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

November 27, 2013 updated by: Fundación Renal Iñigo Alvarez De Toledo

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Hospital Universitario General de Alicante
      • Barcelona, Spain, 08025
        • Fundacio Puigvert
      • Barcelona, Spain, 08035
        • Hospital Valle de Hebron
      • Córdoba, Spain, 14004
        • Hospital Reina Sofia
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañon
      • Madrid, Spain, 28040
        • Clínico San Carlos
      • Madrid, Spain, 28046
        • Hospital 12 de Octubre
      • Málaga, Spain, 29010
        • Hospital Carlos Haya
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen de la Macarena
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
      • Valencia, Spain, 46017
        • Hospital Dr Peset
      • Zaragoza, Spain, 50009
        • Hospital Clinico Lozano Blesa
    • Barcelona
      • Badalona, Barcelona, Spain, 08035
        • Hospital Germans Trias i Pujol
    • Islas Baleares
      • Mallorca, Islas Baleares, Spain, 07010
        • Hospital Son Espases
    • Islas Canarias
      • Santa Cruz de Tenerife, Islas Canarias, Spain, 38010
        • Hospital Virgen de la Candelaria
    • Lugo
      • Burela, Lugo, Spain, 27880
        • Hospital Comarcal Da Costa
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hosp. U. Fundación de Alcorcón
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta De Hierro
      • San Sebastian de los Reyes, Madrid, Spain, 28702
        • Hospital Infanta Sofia
    • País Vasco
      • Bilbao, País Vasco, Spain, 48960
        • Hospital de Galdakao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paricalcitol, Daily treatment, CKD
Experimental Arm
Drug: Experimental arm
Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)
Other Names:
  • Treatment
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.
Other Names:
  • Daily treatment for CKD
Other: Daily treatment for CKD
Comparator Arm
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.
Other Names:
  • Daily treatment for CKD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline albuminuria at 6 months
Time Frame: 6 months
Determinate % of patients with an over 20% of albuminuria descent from baseline
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Renal Iñigo Alvarez De Toledo

Collaborators

Effice Servicios Para la Investigacion S.L.

Investigators

  • Principal Investigator: Jesús Egido de los Ríos, MD, Fundación Renal Iñigo Alvarez de Toledo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

July 30, 2012

First Submitted That Met QC Criteria

March 25, 2013

First Posted (Estimate)

March 28, 2013

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PALIFE-2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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