Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis

Abbott201 enrolled

Overview

To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

201

Conditions

Kidney Failure, Chronic

Interventions

ZemplarDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stage V Chronic Kidney Disease * Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy

Locations (19)

Errikos Dynan Hospital

Ambelokipi, Athens, Greece

General Hospital of Athens, "G.Gennimatas"

Cholargós, Athens, Greece

Outcomes

Primary Outcomes

Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65.

Secondary Outcomes

Evaluate the number of days to achieve the first of 2 consecutive > or = 30% decreases from baseline in PTH

The incidence rate for hypercalcemia

The incidence rate for hyperphosphatemia

Data from ClinicalTrials.gov

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