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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Failure Secondary Hyperparathyroidism

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Kidney Disease

All eligible patients treated with IV Paricalcitol (Zemplar)

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No