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

Chronic Kidney Disease, Unspecified Clinical Trial

— PALIFE  

Official title:

Effect of Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study): a Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01820078
• Other study ID #: PALIFE-2011-01
• Status: Terminated
• Phase: Phase 4
• First received: July 30, 2012
• Last updated: November 27, 2013
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2013
• Source: Fundación Renal Iñigo Alvarez De Toledo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 127
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Albuminuria
• Chronic Kidney Disease, Unspecified
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• Experimental arm
Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)

Other:
• 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.

Locations

Country	Name	City	State
Spain	Hosp. U. Fundación de Alcorcón	Alcorcón	Madrid
Spain	Hospital Universitario General de Alicante	Alicante
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Fundació Puigvert	Barcelona
Spain	Hospital Valle de Hebrón	Barcelona
Spain	Hospital de Galdakao	Bilbao	País Vasco
Spain	Hospital Comarcal Da Costa	Burela	Lugo
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Virgen de las Nieves	Granada
Spain	Clínico San Carlos	Madrid
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Gregorio Marañon	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Carlos Haya	Málaga
Spain	Hospital Son Espases	Mallorca	Islas Baleares
Spain	Hospital Infanta Sofía	San Sebastian de los Reyes	Madrid
Spain	Hospital Virgen de la Candelaria	Santa Cruz de Tenerife	Islas Canarias
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Dr Peset	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Clinico Lozano Blesa	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Renal Iñigo Alvarez De Toledo	Effice Servicios Para la Investigacion S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Albuminuria in proteinuric Chronical Kidney Disease patients	Estimate differences between groups based on albuminuric level determined as UACR from basal to last observation visit.	1 year	Yes
Secondary	Change from baseline albuminuria at 6 months	Determinate % of patients with an over 20% of albuminuria descent from baseline	6 months	No