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

Phase 4

Terminated

• Conditions: Chronic Kidney Disease, Unspecified
• Interventions: Other: Comparator Arm; Drug: Experimental arm

• Registration Number: NCT01820078
• Lead Sponsor: Fundación Renal Iñigo Alvarez De Toledo

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Primary Completion: 2013-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-11-28
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily treatment for CKD	Comparator Arm	Comparator Arm
Paricalcitol, Daily treatment, CKD	Experimental arm	Experimental Arm
Paricalcitol, Daily treatment, CKD	Comparator Arm	Experimental Arm

Primary Outcome Measures

Name	Time	Method
Albuminuria in proteinuric Chronical Kidney Disease patients	1 year	Estimate differences between groups based on albuminuric level determined as UACR from basal to last observation visit.

Secondary Outcome Measures

Name	Time	Method
Change from baseline albuminuria at 6 months	6 months	Determinate % of patients with an over 20% of albuminuria descent from baseline

Trial Locations

Locations (25)

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Fundació Puigvert; 🇪🇸 Barcelona, Spain

Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario General de Alicante; 🇪🇸 Alicante, Spain

Hospital Carlos Haya; 🇪🇸 Málaga, Spain

Hospital Virgen de la Candelaria; 🇪🇸 Santa Cruz de Tenerife, Islas Canarias, Spain

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hosp. U. Fundación de Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

Hospital Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Son Espases; 🇪🇸 Mallorca, Islas Baleares, Spain

Hospital Valle de Hebrón; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen de la Macarena; 🇪🇸 Sevilla, Spain

Hospital de Galdakao; 🇪🇸 Bilbao, País Vasco, Spain

Hospital Infanta Sofía; 🇪🇸 San Sebastian de los Reyes, Madrid, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Clinico Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Dr Peset; 🇪🇸 Valencia, Spain

Hospital Comarcal Da Costa; 🇪🇸 Burela, Lugo, Spain