Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01081665
First received: February 27, 2010
Last updated: March 26, 2012
Last verified: March 2012

February 27, 2010
March 26, 2012
December 2006
February 2011   (final data collection date for primary outcome measure)
  • Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations [ Time Frame: Baseline to Month 24 Visit ] [ Designated as safety issue: Yes ]
    The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.
  • Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized [ Time Frame: Baseline to Month 24 Visit ] [ Designated as safety issue: Yes ]
    The mean (average) number of days hospitalized per participant for those hospitalized during the study.
  • Paricalcitol Efficacy by assessing the PTH level changes [ Time Frame: Every month for 2 years ] [ Designated as safety issue: No ]
  • Safety evaluation of Paricalcitol by recording the number of hospitalizations and days hospitalized [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01081665 on ClinicalTrials.gov Archive Site
  • The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml) [ Time Frame: Baseline to Month 24 Visit ] [ Designated as safety issue: No ]
    Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.
  • The Incidence of Clinically Significant Hypercalcemia [ Time Frame: Baseline to Month 24 Visit ] [ Designated as safety issue: Yes ]
    The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.
  • The Incidence of Clinically Significant Hyperphosphatemia [ Time Frame: Baseline to Month 24 Visit ] [ Designated as safety issue: Yes ]
    The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.
  • The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product [ Time Frame: Baseline to Month 24 Visit ] [ Designated as safety issue: Yes ]
    The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.
  • To Estimate the Incidence of (S)AEs/(S)ADRs [ Time Frame: Baseline to Month 24 Visit ] [ Designated as safety issue: Yes ]
    The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.
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Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
A Two-year, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Haemodialysis, Receiving Zemplar for Prevention and Treatment of Secondary Hyperparathyroidism

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.

The primary objective of this study is to evaluate the safety of Zemplar® in the treatment of Secondary hyperparathyroidism (iParathormone>300 pg/mL) in subjects on hemodialysis treated in conditions of usual clinical care.

The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.

A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:

  • 40% reduction in the base iPTH level is achieved, and/or;
  • serum iParathormone level < 300 pg/mL.

Additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (Ca) > 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (P)>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P>65 mg^2/dL^2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics

  • Chronic Kidney Failure
  • Secondary Hyperparathyroidism
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Chronic Kidney Disease
All eligible patients treated with IV Paricalcitol (Zemplar)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
237
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is >= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone > 300 pg/mL.
  • Subject is receiving chronic hemodialysis.
  • Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
  • Subject has provided their informed consent to participate.

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 mg^2/dl^2.
  • Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
  • Subject has participated in clinical study within the last month.
  • Zemplar is contraindicated according to the Summary of Product Characteristics.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01081665
P06-120
Not Provided
Abbott
Abbott
Not Provided
Study Chair: Konstantinos Xynos, MD Abbott Laboratories Hellas S.A.
Abbott
March 2012

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