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.

Study Overview

• Status: Completed
• Conditions: Secondary Hyperparathyroidism; Chronic Kidney Failure

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.

• Study Type: Observational
• Enrollment (Actual): 237

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11526
    • Site Reference ID/Investigator# 32055
  • Athens, Greece, 11528
    • Site Reference ID/Investigator# 32050
  • Athens, Greece, 11528
    • Site Reference ID/Investigator# 32051
  • Athens, Greece, 17237
    • Site Reference ID/Investigator# 32049
  • Athens, Greece
    • Site Reference ID/Investigator# 5283
  • Chalkida, Greece, 34100
    • Site Reference ID/Investigator# 32056
  • Chania, Greece, 73100
    • Site Reference ID/Investigator# 32057
  • Drama, Greece, 66100
    • Site Reference ID/Investigator# 32058
  • Holargos, Greece, 15562
    • Site Reference ID/Investigator# 32077
  • Katerini, Greece, 60100
    • Site Reference ID/Investigator# 32076
  • Kavala, Greece, 65201
    • Site Reference ID/Investigator# 32059
  • Komotini, Greece, 69100
    • Site Reference ID/Investigator# 32053
  • Lamia, Greece, 35100
    • Site Reference ID/Investigator# 32060
  • Lefkada, Greece, 31100
    • Site Reference ID/Investigator# 32061
  • Livadia, Greece, 32100
    • Site Reference ID/Investigator# 32062
  • Pireus, Greece
    • Site Reference ID/Investigator# 32048
  • Preveza, Greece, 48100
    • Site Reference ID/Investigator# 32054
  • Ptolemaida, Greece, 50200
    • Site Reference ID/Investigator# 32063
  • Volos, Greece, 38222
    • Site Reference ID/Investigator# 32075

Participation Criteria

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

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic Kidney Disease; All eligible patients treated with IV Paricalcitol (Zemplar)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations	The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.	Baseline to Month 24 Visit
Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized	The mean (average) number of days hospitalized per participant for those hospitalized during the study.	Baseline to Month 24 Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)	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.	Baseline to Month 24 Visit
The Incidence of Clinically Significant Hypercalcemia	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.	Baseline to Month 24 Visit
The Incidence of Clinically Significant Hyperphosphatemia	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.	Baseline to Month 24 Visit
The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product	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.	Baseline to Month 24 Visit
To Estimate the Incidence of (S)AEs/(S)ADRs	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.	Baseline to Month 24 Visit

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Chair: Konstantinos Xynos, MD, Abbott Laboratories Hellas S.A.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 27, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Estimate): March 27, 2012
• Last Update Submitted That Met QC Criteria: March 26, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Chronic Kidney Failure; Secondary Hyperparathyroidism; Paricalcitol IV treatment; Safety and efficacy assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Parathyroid Diseases; Neoplastic Processes; Renal Insufficiency, Chronic; Hyperparathyroidism; Neoplasm Metastasis; Kidney Failure, Chronic; Renal Insufficiency; Hyperparathyroidism, Secondary
• Other Study ID Numbers: P06-120