A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease
| Status: | Withdrawn |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | July 2006 |
| End Date: | January 2008 |
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.
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.
Objectives:
1. To determine the effect of oral paricalcitol on protein excretion in patients with
proteinuric renal diseases
2. To determine the effect of oral paricalcitol on renal disease progression in patients
with proteinuric renal diseases Hypothesis: Oral paricalcitol will reduce protein
excretion in proteinuric kidney disease Study Design: Prospective, randomized, placebo
controlled, double blind, trial of paricalcitol compared to placebo.
Sample Size: 60 patients, 30 in each group Summary of Patient Eligibility Criteria: Subjects
with proteinuric renal disease (>400 mg/24 hours)
Randomization and Dosage: Patients will be randomized to treatment with oral paricalcitol
(initial dose 1 mcg orally per day) compared to placebo Duration : 6 Months
1. To determine the effect of oral paricalcitol on protein excretion in patients with
proteinuric renal diseases
2. To determine the effect of oral paricalcitol on renal disease progression in patients
with proteinuric renal diseases Hypothesis: Oral paricalcitol will reduce protein
excretion in proteinuric kidney disease Study Design: Prospective, randomized, placebo
controlled, double blind, trial of paricalcitol compared to placebo.
Sample Size: 60 patients, 30 in each group Summary of Patient Eligibility Criteria: Subjects
with proteinuric renal disease (>400 mg/24 hours)
Randomization and Dosage: Patients will be randomized to treatment with oral paricalcitol
(initial dose 1 mcg orally per day) compared to placebo Duration : 6 Months
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
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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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