CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 88 enrolled
Drug / intervention
Paracalcitol +1 moredrug
Likely dose
Paracalcitol 2 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01680198
NCT01680198Phase 3Completed
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Effect of Paricalcitol on Endothelial Function in Chronic Kidney Disease (CKD) Patients (the PENNY Study)

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy·interventional·Posted Sep 7, 2012·Updated Oct 2, 2012

In Brief

A Phase 3 clinical trial evaluating Paracalcitol and placebo for Chronic Kidney Disease.. Completed, enrolled 88 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease.
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2012
Enrollment StartJun 1, 2011
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.8 years ago

Interventions

Paracalcitoldrug

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.

placebodrug