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Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients

7. november 2014 oppdatert av: AbbVie (prior sponsor, Abbott)

A Prospective, Multicenter, Six-Month Study on the Effectiveness, Safety and Impact on Health Related Quality of Life (HRQoL) and Depression Symptoms of Paricalcitol Administered to Venezuelan Patients With Chronic Kidney Disease (Stage V) Who Are on Hemodialysis

This study was designed to evaluate the effectiveness, safety, and impact on quality of life when paricalcitol (Zemplar® intravenous [IV]) is administered in Venezuelan patients on hemodialysis who are at risk of developing secondary hyperparathyroidism associated with stage V chronic kidney disease.

Studieoversikt

Status

Avsluttet

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

105

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Venezuela
- - Acarigua, Venezuela
    - Site Reference ID/Investigator# 96757
  - Barquisimeto, Venezuela
    - Site Reference ID/Investigator# 96766
  - Caracas, Venezuela
    - Site Reference ID/Investigator# 96768
  - Maracaibo, Venezuela
    - Site Reference ID/Investigator# 96760
  - Maracaibo, Venezuela
    - Site Reference ID/Investigator# 96761
  - Miranda, Venezuela
    - Site Reference ID/Investigator# 96770
  - Monagas, Venezuela
    - Site Reference ID/Investigator# 96763
  - Naguanagua, Venezuela
    - Site Reference ID/Investigator# 96765

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

This study was conducted in 8 hemodialysis units distributed in Venezuela.

Beskrivelse

Inclusion Criteria:

Male or female ≥ 18 years old with documented diagnosis of stage V chronic kidney disease, on hemodialysis at study baseline
Subjects who have been previously treated with vitamin D or its metabolites or naïve to paricalcitol
Subjects in whom the use of paricalcitol is clinically indicated and documented by applicable and routine standard of healthcare (i.e. laboratory assessments and clinical evaluations) according to the criteria of the attending physician and in accordance with the approved label of the product in Venezuela
Subjects that provide written informed consent form stating his/her authorization and willingness to participate in the study and allowing the use and discussion of his/her personal and/or health information before entering the study
Female subjects with reproductive potential must use an approved contraceptive method (intrauterine device, birth control pills or barrier device) during and for three (03) months after discontinuation of treatment

Exclusion Criteria:

Subjects with severe hyperparathyroidism (parathyroid hormone [PTH] > 3000 pg/mL)
Subjects with hypercalcemia, adjusted according to serum albumin, hyperphosphatemia, or subjects with calcium-phosphorus product (Ca x P) ≥ 70
Known hypersensitivity and/or toxicity of vitamin D, its metabolites and/or other components of Zemplar® IV (paricalcitol)
Subjects who have participated in clinical trials within 30 days before the start of the study or who are currently enrolled in a clinical trial or under treatment with any investigational product
Subjects who cannot tolerate or cannot take phosphate binders that do not contain calcium and/or aluminum
Subjects who in the opinion of the investigator, for any reason (including medical reasons) are not eligible and/or appropriate for therapy with synthetic analogs of vitamin D and/or unwilling to complete the study visits

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Paricalcitol IV Eligible participants with diagnosis of chronic kidney disease stage V undergoing hemodialysis, treated with paricalcitol IV per routine clinical practice according to prescribing information approved in Venezuela and clinical criteria.

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit Tidsramme: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)	Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 Tidsramme: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)	Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL. Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL. Elevated Ca×P was defined as as greater or equal to 56.65 mg^2/dL^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL).	Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL Tidsramme: Baseline to Week 12, Week 12 to Week 24	Participants who achieved PTH Levels < 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24).	Baseline to Week 12, Week 12 to Week 24
Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks Tidsramme: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)	Number of participants achieving PTH level reductions to < 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24).	Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 Tidsramme: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)	The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from 'no problem' to 'extreme problem') best describes their health state.	Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24 Tidsramme: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)	The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100).	Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit Tidsramme: Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)	BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.	Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AbbVie (prior sponsor, Abbott)

Etterforskere

Studiestol: Jeanine Obage, MD, Abbott

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 2013

Primær fullføring (Faktiske)

1. november 2013

Studiet fullført (Faktiske)

1. november 2013

Datoer for studieregistrering

Først innsendt

27. desember 2012

Først innsendt som oppfylte QC-kriteriene