A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

• Status: Withdrawn
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetic Nephropathy and other proteinuric renal diseases are the major cause of kidney disease in the United States. The degree of proteinuria is associated with risk for renal disease progression and cardiovascular outcomes. Deficiency of 1-25 Vitamin D develops early in CKD, and is undertreated. Vitamin D may have important effects on factors that drive proteinuria and renal disease progression in patients with proteinuric renal diseases. Therefore, Paricalcitol treatment may reduce proteinuria and slow renal deterioration.

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

Details

• Lead Sponsor: Winthrop University Hospital
• Treatments: Ergocalciferols

Criteria

Inclusion Criteria:

1. Stable chronic kidney disease

2. Urine protein : Creatinine ratio > 0.4

3. Chronic kidney disease stage 2-4 with eGFR 15-90 ml/min

4. PTH (intact) >20 pg/ml and <250 pg/ml

5. Age 18-85

6. If on ACEI/ARB, then dose optimized (BP, K)

Exclusion Criteria:

1. Failure to provide informed consent

2. Glomerunephritis requiring active treatment with immunosuppresive therapy

3. Serum phosphorus > 5.2

4. Serum calcium (adjusted for albumin)> 10.0

5. Active malignancy

6. Likelihood of requiring renal replacement therapy within 1 year

7. Uncontrolled hypertension