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

Abbott

Status and phase: Completed; Phase 4

Conditions: Kidney Failure, Chronic

Treatments: Drug: Zemplar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00091481

M01-367

Details and patient eligibility

About

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).

Enrollment: 201 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind