N/A N=41 Randomized Single-blind

Vascular Reactivity in Chronic Kidney Disease (CKD) Patients Receiving Paricalcitol Versus Placebo

Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT00915876 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcome: Primary: Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 — 707; 701; 679; 627 nanogram/ml — p=>0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Paricalcitol (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amy Barton Pai
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56	707; 701; 679; 627; 590; 477	>0.05

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) patients. Blood vessel health is worsened in CKD and some studies have shown that Vitamin D improves blood vessel health. The type of Vitamin D being used in this study (paricalcitol) is Food and Drug Administration (FDA) approved to treat high parathyroid hormone levels. The purpose of this study is to find out if paricalcitol has other benefits beyond its ability to lower parathyroid hormone levels such as improving the blood vessels reaction to stress and decreasing blood levels of substances that may increase blockages in the blood vessels.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00915876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.