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

NCT ID: NCT01442272

Last Updated: 2012-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-10-31

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.

Detailed Description

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Conditions

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Kidney Failure, Chronic Disorder of Vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Habitual medication withuot additional

Group Type NO_INTERVENTION

Habitual medication

Intervention Type DRUG

Habitual medication

Habitual medication plus Hidroferol®

Group Type ACTIVE_COMPARATOR

Hidroferol®

Intervention Type DRUG

Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months

Habitual medication plus Zemplar®

Group Type ACTIVE_COMPARATOR

Paricalcitol: Zemplar®

Intervention Type DRUG

Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months

Interventions

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Hidroferol®

Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months

Intervention Type DRUG

Paricalcitol: Zemplar®

Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months

Intervention Type DRUG

Habitual medication

Habitual medication

Intervention Type DRUG

Other Intervention Names

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B C A

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario de Canarias

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario de Canarias

San Cristóbal de La Laguna, S/C Tenerife, Spain

Site Status RECRUITING

HUC

San Cristóbal de La Laguna, S/c Tenerife, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ana Aldea

Role: CONTACT

+34922678115

Facility Contacts

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Ana Aldea

Role: primary

+34922678115

ANA ALDEA

Role: primary

+34922678115

Other Identifiers

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NEFROVID2010

Identifier Type: -

Identifier Source: org_study_id

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