Status:
COMPLETED
Vascular Reactivity in Chronic Kidney Disease (CKD) Patients Receiving Paricalcitol Versus Placebo
Lead Sponsor:
Amy Barton Pai
Collaborating Sponsors:
Albany College of Pharmacy and Health Sciences
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This research is studying how Vitamin D may affect blood vessels reaction to stress and blood levels of substances that may increase blockages in the blood vessels in chronic kidney disease (CKD) pati...
Eligibility Criteria
Inclusion
- Males or females ≥ 18 years of age at the start of screening
- CKD with eGFR 15-60 mL/min/1.73m2 by MDRD
- Not expected to start dialysis for 4 months
- Serum intact PTH 70-200 pg/mL during screening period
- On stable ACEI/ARB regimen for 30 days prior to screening
Exclusion
- History of any of the following diseases:
- congestive heart failure
- MI within the last 6 months
- history of cerebrovascular accident
- significant valvular disease
- malignancy
- Currently taking any vitamin D products
- Mean systolic blood pressure values \> 190 or diastolic blood pressure values \> 100 mm/Hg during the preceding 30 day period prior to screening
- Currently being titrated on therapy with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker
- Two consecutive serum calcium values greater than 10.2 mg/dL or Ca x P \> 55 mg2/dL2
- Currently receiving erythropoiesis stimulating agent or intravenous iron therapy
- Pregnant or breastfeeding
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00915876
Start Date
March 1 2009
End Date
March 1 2011
Last Update
December 2 2016
Active Locations (1)
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1
Albany Medical Center South Clinical Campus
Albany, New York, United States, 12208