Status:
WITHDRAWN
Effects of Vitamin D on Renal Blood Flow, Proteinuria and Inflammation in Patients With Chronic Kidney Disease
Lead Sponsor:
University of Virginia
Conditions:
Chronic Kidney Disease
Secondary Hyperparathyroidism
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 trea...
Detailed Description
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 an...
Eligibility Criteria
Inclusion
- Adults (ages 18 - 75 years)
- A diagnosis of chronic kidney disease (CKD) with a glomerular filtration rate (GFR) in the range of 20 - 60 ml/min/1.73 m2.
- 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
- A recent diagnosis of secondary hyperparathyroidism of renal origin by the patient's nephrologist scheduled for treatment with an active from of vitamin D.
- Available results for serum intact parathyroid hormone (iPTH), calcium and phosphorus within 6 months from the study enrollment date.
- 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
- GFR less than 20 or greater than 60 ml/min/1.73 m2.
- Treatment with an active form of vitamin D, including Calcitriol (Rocaltrol), Paricalcitol (Zemplar) and Doxercalciferol (Hectorol) within the last 3 months.
- Need for renal replacement therapy within the next three months.
- History of any organ transplantation requiring immunosuppressive therapy.
- Chronic treatment with anti-inflammatory agents including NSAIDs, steroids or cytotoxic agents.
- Diagnoses of primary or tertiary hyperparathyroidism.
- Serum intact parathyroid hormone (PTH) concentration greater than 250 pg/mL.
- Serum calcium greater than 10.4 mg/dL.Serum phosphorous greater than 5 mg/dL.
- Active malignancy.
- History of systemic inflammatory diseases such as, systemic lupus, rheumatoid arthritis or vasculitis.
- History of pulmonary hypertension, intracardiac shunt or unstable cardiopulmonary disease.
- Women who are pregnant.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01426724
Start Date
September 1 2011
End Date
August 1 2013
Last Update
May 21 2014
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908