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

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ClinicalTrials.gov Identifier: NCT01903148
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : January 1, 2014
Last Update Posted : January 1, 2014
Sponsor:
Information provided by (Responsible Party):
Fundación Senefro

Brief Summary:
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.

Condition or disease
ANEMIA

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Study Type : Observational
Actual Enrollment : 455 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: ANEMIA MANAGEMENT IN CHRONIC KIDNEY DISEASE NOT ON DIALYSIS PATIENTS AFTER THE ERBP WORKING GROUP RECOMMENDATIONS
Study Start Date : October 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. % 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


Secondary Outcome Measures :
  1. Hemoglobin Levels Per Type of Patients [ Time Frame: 1 day ]
    levels Hb and type of patients

  2. Patients With Hb>12 [ Time Frame: 1 day ]
  3. % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy [ Time Frame: 1 day ]
    know the treatments ESA for maintenance of hb levels

  4. Iron Treatment [ Time Frame: 1 day ]
    Patients with supplementary Iron treatment to ESA

  5. Patients With Hb<11 [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults patients with anemia secondary to chronic kidney disease (CKD) not on dyalisis.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903148


Locations
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Spain
Hospital Puerto Real
Cadiz, Andalucía, Spain
Hospital de Jerez
Jerez, Andalucía, Spain
Clínico V. Victoria
Malaga, Andalucía, Spain
Hospital Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Virgen de la Luz
Toledo, Castilla la Mancha, Spain
Fundación Puigvert
Barcelona, Cataluña, Spain
Hospital Bellvige
Barcelona, Cataluña, Spain
Hospital Bellvitge
Barcelona, Cataluña, Spain
Hospital Clinic
Barcelona, Cataluña, Spain
Hospital Germans Trias i Pujol
Barcelona, Cataluña, Spain
Hospital Valld'Hebron
Barcelona, Cataluña, Spain
Sagrat Cor
Barcelona, Cataluña, Spain
Clinica Girona
Gerona, Cataluña, Spain
Hospital Josep Trueta
Gerona, Cataluña, Spain
Hospital General de Alicante
Alicante, Comunidad Valenciana, Spain
Hospital de Castellón
Castellón, Comunidad Valenciana, Spain
Hospital Clínico de Valencia
Valencia, Comunidad Valenciana, Spain
Hospital Dr. Peset
Valencia, Comunidad Valenciana, Spain
Hospital La Fe
Valencia, Comunidad Valenciana, Spain
Arquitecto Marcide
Ferrol, Galicia, Spain
Complexo Hospitalario de Ourense
Orense, Galicia, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Hospital Son Llatzer
Palma de Mallorca, Islas Baleares, Spain
Hospital Universitario Nuestra Señora De Candelaria
Santa Cruz de Tenerife, Islas Canarias, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital La Princesa
Madrid, Spain
Sponsors and Collaborators
Fundación Senefro
Investigators
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Principal Investigator: Alberto Martinez Castelao, Doctor Hospital Bellvitge
Principal Investigator: Aleix Cases, Doctor Hospital Clinic of Barcelona

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Responsible Party: Fundación Senefro
ClinicalTrials.gov Identifier: NCT01903148     History of Changes
Other Study ID Numbers: SEN-AEE-2011-01
First Posted: July 19, 2013    Key Record Dates
Results First Posted: January 1, 2014
Last Update Posted: January 1, 2014
Last Verified: November 2013

Keywords provided by Fundación Senefro:
ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency