MedTrace Logo

Paricalcitol and Endothelial Function in Chronic Kidney Disease Patients (the PENNY Study)

NCT01680198 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2012-10-02

No results posted yet for this study

Summary

The primary aim of this study was to test the hypothesis that Paricalcitol, an active form of vitamin D, improved endothelial function in stage 3-4 chronic kidney disease (CKD) patients. A secondary aim of this trial was to study the relationship between endothelial function and plasma/serum and genetic biomarkers of bone mineral disorders in CKD (BMD-CKD) and renin angiotensin-aldosteron system (RAS) (angiotensin II and plasma renin activity).

Conditions

  • Chronic Kidney Disease.

Interventions

DRUG

Paracalcitol

Patients in the experimental arm received 2 micrograms Paricalcitol capsules daily, for 12 weeks. This dose was adjusted based on clinical laboratory parameters and the maximum dose was 2 micrograms daily.

DRUG

placebo

Sponsors & Collaborators

  • Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

    lead OTHER_GOV

Principal Investigators

  • Giuseppe Curatola, MD · Nephrology, Dialysis and Transplantation Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT01680198 on ClinicalTrials.gov