Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis

Abbott

Status: Completed

Conditions: Parathyroid Hormone

Treatments: Drug: Zemplar iv (paricalcitol iv)

Study type: Observational

Funder types: Industry

Identifiers

NCT01084538

P10-231

Details and patient eligibility

About

This is the post-marketing study conducted in two countries: Croatia and Serbia. In both countries Zemplar (paricalcitol) is the first injectable form of any Vitamin D Receptor (VDR) activator available for chronic kidney disease patients on hemodialysis. The evaluation of outcomes of VDR activator treatments in clinical practice is a major challenge in the management of this patient population. The aim of this post-marketing observational study is to obtain further data on the outcomes of Zemplar Injection administration during routine clinical use.

Full description

This study is a non-interventional, observational study in which Zemplar® Injection is prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics (SmPC) with regards to dose, population and indication. The study population consists of participants receiving hemodialysis in whom the diagnosis of secondary hyperparathyroidism has been established, and who are not adequately controlled with the oral VDR activator (calcitriol or alfacalcidol). Participants will be included via consecutive sampling. To be included, participants should have a clinical indication to initiate treatment with Zemplar® Injection due to: (1) a diagnosis of secondary hyperparathyroidism and (2) because they require a change in treatment for secondary hyperparathyroidism (e.g. due to a lack of effectiveness of the previous treatment). Each participant will be observed during his/her Zemplar® Injection treatment regimen for a maximum period of 12 months.

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is more than 18 years of age and diagnosed with secondary hyperparathyroidism and has a pretreatment iPTH > 300 pg/mL, receiving chronic hemodialysis.
• Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.

Exclusion criteria

• Subject has a corrected serum calcium >10.5 mg/dL, serum phosphorus > 6.5 mg/dL or subjects with corrected Ca x P>65.
• Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients, or has participated in clinical study within the last month

Trial design

181 participants in 1 patient group

End stage chronic kidney disease

Description:

Secondary hyperparathyroidism defined as intact PTH \> 300 pg/mL

Treatment:

Drug: Zemplar iv (paricalcitol iv)