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
  Purpose

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.


Condition
Chronic Kidney Failure
Secondary Hyperparathyroidism

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 237
Study Start Date: December 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Kidney Disease
All eligible patients treated with IV Paricalcitol (Zemplar)

Detailed Description:

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.

  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

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081665

Locations
Greece
Site Reference ID/Investigator# 32051
Athens, Greece, 11528
Site Reference ID/Investigator# 5283
Athens, Greece
Site Reference ID/Investigator# 32055
Athens, Greece, 11526
Site Reference ID/Investigator# 32050
Athens, Greece, 11528
Site Reference ID/Investigator# 32049
Athens, Greece, 17237
Site Reference ID/Investigator# 32056
Chalkida, Greece, 34100
Site Reference ID/Investigator# 32057
Chania, Greece, 73100
Site Reference ID/Investigator# 32058
Drama, Greece, 66100
Site Reference ID/Investigator# 32077
Holargos, Greece, 15562
Site Reference ID/Investigator# 32076
Katerini, Greece, 60100
Site Reference ID/Investigator# 32059
Kavala, Greece, 65201
Site Reference ID/Investigator# 32053
Komotini, Greece, 69100
Site Reference ID/Investigator# 32060
Lamia, Greece, 35100
Site Reference ID/Investigator# 32061
Lefkada, Greece, 31100
Site Reference ID/Investigator# 32062
Livadia, Greece, 32100
Site Reference ID/Investigator# 32048
Pireus, Greece
Site Reference ID/Investigator# 32054
Preveza, Greece, 48100
Site Reference ID/Investigator# 32063
Ptolemaida, Greece, 50200
Site Reference ID/Investigator# 32075
Volos, Greece, 38222
Sponsors and Collaborators
Abbott
Investigators
Study Chair: Konstantinos Xynos, MD Abbott Laboratories Hellas S.A.
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01081665     History of Changes
Other Study ID Numbers: P06-120
Study First Received: February 27, 2010
Results First Received: February 7, 2012
Last Updated: March 26, 2012
Health Authority: Greece: National Organization of Medicines

Keywords provided by Abbott:
Chronic Kidney Failure
Secondary Hyperparathyroidism
Paricalcitol IV treatment
Safety and efficacy assessment

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on April 16, 2014