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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
• Treatments: Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Patients with iPTH level > 65 pg/ml; Ca between 8.4- 10.00 mg/dL and P between 2.9-4.5

• Negative serum pregnancy test for female subjects of childbering potential.

• Informed consent.

Exclusion Criteria:

• Use vitamin D supplements.

• Altered liver function tests (bilirubin, aminotransferases and total alkaline phosphatase > 3 times the upper limit of normal ranges).

• Sympthomatic cardiovascular disease on the basis of clinical history. Cancer.