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The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5

NCT00616902 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-01-20

Study results available
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Summary

To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).

Conditions

  • Chronic Kidney Disease (CKD) Stage 5
  • Hypertrophy, Left Ventricular

Interventions

DRUG

paricalcitol injection 4 mcg/mL

Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis

DRUG

Placebo Injection 4 mcg/mL

Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis

Sponsors & Collaborators

Principal Investigators

  • Dennis Andress, MD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States
  • Australia
  • Czechia
  • Germany
  • Greece
  • Italy
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Spain
  • Taiwan
  • United Kingdom

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 NCT00616902 on ClinicalTrials.gov