NCT01680198: PENNY

Effect of Paricalcitol on Endothelial Function in Chronic Kidney Disease (CKD) Patients (the PENNY Study)

Completed Phase 3 Last updated 1 October 2012

What this trial tests

Phase 3 trial testing Paracalcitol in Chronic Kidney Disease. in 88 participants. Completed in 1 August 2012.

Timeline

1 June 2011

Primary endpoint
1 August 2012

1 August 2012

Quick facts

Lead sponsor	Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	88
Start date	1 June 2011
Primary completion	1 August 2012
Estimated completion	1 August 2012
Sites	1 location across Italy

Drugs / interventions tested

• Paracalcitol — full drug profile →
• placebo

Conditions studied

• Chronic Kidney Disease. — all drugs for Chronic Kidney Disease. →

Sponsor

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy — full company profile →

Who can join

Adults 18 to 80, any sex, with Chronic Kidney Disease.. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Endothelial function measurement
  Time frame: 12 weeks from baseline
  Endothelial-dependent and independent vasodilation was assessed by a Toshiba Nemia XG Echo-Doppler applying a 7.5 MHz transducer that was fixed by an adjustable stereotactic clamp to warrant image stability. After baseline recording (1 min) a standard sphygmomanometer was placed on the right forearm 2 cm below the elbow and the cuff was inflated to 250 mmHg for 5 min. Recordings were performed dur

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Paricalcitol and endothelial function in chronic kidney disease trial.
   Zoccali C, Curatola G, Panuccio V, Tripepi R, et al · · 2014 · cited 95× · PMID 25259743 · DOI 10.1161/hypertensionaha.114.03748
2. FGF23 and the PTH response to paricalcitol in chronic kidney disease.
   D'Arrigo G, Pizzini P, Cutrupi S, Tripepi R, et al · · 2020 · cited 10× · PMID 31863599 · DOI 10.1111/eci.13196
3. Serum phosphate modifies the vascular response to vitamin D receptor activation in chronic kidney disease (CKD) patients.
   Zoccali C, Torino C, Curatola G, Panuccio V, et al · · 2016 · cited 9× · PMID 27113290 · DOI 10.1016/j.numecd.2016.03.008
4. Circulating adiponectin modifies the FGF23 response to vitamin D receptor activation: a post hoc analysis of a double-blind, randomized clinical trial.
   Spoto B, Pizzini P, Tripepi G, Mallamaci F, et al · · 2018 · cited 8× · PMID 29304245 · DOI 10.1093/ndt/gfx344
5. Vitamin D receptor activation raises soluble thrombomodulin levels in chronic kidney disease patients: a double blind, randomized trial.
   D'arrigo G, Pizzini P, Cutrupi S, Tripepi R, et al · · 2019 · cited 6× · PMID 29668990 · DOI 10.1093/ndt/gfy085
6. Effect of Vitamin D Receptor Activation on the AGE/RAGE System and Myeloperoxidase in Chronic Kidney Disease Patients.
   Torino C, Pizzini P, Cutrupi S, Tripepi R, et al · · 2017 · cited 5× · PMID 29362665 · DOI 10.1155/2017/2801324
7. Vitamin D and methylarginines in chronic kidney disease (CKD).
   Torino C, Pizzini P, Cutrupi S, Tripepi R, et al · · 2017 · cited 5× · PMID 28976989 · DOI 10.1371/journal.pone.0185449