Chronic Kidney Disease
Conditions
Keywords
chronic kidney disease, Vitamin D
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) 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.
Interventions
DRUGParicalcitol
paricalcitol 1 mcg QD x 8 weeks
DRUGPlacebo
Placebo for Paricalcitol 1 mcg QD x 8 weeks
Sponsors
Albany College of Pharmacy and Health Sciences
Amy Barton Pai
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 | Day 28 and Day 56 | Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks | 20 |
| Paricalcitol Paricalcitol: paricalcitol 1 mcg QD x 8 weeks | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Paricalcitol | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 11 | 64 years STANDARD_DEVIATION 14 | 66 years STANDARD_DEVIATION 13 |
| estimated glomerular filtration rate | 36 mL/min/1.73m2 STANDARD_DEVIATION 11 | 30 mL/min/1.73m2 STANDARD_DEVIATION 9 | 35 mL/min/1.73m2 STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 19 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56
Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56
Time frame: Day 28 and Day 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 | Baseline | 707 nanogram/ml | Standard Deviation 504 |
| Placebo | Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 | Day 28 | 679 nanogram/ml | Standard Deviation 557 |
| Placebo | Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 | Day 56 | 590 nanogram/ml | Standard Deviation 458 |
| Paricalcitol | Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 | Baseline | 701 nanogram/ml | Standard Deviation 603 |
| Paricalcitol | Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 | Day 28 | 627 nanogram/ml | Standard Deviation 570 |
| Paricalcitol | Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 | Day 56 | 477 nanogram/ml | Standard Deviation 382 |
p-value: >0.05ANOVA