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
  Purpose

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.


Condition Intervention
Parathyroid Hormone
Drug: Zemplar iv (paricalcitol iv)

Study Type: Observational
Study Design: Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 181
Study Start Date: September 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Zemplar iv

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Haemodialysis patients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084538

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01084538     History of Changes
Other Study ID Numbers: P10-231
Study First Received: February 22, 2010
Results First Received: June 30, 2011
Last Updated: September 19, 2011
Health Authority: Croatia: Agency for Medicinal Product and Medical Devices
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Abbott:
paricalcitol iv
vitamin D
secondary hyperparathyroidism
hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 17, 2014