Clinical trial NCT01820078: Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study)
Official title: Effect of Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study): a Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Kidney Disease, Unspecified
Keywords: Chronic
Kidney
Disease
Proteinuria
Albuminuria
Paricalcitol
Lead sponsor: Fundación Renal Iñigo Alvarez De Toledo
Sponsor class: OTHER
Collaborators: name: Effice Servicios Para la Investigacion S.L.
First posted: 2013-03-28
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Albuminuria in proteinuric Chronical Kidney Disease patients
timeFrame: 1 year
Secondary outcomes:
measure: Change from baseline albuminuria at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Mallorca
country: Spain
facility: Hospital Son Espases
state: Islas Baleares
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Virgen de la Candelaria
state: Islas Canarias
city: Burela
country: Spain
facility: Hospital Comarcal Da Costa
state: Lugo
city: Alcorcón
country: Spain
facility: Hosp. U. Fundación de Alcorcón
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: San Sebastian de los Reyes
country: Spain
facility: Hospital Infanta Sofía
state: Madrid
city: Bilbao
country: Spain
facility: Hospital de Galdakao
state: País Vasco
city: Alicante
country: Spain
facility: Hospital Universitario General de Alicante
city: Barcelona
country: Spain
facility: Fundació Puigvert
city: Barcelona
country: Spain
facility: Hospital Valle de Hebrón
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Clínico San Carlos
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Dr Peset
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa
Study officials:
affiliation: Fundación Renal Iñigo Alvarez De Toledo
name: Jesús Egido de los Ríos, MD
role: PRINCIPAL_INVESTIGATOR
References: