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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01084538
First received: February 22, 2010
Last updated: September 19, 2011
Last verified: September 2011

February 22, 2010
September 19, 2011
September 2007
June 2010   (final data collection date for primary outcome measure)
Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]
Percentage of subjects achieving at least a 40% reduction of i-PTH (intact parathormone) from baseline after 12 months follow up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01084538 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL) [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]
    Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit.
  • 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 ] [ Designated as safety issue: No ]
    The average time (measured in days) to achieve target iPTH levels.
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • Proportion of subjects achieving serum iPTH level < 300 pg/mL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time (measured in weeks) to achieve iPTH levels < 300 pg/mL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Haemodialysis patients

Parathyroid Hormone
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 Name: Zemplar iv
End stage chronic kidney disease
Secondary hyperparathyroidism defined as intact PTH > 300 pg/mL
Intervention: Drug: Zemplar iv (paricalcitol iv)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Croatia,   Serbia
 
NCT01084538
P10-231
No
Abbott
Abbott
Not Provided
Study Director: Marta Gunjaca, MD Abbott
Abbott
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP