Clinical trial NCT01084538: Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis
Official title: A One-year, Multicountry, Multicenter Study of Zemplar Injections in Patients With End Stage Chronic Kidney Disease, Undergoing Hemodialysis, Not Adequately Controlled With Oral Vitamin D Receptor Activator (Calcitriol or Alfacalcidol)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parathyroid Hormone
Keywords: paricalcitol iv
vitamin D
secondary hyperparathyroidism
hemodialysis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Haemodialysis patients

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline
timeFrame: Baseline through 12 months
Secondary outcomes:
measure: Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL)
timeFrame: Baseline through 12 months
measure: Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL
timeFrame: Baseline through 12 months
measure: Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements.
timeFrame: Baseline through 12 months
Other outcomes:
Locations:
city: Dubrovnik
country: Croatia
facility: Site Reference ID/Investigator# 27525
city: Imotski
country: Croatia
facility: Site Reference ID/Investigator# 27531
city: Karlovac
country: Croatia
facility: Site Reference ID/Investigator# 6175
city: Pula
country: Croatia
facility: Site Reference ID/Investigator# 27528
city: Rijeka
country: Croatia
facility: Site Reference ID/Investigator# 27533
city: Sibenik
country: Croatia
facility: Site Reference ID/Investigator# 27524
city: Sisak
country: Croatia
facility: Site Reference ID/Investigator# 27523
city: Slavonski Brod
country: Croatia
facility: Site Reference ID/Investigator# 27529
city: Split
country: Croatia
facility: Site Reference ID/Investigator# 27530
city: Trogir
country: Croatia
facility: Site Reference ID/Investigator# 27534
city: Vinkovci
country: Croatia
facility: Site Reference ID/Investigator# 27522
city: Zadar
country: Croatia
facility: Site Reference ID/Investigator# 27527
city: Zagreb
country: Croatia
facility: Site Reference ID/Investigator# 27526
city: Zagreb
country: Croatia
facility: Site Reference ID/Investigator# 27532
city: Beograd
country: Serbia
facility: Site Reference ID/Investigator# 27536
city: Beograd
country: Serbia
facility: Site Reference ID/Investigator# 27538
city: Beograd
country: Serbia
facility: Site Reference ID/Investigator# 27539
city: Beograd
country: Serbia
facility: Site Reference ID/Investigator# 6169
city: Beograd
country: Serbia
facility: Site Reference ID/Investigator# 27540
city: Bor
country: Serbia
facility: Site Reference ID/Investigator# 27535
city: Kragujevac
country: Serbia
facility: Site Reference ID/Investigator# 27537
Study officials:
affiliation: Abbott
name: Marta Gunjaca, MD
role: STUDY_DIRECTOR
References: