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

Secondary Hyperparathyroidism Clinical Trial

— TOP  

Official title:

Long-Term Therapy Outcomes When Treating CKD-patients With Paricalcitol in German Clinical Practice (TOP Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083849
• Other study ID #: P10-681
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: December 11, 2014
• Start date: March 2008
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareGermany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 761
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Kidney Insufficiency
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Locations

Country	Name	City	State
Austria	Site Reference ID/Investigator# 64522	Feldkirch
Austria	Site Reference ID/Investigator# 53506	Graz
Austria	Site Reference ID/Investigator# 53524	Graz
Austria	Site Reference ID/Investigator# 74733	Innsbruck
Austria	Site Reference ID/Investigator# 64523	Rottenmann
Austria	Site Reference ID/Investigator# 53525	Salzburg
Austria	Site Reference ID/Investigator# 53526	St. Poelten
Austria	Site Reference ID/Investigator# 69662	Steyr
Austria	Site Reference ID/Investigator# 53507	Vienna
Austria	Site Reference ID/Investigator# 53508	Vienna
Austria	Site Reference ID/Investigator# 53523	Vienna
Germany	Site Reference ID/Investigator# 28352	Aachen
Germany	Site Reference ID/Investigator# 28359	Alsfeld
Germany	Site Reference ID/Investigator# 28305	Arnstadt
Germany	Site Reference ID/Investigator# 28306	Aschersleben
Germany	Site Reference ID/Investigator# 28003	Augsburg
Germany	Site Reference ID/Investigator# 81613	Aurich
Germany	Site Reference ID/Investigator# 28017	Bad Bevensen
Germany	Site Reference ID/Investigator# 28301	Bad Nenndorf
Germany	Site Reference ID/Investigator# 28296	Balingen
Germany	Site Reference ID/Investigator# 28021	Berlin
Germany	Site Reference ID/Investigator# 28024	Berlin
Germany	Site Reference ID/Investigator# 28303	Berlin
Germany	Site Reference ID/Investigator# 54050	Berlin
Germany	Site Reference ID/Investigator# 28022	Bernburg
Germany	Site Reference ID/Investigator# 30862	Betzdorf
Germany	Site Reference ID/Investigator# 28007	Bielefeld
Germany	Site Reference ID/Investigator# 28304	Burg
Germany	Site Reference ID/Investigator# 28014	Coburg
Germany	Site Reference ID/Investigator# 28023	Cottbus
Germany	Site Reference ID/Investigator# 28134	Demmin
Germany	Site Reference ID/Investigator# 28037	Dresden
Germany	Site Reference ID/Investigator# 43903	Dresden
Germany	Site Reference ID/Investigator# 99777	Elmshorn
Germany	Site Reference ID/Investigator# 28284	Elsenfeld
Germany	Site Reference ID/Investigator# 124118	Emden
Germany	Site Reference ID/Investigator# 54054	Emsdetten
Germany	Site Reference ID/Investigator# 48864	Erfurt
Germany	Site Reference ID/Investigator# 72343	Erkelenz
Germany	Site Reference ID/Investigator# 28029	Eschweiler
Germany	Site Reference ID/Investigator# 28287	Friedrichroda
Germany	Site Reference ID/Investigator# 28276	Gera
Germany	Site Reference ID/Investigator# 28351	Halle
Germany	Site Reference ID/Investigator# 28280	Hamburg
Germany	Site Reference ID/Investigator# 48865	Hanover
Germany	Site Reference ID/Investigator# 28300	Heilbronn
Germany	Site Reference ID/Investigator# 28011	Herford
Germany	Site Reference ID/Investigator# 124119	Herne
Germany	Site Reference ID/Investigator# 28019	Herzberg
Germany	Site Reference ID/Investigator# 28135	Hildesheim
Germany	Site Reference ID/Investigator# 28286	Hoyerswerda
Germany	Site Reference ID/Investigator# 28353	Ilfeld
Germany	Site Reference ID/Investigator# 28044	Jena
Germany	Site Reference ID/Investigator# 48863	Kiel
Germany	Site Reference ID/Investigator# 28013	Lahr
Germany	Site Reference ID/Investigator# 28025	Loerrach
Germany	Site Reference ID/Investigator# 28290	Ludwigslust
Germany	Site Reference ID/Investigator# 10982	Magdeburg
Germany	Site Reference ID/Investigator# 28291	Malente
Germany	Site Reference ID/Investigator# 28036	Mannheim
Germany	Site Reference ID/Investigator# 28302	Marburg
Germany	Site Reference ID/Investigator# 54051	Minden
Germany	Site Reference ID/Investigator# 28278	Muellheim
Germany	Site Reference ID/Investigator# 99778	Munich
Germany	Site Reference ID/Investigator# 99776	Neumuenster
Germany	Site Reference ID/Investigator# 124120	Nordhorn
Germany	Site Reference ID/Investigator# 28275	Nordhorn
Germany	Site Reference ID/Investigator# 43904	Oberstdorf
Germany	Site Reference ID/Investigator# 28277	Osnabrueck
Germany	Site Reference ID/Investigator# 28297	Peine
Germany	Site Reference ID/Investigator# 28307	Pirmasens
Germany	Site Reference ID/Investigator# 28295	Potsdam
Germany	Site Reference ID/Investigator# 28294	Quedlinburg
Germany	Site Reference ID/Investigator# 48862	Rendsburg
Germany	Site Reference ID/Investigator# 28042	Ribnitz-Damgarten
Germany	Site Reference ID/Investigator# 28282	Rostock
Germany	Site Reference ID/Investigator# 28033	St. Wendel
Germany	Site Reference ID/Investigator# 28005	Stuttgart
Germany	Site Reference ID/Investigator# 54052	Stuttgart
Germany	Site Reference ID/Investigator# 28020	Viersen
Germany	Site Reference ID/Investigator# 28293	Villingen-Schwenningen
Germany	Site Reference ID/Investigator# 28018	Voelklingen
Germany	Site Reference ID/Investigator# 28298	Weissenfels
Germany	Site Reference ID/Investigator# 28292	Wetzlar
Germany	Site Reference ID/Investigator# 48882	Wiesbaden
Germany	Site Reference ID/Investigator# 28299	Wolfenbuettel
Germany	Site Reference ID/Investigator# 28279	Zwickau

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months	Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).	Up to 12 Months	Yes
Primary	Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months	Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).	Up to 12 months	No
Secondary	Number of Participants With Hypercalcemia	Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.	Months 0, 3, 6, 9, and 12	No
Secondary	Number of Participants With Hyperphosphatemia	Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.	Months 0, 3, 6, 9, and 12	No
Secondary	Number of Participants With Elevated Calcium-Phosphorus Product	Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg^2/dL^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.	Months 0, 3, 6, 9, and 12	No
Secondary	Mean Duration of Hospitalization by Visit		Months 0, 3, 6, 9, and 11	No
Secondary	Mean Duration of Disability by Visit		Months 0, 3, 6, 9, and 11	No
Secondary	Mean Intact Parathormone (iPTH) Levels by Visit		Months 0, 3, 6, 9, and 12	No
Secondary	Mean Calcium-Phosphate Product Levels by Visit		Months 0, 3, 6, 9, and 12	No

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