An interventional study of Contrast Enhanced Ultrasonography in Chronic Kidney Disease and Secondary Hyperparathyroidism, sponsored by University of Virginia. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-05-21.
Sponsored by University of Virginia · Not applicable and Interventional
Active forms of vitamin D and its analogs are used to treat elevated parathyroid hormone levels and bone disease in chronic kidney disease (CKD). More recent animal and human studies suggest that treatment with vitamin D may be associated with reduction of inflammation and urinary protein loss as well as reduction the activity of the renin angiotensin system (RAS) in addition to its effects on the bone metabolism. The investigators of this study have used the new technique of contrast enhanced ultrasound (CEU) to measure the flow of blood to the kidney in other human studies. In this study, the investigators will investigate if 3 month of treatment with an active form of vitamin D in individuals with kidney disease and high parathyroid hormone levels would reduce protein loss in the urine. The investigators will also look at the potential changes in blood flow to the kidney using CEU, kidney function (GFR), inflammation and activity of RAS in response to treatment with active form of vitamin D. Finally, they will examine the association between reduction of protein loss in the urine as shown in other studies with any of the other factors measured (e.g, change in blood flow or inflammation).
Screening visit, (Day 1) Most subjects will be contacted during their visit to the Kidney Center Clinic. In some cases, subjects are identified a few days after their visit with their nephrologists and once their laboratory results are available. If a subject is eligible for participation in the study, screening visit will occur at the Nephrology Clinical Research Center located right next to the Kidney Center Clinic. The following will occur during the screening visit,
Visit 2 (Day 2 - 7).
A urine sample will be collected and will be tested for,
Blood samples will be collected at the time of IV catheter placement. These samples will be checked for baseline concentrations of ,
After three months of treatment with one form of vitamin D, the subjects will return to the CRU for the following procedures,
Visit 3 (day 83 - 107) 90 ± 10 days after visit 1
A urine sample will be collected and will be tested for,
Blood samples will be collected at the time of IV catheter placement. These samples will be checked for baseline concentrations of ,
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Proteinuria confirmed at least twice by one of the following (at least one sample within the last 6 months),
Exclusion Criteria:
Definity microbubbles will be infused intravenously at a rate of 2mL/min. contrast enhanced images of the kidneys will be obtained during the infusion and following the destruction of microbubbles within the kidney tissue with ultrasound to measure renal blood flow two times within a 90 day (plus or minus 10 day) window
Change in proteinuria compared to baseline as determined by spot urine protein to creatinine ratio (PCR)
The pre to post-intervention change in urinary protein to creatinine ratio (PCR) will be analyzed either by way of the common paired Students t-test or the by way of paired Wilcoxon test. The paired Student t-test will be utilized if the measurements of the pre to post-intervention change in PCR are normally distribution, otherwise the ranked based paired Wilcoxon test will be utilized.
Time frame: Subjects must be on Vitamin D for 90 days (plus or minus 10 days)
Change in renal blood flow compared to baseline as determined by contrast enhanced ultrasound.
Baseline RBF will be measured using contrast enhanced ultrasound. subjects will be treated with one of the active forms of vitamin D for 90 days. Measurement of RBF usinf CEU will be repeated. Same statisticak methods will be used for this outcome as the primary outcome of the study.
Time frame: Subjects must be on Vitamin D for 90 days (plus or minus 10 days)
Association between changes from baseline in PCR and RBF
We will examine whether the pre-intervention to post-intervention changes in PCR were associated with changes in either renal blood flow. Spearman rank correlations and Spearman partial-rank correlations will be utilized to examine possible associations. With regard to hypothesis testing, the null hypothesis of no association will be rejected based on a p≤0.05 decision rule.
Time frame: Subjects must be on Vitamin D for 90 days (plus or minus 10 days)
Association between changes from baseline in PCR and GFR
We will examine whether the pre-intervention to post-intervention changes in PCR were associated with changes in GFR. Spearman rank correlations and Spearman partial-rank correlations will be utilized to examine possible associations. With regard to hypothesis testing, the null hypothesis of no association will be rejected based on a p≤0.05 decision rule.
Time frame: Subjects must be on Vitamin D for 90 days (plus or minus 10 days)
Association between changes from baseline in PCR and concentration of biomarkers of inflammation
We will examine whether the pre-intervention to post-intervention changes in PCR were associated with changes in CRP, IL-1, IL-6, or TNF-alpha. Spearman rank correlations and Spearman partial-rank correlations will be utilized to examine possible associations. With regard to hypothesis testing, the null hypothesis of no association will be rejected based on a p≤0.05 decision rule.
Time frame: Subjects must be on Vitamin D for 90 days (plus or minus 10 days)
Association between changes from baseline in PCR and activity of the renin angiotensin system.
We will examine whether the pre-intervention to post-intervention changes in PCR were associated with changes in plasma renin-activity and plasma aldosterone concentration. Spearman rank correlations and Spearman partial-rank correlations will be utilized to examine possible associations. With regard to hypothesis testing, the null hypothesis of no association will be rejected based on a p≤0.05 decision rule.
Time frame: Subjects must be on Vitamin D for 90 days (plus or minus 10 days)
This study is withdrawn, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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