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Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice

NCT ID: NCT01083849

Last Updated: 2014-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

761 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

Detailed Description

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According to protocol amendment of 16 October 2010 Austria is participating in this study.

Paricalcitol injection (intravenous (IV) therapy) was approved in Germany in December 2004 and in Austria in June 2003 for the prevention and treatment of secondary hyperparathyroidism in participants needing dialysis. In April 2008 in Germany and in January 2008 in Austria, paricalcitol capsules (for oral use (p.o.)) were launched for the prevention and treatment of secondary hyperparathyroidism in individuals with Chronic Kidney Disease stage 3 - 5 (i.e., predialysis and dialysis), thus enabling early treatment of participants with chronic kidney disease before they reach the stage of requiring dialysis.

Postmarketing observational studies with a well-planned study design, defined study protocol and biometrical estimates are necessary for a more profound understanding of the effectiveness and adverse drug reactions, especially those that are unknown or rare.

Accordingly, the purpose of this study is to obtain data on the safety and effectiveness of paricalcitol injection and capsules in real-life clinical practice. In this study, paricalcitol will be prescribed on an on-label basis in an everyday setting. A period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

Conditions

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Kidney Insufficiency Secondary Hyperparathyroidism

Keywords

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Observational study Paricalcitol Treatment of Hyperparathyroidism Chronic kidney disease stage 3, 4 and 5 (CKD stage 3, 4 and 5) Chronic Kidney Disease Zemplar sHPT Secondary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Paricalcitol

Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients not treated with paricalcitol for at least 6 months prior to inclusion in this study

Exclusion Criteria

* The contraindications listed in the Summary of Product Characteristics for paricalcitol injection and capsules apply
* An additional exclusion criterion is a parathyroid hormone- value of \> 1000 pg/mL (which may be a sign of tertiary hyperparathyroidism) and existing treatment with paricalcitol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Decker-Burgard, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 64522

Feldkirch, , Austria

Site Status

Site Reference ID/Investigator# 53506

Graz, , Austria

Site Status

Site Reference ID/Investigator# 53524

Graz, , Austria

Site Status

Site Reference ID/Investigator# 74733

Innsbruck, , Austria

Site Status

Site Reference ID/Investigator# 64523

Rottenmann, , Austria

Site Status

Site Reference ID/Investigator# 53525

Salzburg, , Austria

Site Status

Site Reference ID/Investigator# 53526

Sankt Pölten, , Austria

Site Status

Site Reference ID/Investigator# 69662

Steyr, , Austria

Site Status

Site Reference ID/Investigator# 53508

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 53523

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 53507

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 28352

Aachen, , Germany

Site Status

Site Reference ID/Investigator# 28359

Alsfeld, , Germany

Site Status

Site Reference ID/Investigator# 28305

Arnstadt, , Germany

Site Status

Site Reference ID/Investigator# 28306

Aschersleben, , Germany

Site Status

Site Reference ID/Investigator# 28003

Augsburg, , Germany

Site Status

Site Reference ID/Investigator# 81613

Aurich, , Germany

Site Status

Site Reference ID/Investigator# 28017

Bad Bevensen, , Germany

Site Status

Site Reference ID/Investigator# 28301

Bad Nenndorf, , Germany

Site Status

Site Reference ID/Investigator# 28296

Balingen, , Germany

Site Status

Site Reference ID/Investigator# 28021

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 28024

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 28303

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 54050

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 28022

Bernburg, , Germany

Site Status

Site Reference ID/Investigator# 30862

Betzdorf, , Germany

Site Status

Site Reference ID/Investigator# 28007

Bielefeld, , Germany

Site Status

Site Reference ID/Investigator# 28304

Burg, , Germany

Site Status

Site Reference ID/Investigator# 28014

Coburg, , Germany

Site Status

Site Reference ID/Investigator# 28023

Cottbus, , Germany

Site Status

Site Reference ID/Investigator# 28134

Demmin, , Germany

Site Status

Site Reference ID/Investigator# 28037

Dresden, , Germany

Site Status

Site Reference ID/Investigator# 43903

Dresden, , Germany

Site Status

Site Reference ID/Investigator# 99777

Elmshorn, , Germany

Site Status

Site Reference ID/Investigator# 28284

Elsenfeld, , Germany

Site Status

Site Reference ID/Investigator# 124118

Emden, , Germany

Site Status

Site Reference ID/Investigator# 54054

Emsdetten, , Germany

Site Status

Site Reference ID/Investigator# 48864

Erfurt, , Germany

Site Status

Site Reference ID/Investigator# 72343

Erkelenz, , Germany

Site Status

Site Reference ID/Investigator# 28029

Eschweiler, , Germany

Site Status

Site Reference ID/Investigator# 28287

Friedrichroda, , Germany

Site Status

Site Reference ID/Investigator# 28276

Gera, , Germany

Site Status

Site Reference ID/Investigator# 28351

Halle, , Germany

Site Status

Site Reference ID/Investigator# 28280

Hamburg, , Germany

Site Status

Site Reference ID/Investigator# 48865

Hanover, , Germany

Site Status

Site Reference ID/Investigator# 28300

Heilbronn, , Germany

Site Status

Site Reference ID/Investigator# 28011

Herford, , Germany

Site Status

Site Reference ID/Investigator# 124119

Herne, , Germany

Site Status

Site Reference ID/Investigator# 28019

Herzberg, , Germany

Site Status

Site Reference ID/Investigator# 28135

Hildesheim, , Germany

Site Status

Site Reference ID/Investigator# 28286

Hoyerswerda, , Germany

Site Status

Site Reference ID/Investigator# 28353

Ilfeld, , Germany

Site Status

Site Reference ID/Investigator# 28044

Jena, , Germany

Site Status

Site Reference ID/Investigator# 48863

Kiel, , Germany

Site Status

Site Reference ID/Investigator# 28013

Lahr, , Germany

Site Status

Site Reference ID/Investigator# 28025

Loerrach, , Germany

Site Status

Site Reference ID/Investigator# 28290

Ludwigslust, , Germany

Site Status

Site Reference ID/Investigator# 10982

Magdeburg, , Germany

Site Status

Site Reference ID/Investigator# 28291

Malente, , Germany

Site Status

Site Reference ID/Investigator# 28036

Mannheim, , Germany

Site Status

Site Reference ID/Investigator# 28302

Marburg, , Germany

Site Status

Site Reference ID/Investigator# 54051

Minden, , Germany

Site Status

Site Reference ID/Investigator# 99778

Munich, , Germany

Site Status

Site Reference ID/Investigator# 28278

Müllheim, , Germany

Site Status

Site Reference ID/Investigator# 99776

Neumünster, , Germany

Site Status

Site Reference ID/Investigator# 124120

Nordhorn, , Germany

Site Status

Site Reference ID/Investigator# 28275

Nordhorn, , Germany

Site Status

Site Reference ID/Investigator# 43904

Oberstdorf, , Germany

Site Status

Site Reference ID/Investigator# 28277

Osnabrück, , Germany

Site Status

Site Reference ID/Investigator# 28297

Peine, , Germany

Site Status

Site Reference ID/Investigator# 28307

Pirmasens, , Germany

Site Status

Site Reference ID/Investigator# 28295

Potsdam, , Germany

Site Status

Site Reference ID/Investigator# 28294

Quedlinburg, , Germany

Site Status

Site Reference ID/Investigator# 48862

Rendsburg, , Germany

Site Status

Site Reference ID/Investigator# 28042

Ribnitz-Damgarten, , Germany

Site Status

Site Reference ID/Investigator# 28282

Rostock, , Germany

Site Status

Site Reference ID/Investigator# 28033

Saint Wendel, , Germany

Site Status

Site Reference ID/Investigator# 54052

Stuttgart, , Germany

Site Status

Site Reference ID/Investigator# 28005

Stuttgart, , Germany

Site Status

Site Reference ID/Investigator# 28020

Viersen, , Germany

Site Status

Site Reference ID/Investigator# 28293

Villingen-Schwenningen, , Germany

Site Status

Site Reference ID/Investigator# 28018

Völklingen, , Germany

Site Status

Site Reference ID/Investigator# 28298

Weißenfels, , Germany

Site Status

Site Reference ID/Investigator# 28292

Wetzlar, , Germany

Site Status

Site Reference ID/Investigator# 48882

Wiesbaden, , Germany

Site Status

Site Reference ID/Investigator# 28299

Wolfenbüttel, , Germany

Site Status

Site Reference ID/Investigator# 28279

Zwickau, , Germany

Site Status

Countries

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Austria Germany

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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P10-681

Identifier Type: -

Identifier Source: org_study_id