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. januar 2013 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
60
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Budapest, Ungarn, 1083
- Site Reference ID/Investigator# 46593
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Budapest, Ungarn, 1115
- Site Reference ID/Investigator# 46585
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Debrecen, Ungarn, 4012
- Site Reference ID/Investigator# 46594
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Gyor, Ungarn, 9023
- Site Reference ID/Investigator# 47722
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Karcag, Ungarn, 5301
- Site Reference ID/Investigator# 46592
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Karcag, Ungarn, 5301
- Site Reference ID/Investigator# 58644
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Miskolc, Ungarn, 3501
- Site Reference ID/Investigator# 46595
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Nyiregyhaza, Ungarn, 4400
- Site Reference ID/Investigator# 46588
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Pecs, Ungarn, 7624
- Site Reference ID/Investigator# 46597
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Szombathely, Ungarn, 9700
- Site Reference ID/Investigator# 46590
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Veszprem, Ungarn, 8200
- Site Reference ID/Investigator# 46591
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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End-stage kidney disease with secondary hyperparathyroidism
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
Tidsramme: 6 months
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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.
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6
Tidsramme: 6 months
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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.
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6 months
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Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance
Tidsramme: 6 months prior to start of study through 6 months of treatment
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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.
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6 months prior to start of study through 6 months of treatment
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Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance
Tidsramme: 6 months prior to start of study through 6 months of treatment
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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.
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6 months prior to start of study through 6 months of treatment
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Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism
Tidsramme: 6 months prior to start of study through 6 months of treatment
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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.
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6 months prior to start of study through 6 months of treatment
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Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy
Tidsramme: 6 months prior to start of study through baseline
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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).
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6 months prior to start of study through baseline
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Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Tidsramme: 6 months
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Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
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6 months
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Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy
Tidsramme: 6 months prior to start of study through baseline
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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).
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6 months prior to start of study through baseline
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Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Tidsramme: 6 months
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Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
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6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Tamas Schnaider, AbbVie (prior sponsor, Abbott)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2011
Primær fullføring (Faktiske)
1. november 2011
Studiet fullført (Faktiske)
1. november 2011
Datoer for studieregistrering
Først innsendt
22. november 2010
Først innsendt som oppfylte QC-kriteriene
7. januar 2011
Først lagt ut (Anslag)
10. januar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. januar 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. januar 2013
Sist bekreftet
1. januar 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P12-644
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