Effects of Vitamin D on Renal Blood Flow, Proteinuria and Inflammation in Patients With Chronic Kidney Disease

• Status: Withdrawn
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. Adults (ages 18 - 75 years)

2. A diagnosis of chronic kidney disease (CKD) with a glomerular filtration rate (GFR) in the range of 20 - 60 ml/min/1.73 m2.

3. Proteinuria confirmed at least twice by one of the following (at least one sample within the last 6 months),

• 24-hour urine protein excretion of at least 150 mg/day OR

• spot urine protein to creatinine ratio (PCR) of greater than 0.15 OR

• spot urine albumin to creatinine ratio (ACR) greater than 100 mg/g

4. A recent diagnosis of secondary hyperparathyroidism of renal origin by the patient's nephrologist scheduled for treatment with an active from of vitamin D.

5. Available results for serum intact parathyroid hormone (iPTH), calcium and phosphorus within 6 months from the study enrollment date.

6. Treatment with a stable dose of an angiotensin receptor blocker (ARB), angiotensin converting enzyme inhibitor (ACE-I) or rennin inhibitor within the last 2 months before enrollment in the study.

Exclusion Criteria:

1. GFR less than 20 or greater than 60 ml/min/1.73 m2.

2. Treatment with an active form of vitamin D, including Calcitriol (Rocaltrol), Paricalcitol (Zemplar) and Doxercalciferol (Hectorol) within the last 3 months.

3. Need for renal replacement therapy within the next three months.

4. History of any organ transplantation requiring immunosuppressive therapy.

5. Chronic treatment with anti-inflammatory agents including NSAIDs, steroids or cytotoxic agents.

6. Diagnoses of primary or tertiary hyperparathyroidism.

7. Serum intact parathyroid hormone (PTH) concentration greater than 250 pg/mL.

8. Serum calcium greater than 10.4 mg/dL.Serum phosphorous greater than 5 mg/dL.

9. Active malignancy.

10. History of systemic inflammatory diseases such as, systemic lupus, rheumatoid arthritis or vasculitis.

11. History of pulmonary hypertension, intracardiac shunt or unstable cardiopulmonary disease.

12. Women who are pregnant.