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

Condition(s) targeted: Kidney Insufficiency; Secondary Hyperparathyroidism

Intervention: Zemplar (paricalcitol) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Helmut Geiger, MD, Principal Investigator, Affiliation: Klinikum der J.W. Goethe Iniversität

Overall contact:
Hans-Walter Mueller, PhD, Phone: 00496122581005, Email: hans-walter.mueller@abbvie.com

The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® injection and Zemplar® capsules in real-life clinical practice. In this study, Zemplar® 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 Zemplar® injection and Zemplar® capsules in long-term use.

Official title: Long-Term Therapy Outcomes When Treating Chronic Kidney Disease Patients With Paricalcitol in German and Austrian Clinical Practice

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Chronic Kidney Disease relevant laboratory parameters

Secondary outcome:

Laboratory parameter of hypercalcemia

Laboratory parameter of hyperphosphatemia

Laboratory parameter of proteinuria

Detailed description: According to protocol amendment of 16 Oct 2010 Austria is participating in this study.

Zemplar® injection (paricalcitol i. v.) was approved in Germany in December 2004 and in Austria in June 2003 for the prevention and treatment of secondary hyperparathyroidism in patients needing dialysis. In April 2008 in Germany and in January 2008 in Austria, Zemplar® capsules (paricalcitol for oral use) 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 patients 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 Zemplar® injection and Zemplar® capsules in real-life clinical practice. In this study, Zemplar® 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 Zemplar® injection and Zemplar® capsules in long-term use.

The primary aim of the study is to determine (i) the percentage of patients achieving an iPTH level within the target range of K/DQOI treatment guidelines (Chronic Kidney Disease 3:

35 - 70 pg/ml; Chronic Kidney Disease 4: 70 - 110 pg/ml; Chronic Kidney Disease 5: 150 - 300

pg/ml) during 12-month treatment with Zemplar®, (ii) the time it takes to achieve this level of response and whether it is sustained.

Secondary objectives are analysis of episodes of hypercalcemia, hyperphosphatemia and calcium phosphate product, dipstick proteinuria, health economics aspects (e. g. days off sick, hospitalizations), quality of life, adverse events, eGFR, compliance and other lab markers such as alkaline phosphatase, creatinine, 25-OH vitamin D and C-reactive protein (CRP) during the first 12 months of treatment with Zemplar®.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The inclusion criteria are based on the Summary of Product Characteristics for

Zemplar® injection and Zemplar® capsules (Appendix I and II): Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease.

- Patients not treated with Zemplar® (paricalcitol) for at least 6 months prior to

inclusion in this study

- Patients 18 years of age

Exclusion Criteria:

- The contraindications listed in the Summary of Product Characteristics for Zemplar®

injection and Zemplar® capsules apply (Appendix I and II)

- 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 Zemplar® (paricalcitol)

Hans-Walter Mueller, PhD, Phone: 00496122581005, Email: hans-walter.mueller@abbvie.com

Site Reference ID/Investigator# 64522, Feldkirch 6800, Austria; Recruiting
Site Reference ID/Investigator# 64522, Principal Investigator

Site Reference ID/Investigator# 53506, Graz 8010, Austria; Recruiting
Site Reference ID/Investigator# 53506, Principal Investigator

Site Reference ID/Investigator# 74733, Innsbruck A-6020, Austria; Recruiting
Site Reference ID/Investigator# 74733, Principal Investigator

Site Reference ID/Investigator# 64523, Rottenmann 8786, Austria; Recruiting
Site Reference ID/Investigator# 64523, Principal Investigator

Site Reference ID/Investigator# 53526, St. Poelten 3100, Austria; Recruiting
Site Reference ID/Investigator# 53526, Principal Investigator

Site Reference ID/Investigator# 69662, Steyr 4400, Austria; Recruiting
Site Reference ID/Investigator# 69662, Principal Investigator

Site Reference ID/Investigator# 53508, Vienna 1090, Austria; Recruiting
Site Reference ID/Investigator# 53508, Principal Investigator

Site Reference ID/Investigator# 53523, Vienna 1130, Austria; Recruiting
Site Reference ID/Investigator# 53523, Principal Investigator

Site Reference ID/Investigator# 53507, Vienna 1220, Austria; Recruiting
Site Reference ID/Investigator# 53507, Principal Investigator

Site Reference ID/Investigator# 28352, Aachen 52066, Germany; Recruiting
Site Reference ID/Investigator# 28352, Principal Investigator

Site Reference ID/Investigator# 28359, Alsfeld 36304, Germany; Recruiting
Site Reference ID/Investigator# 28359, Principal Investigator

Site Reference ID/Investigator# 28305, Arnstadt 99310, Germany; Recruiting
Site Reference ID/Investigator# 28305, Principal Investigator

Site Reference ID/Investigator# 28306, Aschersleben 06449, Germany; Recruiting
Site Reference ID/Investigator# 28306, Principal Investigator

Site Reference ID/Investigator# 28003, Augsburg 86154, Germany; Recruiting
Site Reference ID/Investigator# 28003, Principal Investigator

Site Reference ID/Investigator# 81613, Aurich 26605, Germany; Recruiting
Site Reference ID/Investigator# 81613, Principal Investigator

Site Reference ID/Investigator# 28017, Bad Bevensen 29549, Germany; Recruiting
Site Reference ID/Investigator# 28017, Principal Investigator

Site Reference ID/Investigator# 28301, Bad Nenndorf 31542, Germany; Recruiting
Site Reference ID/Investigator# 28301, Principal Investigator

Site Reference ID/Investigator# 28296, Balingen 72336, Germany; Recruiting
Site Reference ID/Investigator# 28296, Principal Investigator

Site Reference ID/Investigator# 54050, Berlin 14193, Germany; Recruiting
Site Reference ID/Investigator# 54050, Principal Investigator

Site Reference ID/Investigator# 28021, Berlin 10785, Germany; Recruiting
Site Reference ID/Investigator# 28021, Principal Investigator

Site Reference ID/Investigator# 28303, Berlin 12627, Germany; Recruiting
Site Reference ID/Investigator# 28303, Principal Investigator

Site Reference ID/Investigator# 28022, Bernburg 06406, Germany; Recruiting
Site Reference ID/Investigator# 28022, Principal Investigator

Site Reference ID/Investigator# 30862, Betzdorf 57518, Germany; Recruiting
Site Reference ID/Investigator# 30862, Principal Investigator

Site Reference ID/Investigator# 28007, Bielefeld 33609, Germany; Recruiting
Site Reference ID/Investigator# 28007, Principal Investigator

Site Reference ID/Investigator# 28304, Burg 39288, Germany; Recruiting
Site Reference ID/Investigator# 28304, Principal Investigator

Site Reference ID/Investigator# 28014, Coburg 96450, Germany; Recruiting
Site Reference ID/Investigator# 28014, Principal Investigator

Site Reference ID/Investigator# 28023, Cottbus 03046, Germany; Recruiting
Site Reference ID/Investigator# 28023, Principal Investigator

Site Reference ID/Investigator# 28134, Demmin 17109, Germany; Recruiting
Site Reference ID/Investigator# 28134, Principal Investigator

Site Reference ID/Investigator# 43903, Dresden 01307, Germany; Recruiting
Site Reference ID/Investigator# 43903, Principal Investigator

Site Reference ID/Investigator# 28284, Elsenfeld 63820, Germany; Recruiting
Site Reference ID/Investigator# 28284, Principal Investigator

Site Reference ID/Investigator# 48864, Erfurt 99089, Germany; Recruiting
Site Reference ID/Investigator# 48864, Principal Investigator

Site Reference ID/Investigator# 72343, Erkelenz 41812, Germany; Recruiting
Site Reference ID/Investigator# 72343, Principal Investigator

Site Reference ID/Investigator# 28029, Eschweiler 52249, Germany; Recruiting
Site Reference ID/Investigator# 28029, Principal Investigator

Site Reference ID/Investigator# 28287, Friedrichroda 99894, Germany; Recruiting
Site Reference ID/Investigator# 28287, Principal Investigator

Site Reference ID/Investigator# 28276, Gera 07548, Germany; Recruiting
Site Reference ID/Investigator# 28276, Principal Investigator

Site Reference ID/Investigator# 28351, Halle 06118, Germany; Recruiting
Site Reference ID/Investigator# 28351, Principal Investigator

Site Reference ID/Investigator# 28280, Hamburg 22767, Germany; Recruiting
Site Reference ID/Investigator# 28280, Principal Investigator

Site Reference ID/Investigator# 48865, Hanover 30625, Germany; Recruiting
Site Reference ID/Investigator# 48865, Principal Investigator

Site Reference ID/Investigator# 28300, Heilbronn 74076, Germany; Recruiting
Site Reference ID/Investigator# 28300, Principal Investigator

Site Reference ID/Investigator# 28011, Herford 32049, Germany; Recruiting
Site Reference ID/Investigator# 28011, Principal Investigator

Site Reference ID/Investigator# 28019, Herzberg 04916, Germany; Recruiting
Site Reference ID/Investigator# 28019, Principal Investigator

Site Reference ID/Investigator# 28135, Hildesheim 31134, Germany; Recruiting
Site Reference ID/Investigator# 28135, Principal Investigator

Site Reference ID/Investigator# 28286, Hoyerswerda 02977, Germany; Recruiting
Site Reference ID/Investigator# 28286, Principal Investigator

Site Reference ID/Investigator# 28353, Ilfeld 99768, Germany; Recruiting
Site Reference ID/Investigator# 28353, Principal Investigator

Site Reference ID/Investigator# 28044, Jena 07743, Germany; Recruiting
Site Reference ID/Investigator# 28044, Principal Investigator

Site Reference ID/Investigator# 48863, Kiel 24106, Germany; Recruiting
Site Reference ID/Investigator# 48863, Principal Investigator

Site Reference ID/Investigator# 28013, Lahr 77933, Germany; Recruiting
Site Reference ID/Investigator# 28013, Principal Investigator

Site Reference ID/Investigator# 28025, Loerrach 79539, Germany; Recruiting
Site Reference ID/Investigator# 28025, Principal Investigator

Site Reference ID/Investigator# 28290, Ludwigslust 19288, Germany; Recruiting
Site Reference ID/Investigator# 28290, Principal Investigator

Site Reference ID/Investigator# 10982, Magdeburg 39108, Germany; Recruiting
Site Reference ID/Investigator# 10982, Principal Investigator

Site Reference ID/Investigator# 28291, Malente 23714, Germany; Recruiting
Site Reference ID/Investigator# 28291, Principal Investigator

Site Reference ID/Investigator# 28036, Mannheim 68309, Germany; Recruiting
Site Reference ID/Investigator# 28036, Principal Investigator

Site Reference ID/Investigator# 28302, Marburg 35043, Germany; Recruiting
Site Reference ID/Investigator# 28302, Principal Investigator

Site Reference ID/Investigator# 28278, Muellheim 79379, Germany; Recruiting
Site Reference ID/Investigator# 28278, Principal Investigator

Site Reference ID/Investigator# 28275, Nordhorn 48529, Germany; Recruiting
Site Reference ID/Investigator# 28275, Principal Investigator

Site Reference ID/Investigator# 43904, Oberstdorf 87561, Germany; Recruiting
Site Reference ID/Investigator# 43904, Principal Investigator

Site Reference ID/Investigator# 28277, Osnabrueck 49074, Germany; Recruiting
Site Reference ID/Investigator# 28277, Principal Investigator

Site Reference ID/Investigator# 28297, Peine 31224, Germany; Recruiting
Site Reference ID/Investigator# 28297, Principal Investigator

Site Reference ID/Investigator# 28307, Pirmasens 66953, Germany; Recruiting
Site Reference ID/Investigator# 28307, Principal Investigator

Site Reference ID/Investigator# 28295, Potsdam 14482, Germany; Recruiting
Site Reference ID/Investigator# 28295, Principal Investigator

Site Reference ID/Investigator# 28294, Quedlinburg 06484, Germany; Recruiting
Site Reference ID/Investigator# 28294, Principal Investigator

Site Reference ID/Investigator# 48862, Rendsburg 24768, Germany; Recruiting
Site Reference ID/Investigator# 48862, Principal Investigator

Site Reference ID/Investigator# 28042, Ribnitz-Damgarten 18311, Germany; Recruiting
Site Reference ID/Investigator# 28042, Principal Investigator

Site Reference ID/Investigator# 28282, Rostock 18107, Germany; Recruiting
Site Reference ID/Investigator# 28282, Principal Investigator

Site Reference ID/Investigator# 28033, St. Wendel 66606, Germany; Recruiting
Site Reference ID/Investigator# 28033, Principal Investigator

Site Reference ID/Investigator# 54052, Stuttgart 70199, Germany; Recruiting
Site Reference ID/Investigator# 54052, Principal Investigator

Site Reference ID/Investigator# 28005, Stuttgart 70376, Germany; Recruiting
Site Reference ID/Investigator# 28005, Principal Investigator

Site Reference ID/Investigator# 28020, Viersen 41751, Germany; Recruiting
Site Reference ID/Investigator# 28020, Principal Investigator

Site Reference ID/Investigator# 28293, Villingen-Schwenningen 78054, Germany; Recruiting
Site Reference ID/Investigator# 28293, Principal Investigator

Site Reference ID/Investigator# 28018, Voelklingen 66333, Germany; Recruiting
Site Reference ID/Investigator# 28018, Principal Investigator

Site Reference ID/Investigator# 28298, Weissenfels 06667, Germany; Recruiting
Site Reference ID/Investigator# 28298, Principal Investigator

Site Reference ID/Investigator# 28292, Wetzlar 35578, Germany; Recruiting
Site Reference ID/Investigator# 28292, Principal Investigator

Site Reference ID/Investigator# 48882, Wiesbaden 65191, Germany; Recruiting
Site Reference ID/Investigator# 48882, Principal Investigator

Site Reference ID/Investigator# 28299, Wolfenbuettel 38304, Germany; Recruiting
Site Reference ID/Investigator# 28299, Principal Investigator

Site Reference ID/Investigator# 28279, Zwickau 08056, Germany; Recruiting
Site Reference ID/Investigator# 28279, Principal Investigator

Starting date: August 2008
Last updated: January 2, 2013