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

2014-08-27 03:15:24 | BioPortfolio

Summary

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.

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 Ca > 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum P>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P>65 mg2/dL2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring, changes from baseline in chemistry and hematology laboratory variables, and changes from baseline in vital signs.

Study Design

Time Perspective: Prospective

Conditions

Chronic Kidney Failure

Location

Site Reference ID/Investigator# 32050
Athens
Greece
11528

Status

Active, not recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:24-0400

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A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.

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