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

September 19, 2011 updated by: Abbott

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

181

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Dubrovnik, Croatia, 20000
        • Site Reference ID/Investigator# 27525
      • Imotski, Croatia, 21260
        • Site Reference ID/Investigator# 27531
      • Karlovac, Croatia, 47000
        • Site Reference ID/Investigator# 6175
      • Pula, Croatia, 52100
        • Site Reference ID/Investigator# 27528
      • Rijeka, Croatia, 51000
        • Site Reference ID/Investigator# 27533
      • Sibenik, Croatia, 22000
        • Site Reference ID/Investigator# 27524
      • Sisak, Croatia, 44000
        • Site Reference ID/Investigator# 27523
      • Slavonski Brod, Croatia, 35000
        • Site Reference ID/Investigator# 27529
      • Split, Croatia, 1000
        • Site Reference ID/Investigator# 27530
      • Trogir, Croatia, 21220
        • Site Reference ID/Investigator# 27534
      • Vinkovci, Croatia, 32000
        • Site Reference ID/Investigator# 27522
      • Zadar, Croatia, 23000
        • Site Reference ID/Investigator# 27527
      • Zagreb, Croatia, 10000
        • Site Reference ID/Investigator# 27526
      • Zagreb, Croatia, 10000
        • Site Reference ID/Investigator# 27532
  • Serbia
      • Beograd, Serbia, 11000
        • Site Reference ID/Investigator# 27536
      • Beograd, Serbia, 11000
        • Site Reference ID/Investigator# 27538
      • Beograd, Serbia, 11000
        • Site Reference ID/Investigator# 27539
      • Beograd, Serbia, 11000
        • Site Reference ID/Investigator# 6169
      • Beograd, Serbia, 11080
        • Site Reference ID/Investigator# 27540
      • Bor, Serbia, 19210
        • Site Reference ID/Investigator# 27535
      • Kragujevac, Serbia, 34000
        • Site Reference ID/Investigator# 27537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Haemodialysis patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
End stage chronic kidney disease
Secondary hyperparathyroidism defined as intact PTH > 300 pg/mL
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.
Other Names:
  • Zemplar iv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline
Time Frame: Baseline through 12 months
Baseline through 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL)
Time Frame: Baseline through 12 months
Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit.
Baseline through 12 months
Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL
Time Frame: Baseline through 12 months
The average time (measured in days) to achieve target iPTH levels.
Baseline through 12 months
Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements.
Time Frame: Baseline through 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Marta Gunjaca, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 19, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P10-231

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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