Anemia Management in Chronic Kidney Disease Not on Dialysis Patients After the European Renal Best Practice (ERBP) Working Group Recommendations (ACERCA)

November 8, 2013 updated by: Fundación Senefro

ANEMIA MANAGEMENT IN CHRONIC KIDNEY DISEASE NOT ON DIALYSIS PATIENTS AFTER THE ERBP WORKING GROUP RECOMMENDATIONS

The purpose of this study is to evaluate the impact of the last recommendations of the European Anemia Working Group ERBP in the anemia management in the achievement of the therapeutic goal of Hb 11-12 g/dL.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

455

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
      • Madrid, Spain
        • Hospital 12 de octubre
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital La Paz
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital La Princesa
    • Andalucía
      • Cadiz, Andalucía, Spain
        • Hospital Puerto Real
      • Jerez, Andalucía, Spain
        • Hospital de Jerez
      • Malaga, Andalucía, Spain
        • Clínico V. Victoria
    • Cantabria
      • Santander, Cantabria, Spain
        • Hospital Marqués de Valdecilla
    • Castilla la Mancha
      • Toledo, Castilla la Mancha, Spain
        • Hospital Virgen De La Luz
    • Cataluña
      • Barcelona, Cataluña, Spain
        • Hospital Clínic
      • Barcelona, Cataluña, Spain
        • Hospital Bellvitge
      • Barcelona, Cataluña, Spain
        • Fundacion Puigvert
      • Barcelona, Cataluña, Spain
        • Hospital Bellvige
      • Barcelona, Cataluña, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Cataluña, Spain
        • Hospital Valld'Hebron
      • Barcelona, Cataluña, Spain
        • Sagrat Cor
      • Gerona, Cataluña, Spain
        • Clinica Girona
      • Gerona, Cataluña, Spain
        • Hospital Josep Trueta
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain
        • Hospital General de Alicante
      • Castellón, Comunidad Valenciana, Spain
        • Hospital de Castellón
      • Valencia, Comunidad Valenciana, Spain
        • Hospital Clínico de Valencia
      • Valencia, Comunidad Valenciana, Spain
        • Hospital Dr. Peset
      • Valencia, Comunidad Valenciana, Spain
        • Hospital la Fe
    • Galicia
      • Ferrol, Galicia, Spain
        • Arquitecto Marcide
      • Orense, Galicia, Spain
        • Complexo Hospitalario de Ourense
      • Santiago de Compostela, Galicia, Spain
        • Complejo Hospitalario Universitario De Santiago
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain
        • Hospital Son Llatzer
    • Islas Canarias
      • Santa Cruz de Tenerife, Islas Canarias, Spain
        • Hospital Universitario Nuestra Señora de Candelaria

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults patients with anemia secondary to chronic kidney disease (CKD) not on dyalisis.

Description

Inclusion Criteria:

  • Adults patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.
  • Patients starting anemia treatment (naïve) after six months of the last recommendations of the European Anemia Working Group ERBP (January 2011).
  • Patients in treatment who changed from previous ESA treatment since January 2011 (converted patients

Exclusion Criteria:

  • Patients in Erythropoiesis Stimulating Agents (ESA) dose adjustment period.
  • Kidney transplant patients.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% Patients Achieving Target Hemoglobin Levels
Time Frame: 1 day because is a crosssectional study with only a visit
% patients with Hb levels between 11-12 mg/dl
1 day because is a crosssectional study with only a visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin Levels Per Type of Patients
Time Frame: 1 day
levels Hb and type of patients
1 day
Patients With Hb>12
Time Frame: 1 day
1 day
% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy
Time Frame: 1 day
know the treatments ESA for maintenance of hb levels
1 day
Iron Treatment
Time Frame: 1 day
Patients with supplementary Iron treatment to ESA
1 day
Patients With Hb<11
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Fundación Senefro

Investigators

  • Principal Investigator: Alberto Martinez Castelao, Doctor, Hospital Bellvitge
  • Principal Investigator: Aleix Cases, Doctor, Hospital Clinic of Barcelona

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

October 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (Estimate)

July 19, 2013

Study Record Updates

Last Update Posted (Estimate)

January 1, 2014

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEN-AEE-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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