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

Phase 4

• Conditions: Disorder of Vitamin D; Kidney Failure, Chronic
• Interventions: Drug: Hidroferol®; Drug: Habitual medication

• Registration Number: NCT01442272
• Lead Sponsor: Hospital Universitario de Canarias

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-09
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Study Start: 2012-01
• Last Update Submitted: 2012-05-18
• Last Update Posted: 2012-05-21
• Primary Completion: 2012-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Habitual medication plus Hidroferol®	Hidroferol®	-
Habitual medication withuot additional	Habitual medication	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hospital Universitario de Canarias; 🇪🇸 La Laguna, S/C Tenerife, Spain

HUC; 🇪🇸 La Laguna, S/c Tenerife, Spain