Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00053547

Enrollment

Registered

2003-02-03

Start date

2002-01-31

Completion date

Unknown

Last updated

2006-08-02

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

Conditions

End Stage Renal Disease, Secondary Hyperparathyroidism

Brief summary

The purpose of this study is to see if Zemplar, a vitamin D medication, safely and effectively decreases parathyroid hormone in children ages 2-20 with End Stage Renal Disease.

Interventions

DRUGparicalcitol injection

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Years to 20 Years

Healthy volunteers

Inclusion criteria

Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism

Design outcomes

Primary

Measure	Time frame
Proportion of subjects achieving at least a 30% decrease from baseline iPTH sustained for at least two consecutive iPTH measurements.	—

Secondary

Measure	Time frame
Proportion of subjects in each group who achieve two consecutive iPTH values below 300 pg/mL.	—

Countries

United States

Outcome results

None listed

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