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

Primary Purpose

Chronic Kidney Disease, Unspecified

Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Experimental arm
Comparator Arm
Sponsored by
Fundación Renal Iñigo Alvarez De Toledo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease, Unspecified focused on measuring Chronic, Kidney, Disease, Proteinuria, Albuminuria, Paricalcitol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Germans Trias i Pujol
  • Hospital Son Espases
  • Hospital Virgen de la Candelaria
  • Hospital Comarcal Da Costa
  • Hosp. U. Fundación de Alcorcón
  • Hospital Universitario Puerta de Hierro
  • Hospital Infanta Sofía
  • Hospital de Galdakao
  • Hospital Universitario General de Alicante
  • Fundació Puigvert
  • Hospital Valle de Hebrón
  • Hospital Reina Sofía
  • Hospital Virgen de las Nieves
  • Hospital Gregorio Marañon
  • Hospital Ramon y Cajal
  • Clínico San Carlos
  • Fundación Jiménez Díaz
  • Hospital 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Carlos Haya
  • Hospital Universitario Virgen de la Macarena
  • Hospital Universitario Virgen del Rocío
  • Hospital General Universitario de Valencia
  • Hospital Dr Peset
  • Hospital Clinico Lozano Blesa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Paricalcitol, Daily treatment, CKD

Daily treatment for CKD

Arm Description

Experimental Arm

Comparator Arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 30, 2012
Last Updated
November 27, 2013
Sponsor
Fundación Renal Iñigo Alvarez De Toledo
Collaborators
Effice Servicios Para la Investigacion S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT01820078
Brief Title
Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study)
Acronym
PALIFE
Official Title
Effect of Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study): a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Recruitment not reached
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Renal Iñigo Alvarez De Toledo
Collaborators
Effice Servicios Para la Investigacion S.L.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Unspecified
Keywords
Chronic, Kidney, Disease, Proteinuria, Albuminuria, Paricalcitol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol, Daily treatment, CKD
Arm Type
Experimental
Arm Description
Experimental Arm
Arm Title
Daily treatment for CKD
Arm Type
Other
Arm Description
Comparator Arm
Intervention Type
Drug
Intervention Name(s)
Experimental arm
Other Intervention Name(s)
Treatment
Intervention Description
Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)
Intervention Type
Other
Intervention Name(s)
Comparator Arm
Other Intervention Name(s)
Daily treatment for CKD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Albuminuria in proteinuric Chronical Kidney Disease patients
Description
Estimate differences between groups based on albuminuric level determined as UACR from basal to last observation visit.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change from baseline albuminuria at 6 months
Description
Determinate % of patients with an over 20% of albuminuria descent from baseline
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús Egido de los Ríos, MD
Organizational Affiliation
Fundación Renal Iñigo Alvarez De Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Son Espases
City
Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Hospital Virgen de la Candelaria
City
Santa Cruz de Tenerife
State/Province
Islas Canarias
ZIP/Postal Code
38010
Country
Spain
Facility Name
Hospital Comarcal Da Costa
City
Burela
State/Province
Lugo
ZIP/Postal Code
27880
Country
Spain
Facility Name
Hosp. U. Fundación de Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Infanta Sofía
City
San Sebastian de los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Hospital de Galdakao
City
Bilbao
State/Province
País Vasco
ZIP/Postal Code
48960
Country
Spain
Facility Name
Hospital Universitario General de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Fundació Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Valle de Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Carlos Haya
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Dr Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Clinico Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

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

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