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

A Randomized, Active-Controlled, Double-Blind Multi-Center Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00091481

Enrollment

201

Registered

2004-09-13

Start date

2003-06-30

Completion date

Unknown

Last updated

2007-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Keywords

Stage V Chronic Kidney Disease

Brief summary

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).

Interventions

DRUGZemplar

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026