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Paricalcitol Effect on Anemia in CKD

NCT01768351 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-07-30

No results posted yet for this study

Summary

Current activated Vitamin D therapies are approved for treating secondary hyperparathyroidism in chronic kidney disease (CKD), and a large body of experimental data in animals confirms the effects of Vitamin D that extend beyond mineral metabolism. Several studies show that the benefits are greater with the newer vitamin D analog paricalcitol when compared with calcitriol. A large gap exists in our knowledge between epidemiological studies in human that demonstrate improved outcomes with vitamin D use and observations in preclinical studies demonstrating the pleiotropic effects of Vitamin D. To explore the provenance of epidemiological outcomes in CKD, we conducted a pilot randomized trial to determine whether the use of paricalcitol, compared to calcitriol, leads to improvement in anemia, a marker associated with worse outcomes in chronic kidney disease, and whether this effect not only reflects the hyperparathyroidism correction, but is also dependent on the direct effects of paricalcitol on erythroid progenitor cells.

Conditions

Interventions

DRUG

Paricalcitol

Zemplar cp 1 mcg/day per os

DRUG

Calcitriol

Rocaltrol cp 0,5 mcg every other day per os

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Eleonora Riccio, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-03-31
Completion
2012-10-31

Countries

  • Italy

Study Locations

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Entities

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 NCT01768351 on ClinicalTrials.gov