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

Parathyroid Hormone Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084538
• Other study ID #: P10-231
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: September 19, 2011
• Start date: September 2007
• Est. completion date: June 2010

Study information

• Verified date: September 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Agency for Medicinal Product and Medical DevicesSerbia and Montenegro: Agency for Drugs and Medicinal Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Diseases
• Parathyroid Hormone
• Renal Insufficiency, Chronic

Intervention

Drug:
• Zemplar iv (paricalcitol iv)
Each patient will be treated at the physician's discretion. Zemplar (paricalcitol) will be prescribed in the usual manner in accordance with the approved Summary of Product Characteristics.

Locations

Country	Name	City	State
Croatia	Site Reference ID/Investigator# 27525	Dubrovnik
Croatia	Site Reference ID/Investigator# 27531	Imotski
Croatia	Site Reference ID/Investigator# 6175	Karlovac
Croatia	Site Reference ID/Investigator# 27528	Pula
Croatia	Site Reference ID/Investigator# 27533	Rijeka
Croatia	Site Reference ID/Investigator# 27524	Sibenik
Croatia	Site Reference ID/Investigator# 27523	Sisak
Croatia	Site Reference ID/Investigator# 27529	Slavonski Brod
Croatia	Site Reference ID/Investigator# 27530	Split
Croatia	Site Reference ID/Investigator# 27534	Trogir
Croatia	Site Reference ID/Investigator# 27522	Vinkovci
Croatia	Site Reference ID/Investigator# 27527	Zadar
Croatia	Site Reference ID/Investigator# 27526	Zagreb
Croatia	Site Reference ID/Investigator# 27532	Zagreb
Serbia	Site Reference ID/Investigator# 27536	Beograd
Serbia	Site Reference ID/Investigator# 27538	Beograd
Serbia	Site Reference ID/Investigator# 27539	Beograd
Serbia	Site Reference ID/Investigator# 27540	Beograd
Serbia	Site Reference ID/Investigator# 6169	Beograd
Serbia	Site Reference ID/Investigator# 27535	Bor
Serbia	Site Reference ID/Investigator# 27537	Kragujevac

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

Croatia,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline		Baseline through 12 months	No
Secondary	Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL)	Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit.	Baseline through 12 months	No
Secondary	Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL	The average time (measured in days) to achieve target iPTH levels.	Baseline through 12 months	No
Secondary	Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements.	Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study.	Baseline through 12 months	Yes