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

AbbVie (prior sponsor, Abbott)761 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

761

Conditions

Kidney Insufficiency

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (87)

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

Outcomes

Primary Outcomes

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).

Time frame: Up to 12 Months

Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months

Time frame: Up to 12 months

Secondary Outcomes

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.