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 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
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).
Studietyp
Observationell
Inskrivning (Faktisk)
67
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Graz, Österrike, 8010
- Site Reference ID/Investigator# 27447
-
Graz, Österrike, 8020
- Site Reference ID/Investigator# 49182
-
Graz, Österrike, 80360
- Site Reference ID/Investigator# 27483
-
Graz, Österrike, 8052
- Site Reference ID/Investigator# 52742
-
Innsbruck, Österrike, 6020
- Site Reference ID/Investigator# 27487
-
Linz, Österrike, 4010
- Site Reference ID/Investigator# 36983
-
Linz, Österrike, 4020
- Site Reference ID/Investigator# 27484
-
Rottenmann, Österrike, 8786
- Site Reference ID/Investigator# 27485
-
Vienna, Österrike, 1030
- Site Reference ID/Investigator# 27446
-
Vienna, Österrike, 1090
- Site Reference ID/Investigator# 53469
-
Vienna, Österrike, 1130
- Site Reference ID/Investigator# 27482
-
Vienna, Österrike, 1220
- Site Reference ID/Investigator# 10981
-
-
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
Investigational sites were clinic centers with experience in the treatment of chronic kidney disease stage 5 patients and hemodialysis.
Beskrivning
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
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 |
|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
Tidsram: Baseline and Months 3, 6, 12, 18, and 24
|
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).
|
Baseline and Months 3, 6, 12, 18, and 24
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants With Hypercalcemia
Tidsram: Baseline and Months 3, 6, 12, 18, and 24
|
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.
|
Baseline and Months 3, 6, 12, 18, and 24
|
|
Percentage of Participants With Hyperphosphatemia
Tidsram: Baseline and Months 3, 6, 12, 18, and 24
|
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.
|
Baseline and Months 3, 6, 12, 18, and 24
|
|
Percentage of Participants With at Least a 30%-Reduction in iPTH Levels
Tidsram: Baseline and Months 3, 6, 12, 18, and 24
|
The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.
|
Baseline and Months 3, 6, 12, 18, and 24
|
|
Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements
Tidsram: Baseline to Month 24
|
The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.
|
Baseline to Month 24
|
|
Percentage of Participants With at Least One Concomitant Medication
Tidsram: 24 months
|
The percentage of participants with at least one concomitant medication during the course of the study, by the following types:
|
24 months
|
|
Percentage of Participants Experiencing Hospitalization
Tidsram: 24 months
|
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.
|
24 months
|
|
Number of Participants With Cardiac Disease Progression
Tidsram: Month 3, 6, 12, 18, and 24
|
Cardiac disease progression was determined by the Investigator.
|
Month 3, 6, 12, 18, and 24
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Astrid Dworan-Timler, AbbVie Austria
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
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 2008
Primärt slutförande (Faktisk)
1 juni 2013
Avslutad studie (Faktisk)
1 juni 2013
Studieregistreringsdatum
Först inskickad
20 februari 2010
Först inskickad som uppfyllde QC-kriterierna
22 februari 2010
Första postat (Uppskatta)
23 februari 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 juli 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 juni 2014
Senast verifierad
1 juni 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P10-680
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .