Clinical trial NCT01903148: Anemia Management in Chronic Kidney Disease Not on Dialysis Patients After the European Renal Best Practice (ERBP) Working Group Recommendations
Official title: ANEMIA MANAGEMENT IN CHRONIC KIDNEY DISEASE NOT ON DIALYSIS PATIENTS AFTER THE ERBP WORKING GROUP RECOMMENDATIONS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ANEMIA
Keywords: ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS
Lead sponsor: Fundación Senefro
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients with anemia secondary to chronic kidney disease (CKD) not on dyalisis.

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.


Eligibility 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.

Primary outcomes:
measure: % Patients Achieving Target Hemoglobin Levels
timeFrame: 1 day because is a crosssectional study with only a visit
Secondary outcomes:
measure: Hemoglobin Levels Per Type of Patients
timeFrame: 1 day
measure: Patients With Hb>12
timeFrame: 1 day
measure: % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy
timeFrame: 1 day
measure: Iron Treatment
timeFrame: 1 day
measure: Patients With Hb<11
timeFrame: 1 day
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Hospital Puerto Real
state: Andalucía
city: Jerez
country: Spain
facility: Hospital de Jerez
state: Andalucía
city: Malaga
country: Spain
facility: Clínico V. Victoria
state: Andalucía
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
state: Cantabria
city: Toledo
country: Spain
facility: Hospital Virgen de la Luz
state: Castilla la Mancha
city: Barcelona
country: Spain
facility: Fundación Puigvert
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Bellvige
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Bellvitge
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Valld'Hebron
state: Cataluña
city: Barcelona
country: Spain
facility: Sagrat Cor
state: Cataluña
city: Gerona
country: Spain
facility: Clinica Girona
state: Cataluña
city: Gerona
country: Spain
facility: Hospital Josep Trueta
state: Cataluña
city: Alicante
country: Spain
facility: Hospital General de Alicante
state: Comunidad Valenciana
city: Castellón
country: Spain
facility: Hospital de Castellón
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Dr. Peset
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital La Fe
state: Comunidad Valenciana
city: Ferrol
country: Spain
facility: Arquitecto Marcide
state: Galicia
city: Orense
country: Spain
facility: Complexo Hospitalario de Ourense
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: Galicia
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Islas Baleares
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora De Candelaria
state: Islas Canarias
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital La Princesa
Study officials:
affiliation: Hospital Bellvitge
name: Alberto Martinez Castelao, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Aleix Cases, Doctor
role: PRINCIPAL_INVESTIGATOR
References: