Value Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D

Study Overview
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Brief Summary
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The purpose of this study is to determine the value the additional antiproteinuric effects of vitamin D derivatives treatment, in patients with Chronic Kidney Illness phase II-IV, with lack of vitamin D and residual proteinuria higher 0,5 grams/day.

Official Title
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Clinical Trial, Open, Parallel Groups , Value the Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D

Conditions
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Kidney Failure, Chronic, Disorder of Vitamin D

Intervention / Treatment
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* Drug: Hidroferol®
* Drug: Paricalcitol: Zemplar®
* Drug: Habitual medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/female Patients older 18 years old Patients have signed written informed consent Chronic Kidney Illness phase II-IV plus residual proteinuria >0,5 grams/day (two or more consecutive occasions) and plus beta blockers treatment from AARS during al least 3 months. Serum levels of calcifediol in the lack of level (15-30 ng/ml). Exclusion Criteria: Bad control of high blood pressure (higher or same 180/110 mmHg) Bad control of diabetes (HbA1c higher 9,5 in the last three months period) Hypercalcemia (<10,2 mg/dL) o hyperphosphatemia(>5,5 mg/dL), CaxPO4>50, hypercalciuria (urin Ca/Cr quotient > 0,15) Vitamin D treatment or any analogous Hepatic failure ( AST o ALT > 3 times higher than normal limit) medical history of poor nutrient intestinal absorptions or chronic diarrhea Active nephrolithiasis Treatment with medication wich can change vitamin D metabolism (phenobarbital, phenytoin, rifampicin) Participation in other Clinic Trial in 3 last months Active Alcoholism Neoplasia precedent (except cutaneous no melanoma) Pregnant women or while breastfeeding Vitamin D hypersensitivity or any its excipient hypersensitivity Any other condition from Research

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Habitual medication withuot additional<br> | Drug: Habitual medication<br>* Habitual medication<br>* Other names: A;|
| Active Comparator: Habitual medication plus Hidroferol®<br> | Drug: Hidroferol®<br>* Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months<br>* Other names: B;|
| Active Comparator: Habitual medication plus Zemplar®<br> | Drug: Paricalcitol: Zemplar®<br>* Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months<br>* Other names: C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein/creatinine quotient and albumin/creatinine in matinal urine sample: basal and 3 period months after a month of the therapeutic protocol beginning. |  | 1-3 month |