Chronic Kidney Disease
Conditions
Keywords
Chronic kidney disease, Vitamin D, Paricalcitol, Placebo, Kidney, Renal, Oxidative Stress, Immune cell function, Glucose, Glucose tolerance
Brief summary
The purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).
Detailed description
Persons with chronic kidney disease (CKD) are at markedly increased risk of death, particularly from cardiovascular disease (CVD). A number of metabolic abnormalities may contribute to adverse health outcomes in CKD, including glucose intolerance, altered immune cell function, and oxidative stress. Each of these metabolic stressors is a known complication of CKD. Since these metabolic abnormalities are also known to contribute to the pathogenesis of cardiovascular disease, they are important potential therapeutic targets in CKD. This study will test whether oral paricalcitol, an active form of vitamin D, will improve glucose tolerance, immune cell function, and reduce oxidative stress in people with stage 3-4 chronic kidney disease.
Interventions
DRUGParicalcitol
Two 1 mcg soft gels by mouth daily for 8 weeks
DRUGPlacebo
Two soft gels by mouth daily for 8 weeks
Sponsors
Abbott
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Estimated glomerular filtration rate of 15-59 mL/min/1.73m2 * Fasting glucose 100-125 mg/dL * 18 years and older
Exclusion criteria
* Diagnosed with diabetes mellitus * Use of diabetes medications (insulin or oral hypoglycemics) * Prior dialysis or transplantation * Planning to leave the area within 6 months * Participation in another clinical trial within 30 days * Treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks * Serum calcium more than 10.2 mg/dL * Pregnancy or breast-feeding * Change in dose (within 8 weeks) of Fibrates, Niacin, ACE inhibitors, Angiotensin receptor blockers, Thiazide diuretics, Beta-blockers, Cholecalciferol or Ergocalciferol * Incontinent of urine * Cancer (other than skin cancer) within 5 years * Tuberculosis * Sarcoidosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Area Under the Curve (AUC) | 8 weeks | Glucose AUC during a 2-hour oral glucose tolerance test |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 2010 through 2011 from Nephrology clinics associated with the University of Washington.
Participants by arm
| Arm | Count |
|---|---|
| Paricalcitol Followed by Placebo Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks. | 11 |
| Placebo Followed by Paricalcitol Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks. | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Paricalcitol Followed by Placebo | Placebo Followed by Paricalcitol | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 10.4 | 65.5 years STANDARD_DEVIATION 13.1 | 65.8 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 22 | 7 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
Primary
Glucose Area Under the Curve (AUC)
Glucose AUC during a 2-hour oral glucose tolerance test
Time frame: 8 weeks
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| During Paricalcitol Treatment | Glucose Area Under the Curve (AUC) | 20817 mg*min/dL | Geometric Coefficient of Variation 1.2 |
| During Placebo Treatment | Glucose Area Under the Curve (AUC) | 21139 mg*min/dL | Geometric Coefficient of Variation 1.2 |