Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands
11 januari 2013 uppdaterad av: AbbVie (prior sponsor, Abbott)
Post-marketing Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Paricalcitol i.v. in the Treatment of Chronic Kidney Disease (CKD) 5 Stage Patients With (Severe) Secondary Hyperparathyroidism in Hungary
This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands.
Participants will be followed for 6 months.
Data will be collected from participants initiated on Zemplar therapy according to standard of care.
The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the proportion of participants achieving target parathyroid hormone levels, and prevalence of elevated serum calcium and phosphate levels will be evaluated.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
Prospective data collection started at initial dosing with Zemplar (paricalcitol injection) and ended up to 6 months later.
If available, retrospective data on vitamin D treatment as well as on the incidence of hypercalcaemia and hyperphosphataemia in the 6 months leading up to paricalcitol treatment were also collected.
Eight visits were planned for documentation of prospective data.
In accordance with the non-interventional character of the study, only diagnostic and monitoring procedures were applied which are part of the routine medical care of secondary hyperparathyroidism.
Studietyp
Observationell
Inskrivning (Faktisk)
60
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Budapest, Ungern, 1083
- Site Reference ID/Investigator# 46593
-
Budapest, Ungern, 1115
- Site Reference ID/Investigator# 46585
-
Debrecen, Ungern, 4012
- Site Reference ID/Investigator# 46594
-
Gyor, Ungern, 9023
- Site Reference ID/Investigator# 47722
-
Karcag, Ungern, 5301
- Site Reference ID/Investigator# 46592
-
Karcag, Ungern, 5301
- Site Reference ID/Investigator# 58644
-
Miskolc, Ungern, 3501
- Site Reference ID/Investigator# 46595
-
Nyiregyhaza, Ungern, 4400
- Site Reference ID/Investigator# 46588
-
Pecs, Ungern, 7624
- Site Reference ID/Investigator# 46597
-
Szombathely, Ungern, 9700
- Site Reference ID/Investigator# 46590
-
Veszprem, Ungern, 8200
- Site Reference ID/Investigator# 46591
-
-
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
Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary
Beskrivning
Inclusion Criteria:
Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:
- ≥ 18 years of age,
- Willing to sign the patient information and informed consent form,
Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:
- between 500-800 pg/mL with at least two abruption of conventional vitamin D therapy due to elevated serum calcium level (i.e. > 2.4 mmol/L) in the medical history, or
- higher than 800 pg/mL and parathyroidectomy is contraindicated.
- The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.
Exclusion Criteria:
Patients cannot be enrolled in the study if any of the following exclusion criteria apply:
- The patient is already treated with Zemplar (paricalcitol injection),
- Any contraindication exists as stated in the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection),
- Patients who decline to participate in the study or decline to sign the patient information/informed consent form.
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 |
|---|
|
End-stage kidney disease with secondary hyperparathyroidism
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
Tidsram: 6 months
|
Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6
Tidsram: 6 months
|
Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
|
6 months
|
|
Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance
Tidsram: 6 months prior to start of study through 6 months of treatment
|
If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
|
6 months prior to start of study through 6 months of treatment
|
|
Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance
Tidsram: 6 months prior to start of study through 6 months of treatment
|
If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
|
6 months prior to start of study through 6 months of treatment
|
|
Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism
Tidsram: 6 months prior to start of study through 6 months of treatment
|
If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
|
6 months prior to start of study through 6 months of treatment
|
|
Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy
Tidsram: 6 months prior to start of study through baseline
|
Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline.
Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
|
6 months prior to start of study through baseline
|
|
Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Tidsram: 6 months
|
Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
|
6 months
|
|
Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy
Tidsram: 6 months prior to start of study through baseline
|
Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline.
Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
|
6 months prior to start of study through baseline
|
|
Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Tidsram: 6 months
|
Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
|
6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Tamas Schnaider, AbbVie (prior sponsor, Abbott)
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 januari 2011
Primärt slutförande (Faktisk)
1 november 2011
Avslutad studie (Faktisk)
1 november 2011
Studieregistreringsdatum
Först inskickad
22 november 2010
Först inskickad som uppfyllde QC-kriterierna
7 januari 2011
Första postat (Uppskatta)
10 januari 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
18 januari 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 januari 2013
Senast verifierad
1 januari 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P12-644
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 .