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Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose

NCT00891813 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-10-31

Study results available
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Summary

The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH\>300pg/mL) and that require dialysis at least 3 times per week.

Conditions

  • Secondary Hyperparathyroidism
  • Renal Insufficiency, Chronic
  • Parathyroid Hormone
  • Hemodialysis
  • Hypercalcemia

Interventions

DRUG

Zemplar (paricalcitol)

Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.

Sponsors & Collaborators

Principal Investigators

  • Oscar E Guerra, MD · Abbott

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Peru

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00891813 on ClinicalTrials.gov