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Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study)

NCT ID: NCT01820078

Last Updated: 2013-11-28

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to estimate the differences between albuminuria values determined as Urine Albumin-to-Creatinine Ratio (UACR)(log transformed) from baseline to last observation caused by paricalcitol between the group of control and group of treatment.

Detailed Description

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Clinical Trial to estimate UACR determined albuminuria differences between treatment and non-treatment groups from basal intake to last study-related observation. Patients should suffer proteinuric Chronical Kidney Disease and recovered levels of seric 25(OH)D. Also, this clinical trial tries to determinate the effect of paricalcitol over several metabolic and inflammatory parameters on patients.

Conditions

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Chronic Kidney Disease, Unspecified

Keywords

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Chronic Kidney Disease Proteinuria Albuminuria Paricalcitol

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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Paricalcitol, Daily treatment, CKD

Experimental Arm

Group Type EXPERIMENTAL

Experimental arm

Intervention Type DRUG

Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)

Comparator Arm

Intervention Type OTHER

Daily treatment is not define by protocol, because daily treatment in CKD is highly variable and includes salt and/or blood pressure regulation, angiotensine system stoppers, controlled diet, etc.

Daily treatment for CKD

Comparator Arm

Group Type OTHER

Comparator Arm

Intervention Type OTHER

Daily treatment is not define by protocol, because daily treatment in CKD is highly variable and includes salt and/or blood pressure regulation, angiotensine system stoppers, controlled diet, etc.

Interventions

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Experimental arm

Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)

Intervention Type DRUG

Comparator Arm

Daily treatment is not define by protocol, because daily treatment in CKD is highly variable and includes salt and/or blood pressure regulation, angiotensine system stoppers, controlled diet, etc.

Intervention Type OTHER

Other Intervention Names

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Treatment Daily treatment for CKD

Eligibility Criteria

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Inclusion Criteria

* Informed consent signed
* Patients will be men or women, between 18 and 75 years old.
* Patients must have been taken an stable dosis of Angiotensine Converter Enzyme Inhibitor, Angiotensine Receptor Antagonism or antialdosterone at last 6 months before screening visit.
* Patients should not be on dialysis treatment.
* Women should not be pregnant, or in fertile period (at last 1 year postmenopausal or chirurgic sterilized or using this contraceptive methods: condoms, gel, intrauterine devices, anticonceptives, etc. During at last 3 months after the study beginning.

Exclusion Criteria

* Patients have taken active vitamin D during 6 months after the screening.
* Patients with allergy o sensibility to paricalcitol.
* Patients with acute CKD 12 weeks before the screening.
* Patients with chronical gastrointestinal disease.
* Patients with hypo or hyperthyroidism.
* Patients with secondary hypertension
* Bad controled hypertension patients
* Patients with renal lithiasis
* Patients with drug dependence
* Patients taking calcitonins, biphosphonates, cinacalcet or others Ca-metabolism drugs.
* Patients taking immunosuppressor drugs.
* Patients not adequate to study as medical opinion.
* HIV patients
* Seric P \> 5.0 mg/dl.
* Seric Ca\> 10,0 mg/dl.
* Proteinuria \> 3.500 mg/g
* Hypoalbuminemia \< 3g/dl
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Effice Servicios Para la Investigacion S.L.

INDUSTRY

Sponsor Role collaborator

Fundación Renal Iñigo Alvarez De Toledo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesús Egido de los Ríos, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación Renal Iñigo Alvarez De Toledo

Locations

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Hospital Universitario General de Alicante

Alicante, Alicante, Spain

Site Status

Hospital Son Espases

Mallorca, Balearic Islands, Spain

Site Status

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Fundació Puigvert

Barcelona, Barcelona, Spain

Site Status

Hospital Valle de Hebrón

Barcelona, Barcelona, Spain

Site Status

Hospital de Galdakao

Bilbao, Basque Country, Spain

Site Status

Hospital Virgen de la Candelaria

Santa Cruz de Tenerife, Canary Islands, Spain

Site Status

Hospital Reina Sofía

Córdoba, Córdoba, Spain

Site Status

Hospital Virgen de las Nieves

Granada, Granada, Spain

Site Status

Hospital Comarcal Da Costa

Burela de Cabo, Lugo, Spain

Site Status

Hosp. U. Fundación de Alcorcón

Alcorcón, Madrid, Spain

Site Status

Hospital Gregorio Marañon

Madrid, Madrid, Spain

Site Status

Hospital Ramon y Cajal

Madrid, Madrid, Spain

Site Status

Clínico San Carlos

Madrid, Madrid, Spain

Site Status

Fundación Jiménez Díaz

Madrid, Madrid, Spain

Site Status

Hospital 12 de Octubre

Madrid, Madrid, Spain

Site Status

Hospital Universitario La Paz

Madrid, Madrid, Spain

Site Status

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status

Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, Spain

Site Status

Hospital Carlos Haya

Málaga, Málaga, Spain

Site Status

Hospital Universitario Virgen de la Macarena

Seville, Sevilla, Spain

Site Status

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Site Status

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Site Status

Hospital Dr Peset

Valencia, Valencia, Spain

Site Status

Hospital Clinico Lozano Blesa

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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PALIFE-2011-01

Identifier Type: -

Identifier Source: org_study_id