| Trial ID: | L0178 |
| Source ID: | NCT01680198
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| Associated Drug: |
Paracalcitol
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| Title: |
Paricalcitol and Endothelial Function in Chronic Kidney Disease Patients (the PENNY Study)
|
| Acronym: |
PENNY
|
| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Chronic Kidney Disease.
|
| Interventions: |
DRUG: Paracalcitol|DRUG: placebo
|
| Outcome Measures: |
Primary: Endothelial function measurement, 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 during the 4 min following cuff deflation to estimate endothelium-dependent FMD. In studies of endothelium-independent vasodilatation recording times were 1 min for the baseline assessment and 5 min for changes in arterial diameter brought about by GTN. An interval of at least 1h was set between the last FMD assessment and GTN administration. All scans were recorded, stored and analyzed off-line. FMD and GTN were computed as the maximal % increase in diameter over baseline by an automatic edge detection system., 12 weeks from baseline | Secondary: Endothelial function and plasma/serum and genetic biomarkers of bone mineral disorders in CKD (BMD-CKD) and renin angiotensin-aldosteron system (RAS)., The investigators will analyze 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)., 12 weeks from baseline
|
| Sponsor/Collaborators: |
Sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
88
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-06
|
| Completion Date: |
2012-08
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| Results First Posted: |
|
| Last Update Posted: |
2012-10-02
|
| Locations: |
Nephrology, Dialysis and Transplantation Unit, Reggio Calabria, 89124, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT01680198
|
