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

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ClinicalTrials.gov Identifier: NCT01680198
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Carmine Zoccali, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Brief 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).

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease. Drug: Paracalcitol Drug: placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Paricalcitol on Endothelial Function in Chronic Kidney Disease (CKD) Patients (the PENNY Study)
Study Start Date : June 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsules daily for 12 weeks.
Drug: placebo
Experimental: Paracalcitol
see "Intervention description" for details.
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.
Other Name: Active form of Vitamin D.



Primary Outcome Measures :
  1. 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 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.


Secondary Outcome Measures :
  1. Endothelial function and plasma/serum and genetic biomarkers of bone mineral disorders in CKD (BMD-CKD) and renin angiotensin-aldosteron system (RAS). [ Time Frame: 12 weeks from baseline ]
    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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680198


Locations
Italy
Nephrology, Dialysis and Transplantation Unit
Reggio Calabria, Italy, 89124
Sponsors and Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Investigators
Study Director: Giuseppe Curatola, MD Nephrology, Dialysis and Transplantation Unit

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carmine Zoccali, Prof., Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
ClinicalTrials.gov Identifier: NCT01680198     History of Changes
Other Study ID Numbers: Oct2010PENNYStudy
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: October 2, 2012
Last Verified: October 2012

Keywords provided by Carmine Zoccali, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:
Vitamin D
Paracalcitol
Chronic kidney disease
Endothelial dysfunction
Flow mediated vasodilation

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamins
Vitamin D
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents