigator# 32060
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Lefkada, Griekenland, 31100
- Site Reference ID/Investigator# 32061
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Livadia, Griekenland, 32100
- Site Reference ID/Investigator# 32062
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Pireus, Griekenland
- Site Reference ID/Investigator# 32048
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Preveza, Griekenland, 48100
- Site Reference ID/Investigator# 32054
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Ptolemaida, Griekenland, 50200
- Site Reference ID/Investigator# 32063
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Volos, Griekenland, 38222
- Site Reference ID/Investigator# 32075
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Chronic Kidney Disease
All eligible patients treated with IV Paricalcitol (Zemplar)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Konstantinos Xynos, MD, Abbott Laboratories Hellas S.A.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2006
Primaire voltooiing (Werkelijk)
1 februari 2011
Studie voltooiing (Werkelijk)
1 februari 2011
Studieregistratiedata
Eerst ingediend
27 februari 2010
Eerst ingediend dat voldeed aan de QC-criteria
4 maart 2010
Eerst geplaatst (Schatting)
5 maart 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
27 maart 2012
Laatste update ingediend die voldeed aan QC-criteria
26 maart 2012
Laatst geverifieerd
1 maart 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- P06-120
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