Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
26 mars 2012 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
237
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Athens, Grekland, 11526
- Site Reference ID/Investigator# 32055
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Athens, Grekland, 11528
- Site Reference ID/Investigator# 32050
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Athens, Grekland, 11528
- Site Reference ID/Investigator# 32051
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Athens, Grekland, 17237
- Site Reference ID/Investigator# 32049
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Athens, Grekland
- Site Reference ID/Investigator# 5283
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Chalkida, Grekland, 34100
- Site Reference ID/Investigator# 32056
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Chania, Grekland, 73100
- Site Reference ID/Investigator# 32057
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Drama, Grekland, 66100
- Site Reference ID/Investigator# 32058
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Holargos, Grekland, 15562
- Site Reference ID/Investigator# 32077
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Katerini, Grekland, 60100
- Site Reference ID/Investigator# 32076
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Kavala, Grekland, 65201
- Site Reference ID/Investigator# 32059
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Komotini, Grekland, 69100
- Site Reference ID/Investigator# 32053
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Lamia, Grekland, 35100
- Site Reference ID/Investigator# 32060
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Lefkada, Grekland, 31100
- Site Reference ID/Investigator# 32061
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Livadia, Grekland, 32100
- Site Reference ID/Investigator# 32062
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Pireus, Grekland
- Site Reference ID/Investigator# 32048
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Preveza, Grekland, 48100
- Site Reference ID/Investigator# 32054
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Ptolemaida, Grekland, 50200
- Site Reference ID/Investigator# 32063
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Volos, Grekland, 38222
- Site Reference ID/Investigator# 32075
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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Chronic Kidney Disease
All eligible patients treated with IV Paricalcitol (Zemplar)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
Tidsram: Baseline to Month 24 Visit
|
The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.
|
Baseline to Month 24 Visit
|
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Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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)
Tidsram: Baseline to Month 24 Visit
|
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
Tidsram: 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
Tidsram: Baseline to Month 24 Visit
|
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.
|
Baseline to Month 24 Visit
|
|
The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product
Tidsram: Baseline to Month 24 Visit
|
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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Konstantinos Xynos, MD, Abbott Laboratories Hellas S.A.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2006
Primärt slutförande (Faktisk)
1 februari 2011
Avslutad studie (Faktisk)
1 februari 2011
Studieregistreringsdatum
Först inskickad
27 februari 2010
Först inskickad som uppfyllde QC-kriterierna
4 mars 2010
Första postat (Uppskatta)
5 mars 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 mars 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 mars 2012
Senast verifierad
1 mars 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P06-120
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