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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carmine Zoccali, National Research Council, Italy
ClinicalTrials.gov Identifier:
NCT01680198
First received: August 30, 2012
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Chronic Kidney Disease.
Drug: Paracalcitol
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Paricalcitol on Endothelial Function in Chronic Kidney Disease (CKD) Patients (the PENNY Study)

Resource links provided by NLM:


Further study details as provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:

Primary Outcome Measures:
  • Endothelial function measurement [ Time Frame: 12 weeks from baseline ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 88
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Carmine Zoccali, Prof., National Research Council, Italy
ClinicalTrials.gov Identifier: NCT01680198     History of Changes
Other Study ID Numbers: Oct2010PENNYStudy
Study First Received: August 30, 2012
Last Updated: October 1, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by 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
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 31, 2014