Clinical trial NCT01083849: Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice
Official title: Long-Term Therapy Outcomes When Treating CKD-patients With Paricalcitol in German Clinical Practice (TOP Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Insufficiency
Secondary Hyperparathyroidism
Keywords: 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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 761
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participating sites were facilities specialized in the treatment of chronic kidney disease and offices of community-based specialists/nephrologists in Germany and Austria.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria are based on the Summary of Product Characteristics for paricalcitol injection and capsules: Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease
* 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

Primary outcomes:
measure: Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
timeFrame: Up to 12 Months
measure: Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number of Participants With Hypercalcemia
timeFrame: Months 0, 3, 6, 9, and 12
measure: Number of Participants With Hyperphosphatemia
timeFrame: Months 0, 3, 6, 9, and 12
measure: Number of Participants With Elevated Calcium-Phosphorus Product
timeFrame: Months 0, 3, 6, 9, and 12
measure: Mean Duration of Hospitalization by Visit
timeFrame: Months 0, 3, 6, 9, and 11
measure: Mean Duration of Disability by Visit
timeFrame: Months 0, 3, 6, 9, and 11
measure: Mean Intact Parathormone (iPTH) Levels by Visit
timeFrame: Months 0, 3, 6, 9, and 12
measure: Mean Calcium-Phosphate Product Levels by Visit
timeFrame: Months 0, 3, 6, 9, and 12
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Site Reference ID/Investigator# 64522
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 53506
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 53524
city: Innsbruck
country: Austria
facility: Site Reference ID/Investigator# 74733
city: Rottenmann
country: Austria
facility: Site Reference ID/Investigator# 64523
city: Salzburg
country: Austria
facility: Site Reference ID/Investigator# 53525
city: St. Poelten
country: Austria
facility: Site Reference ID/Investigator# 53526
city: Steyr
country: Austria
facility: Site Reference ID/Investigator# 69662
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 53508
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 53523
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 53507
city: Aachen
country: Germany
facility: Site Reference ID/Investigator# 28352
city: Alsfeld
country: Germany
facility: Site Reference ID/Investigator# 28359
city: Arnstadt
country: Germany
facility: Site Reference ID/Investigator# 28305
city: Aschersleben
country: Germany
facility: Site Reference ID/Investigator# 28306
city: Augsburg
country: Germany
facility: Site Reference ID/Investigator# 28003
city: Aurich
country: Germany
facility: Site Reference ID/Investigator# 81613
city: Bad Bevensen
country: Germany
facility: Site Reference ID/Investigator# 28017
city: Bad Nenndorf
country: Germany
facility: Site Reference ID/Investigator# 28301
city: Balingen
country: Germany
facility: Site Reference ID/Investigator# 28296
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 28021
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 28024
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 28303
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 54050
city: Bernburg
country: Germany
facility: Site Reference ID/Investigator# 28022
city: Betzdorf
country: Germany
facility: Site Reference ID/Investigator# 30862
city: Bielefeld
country: Germany
facility: Site Reference ID/Investigator# 28007
city: Burg
country: Germany
facility: Site Reference ID/Investigator# 28304
city: Coburg
country: Germany
facility: Site Reference ID/Investigator# 28014
city: Cottbus
country: Germany
facility: Site Reference ID/Investigator# 28023
city: Demmin
country: Germany
facility: Site Reference ID/Investigator# 28134
city: Dresden
country: Germany
facility: Site Reference ID/Investigator# 28037
city: Dresden
country: Germany
facility: Site Reference ID/Investigator# 43903
city: Elmshorn
country: Germany
facility: Site Reference ID/Investigator# 99777
city: Elsenfeld
country: Germany
facility: Site Reference ID/Investigator# 28284
city: Emden
country: Germany
facility: Site Reference ID/Investigator# 124118
city: Emsdetten
country: Germany
facility: Site Reference ID/Investigator# 54054
city: Erfurt
country: Germany
facility: Site Reference ID/Investigator# 48864
city: Erkelenz
country: Germany
facility: Site Reference ID/Investigator# 72343
city: Eschweiler
country: Germany
facility: Site Reference ID/Investigator# 28029
city: Friedrichroda
country: Germany
facility: Site Reference ID/Investigator# 28287
city: Gera
country: Germany
facility: Site Reference ID/Investigator# 28276
city: Halle
country: Germany
facility: Site Reference ID/Investigator# 28351
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 28280
city: Hanover
country: Germany
facility: Site Reference ID/Investigator# 48865
city: Heilbronn
country: Germany
facility: Site Reference ID/Investigator# 28300
city: Herford
country: Germany
facility: Site Reference ID/Investigator# 28011
city: Herne
country: Germany
facility: Site Reference ID/Investigator# 124119
city: Herzberg
country: Germany
facility: Site Reference ID/Investigator# 28019
city: Hildesheim
country: Germany
facility: Site Reference ID/Investigator# 28135
city: Hoyerswerda
country: Germany
facility: Site Reference ID/Investigator# 28286
city: Ilfeld
country: Germany
facility: Site Reference ID/Investigator# 28353
city: Jena
country: Germany
facility: Site Reference ID/Investigator# 28044
city: Kiel
country: Germany
facility: Site Reference ID/Investigator# 48863
city: Lahr
country: Germany
facility: Site Reference ID/Investigator# 28013
city: Loerrach
country: Germany
facility: Site Reference ID/Investigator# 28025
city: Ludwigslust
country: Germany
facility: Site Reference ID/Investigator# 28290
city: Magdeburg
country: Germany
facility: Site Reference ID/Investigator# 10982
city: Malente
country: Germany
facility: Site Reference ID/Investigator# 28291
city: Mannheim
country: Germany
facility: Site Reference ID/Investigator# 28036
city: Marburg
country: Germany
facility: Site Reference ID/Investigator# 28302
city: Minden
country: Germany
facility: Site Reference ID/Investigator# 54051
city: Muellheim
country: Germany
facility: Site Reference ID/Investigator# 28278
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 99778
city: Neumuenster
country: Germany
facility: Site Reference ID/Investigator# 99776
city: Nordhorn
country: Germany
facility: Site Reference ID/Investigator# 124120
city: Nordhorn
country: Germany
facility: Site Reference ID/Investigator# 28275
city: Oberstdorf
country: Germany
facility: Site Reference ID/Investigator# 43904
city: Osnabrueck
country: Germany
facility: Site Reference ID/Investigator# 28277
city: Peine
country: Germany
facility: Site Reference ID/Investigator# 28297
city: Pirmasens
country: Germany
facility: Site Reference ID/Investigator# 28307
city: Potsdam
country: Germany
facility: Site Reference ID/Investigator# 28295
city: Quedlinburg
country: Germany
facility: Site Reference ID/Investigator# 28294
city: Rendsburg
country: Germany
facility: Site Reference ID/Investigator# 48862
city: Ribnitz-Damgarten
country: Germany
facility: Site Reference ID/Investigator# 28042
city: Rostock
country: Germany
facility: Site Reference ID/Investigator# 28282
city: St. Wendel
country: Germany
facility: Site Reference ID/Investigator# 28033
city: Stuttgart
country: Germany
facility: Site Reference ID/Investigator# 54052
city: Stuttgart
country: Germany
facility: Site Reference ID/Investigator# 28005
city: Viersen
country: Germany
facility: Site Reference ID/Investigator# 28020
city: Villingen-Schwenningen
country: Germany
facility: Site Reference ID/Investigator# 28293
city: Voelklingen
country: Germany
facility: Site Reference ID/Investigator# 28018
city: Weissenfels
country: Germany
facility: Site Reference ID/Investigator# 28298
city: Wetzlar
country: Germany
facility: Site Reference ID/Investigator# 28292
city: Wiesbaden
country: Germany
facility: Site Reference ID/Investigator# 48882
city: Wolfenbuettel
country: Germany
facility: Site Reference ID/Investigator# 28299
city: Zwickau
country: Germany
facility: Site Reference ID/Investigator# 28279
Study officials:
affiliation: AbbVie
name: Sabine Decker-Burgard, MD
role: STUDY_DIRECTOR
References: