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The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4

NCT00497146 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2013-03-12

Study results available
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Summary

To evaluate the effects of paricalcitol capsules on cardiac structure and function over 48 weeks in patients with Stage 3/4 chronic kidney disease (CKD) who had left ventricular hypertrophy (LVH).

Conditions

Interventions

DRUG

paricalcitol

2 µg capsule

DRUG

placebo

placebo capsule

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Ann Eldred, MD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-09-30
Completion
2012-03-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00497146 on ClinicalTrials.gov