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

ANEMIA Clinical Trial

— ACERCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903148
• Other study ID #: SEN-AEE-2011-01
• Status: Completed
• Phase: N/A
• First received: July 12, 2013
• Last updated: November 8, 2013
• Start date: October 2011
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: Fundación Senefro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• ANEMIA
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Spain	Hospital General de Alicante	Alicante	Comunidad Valenciana
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	Hospital Puerto Real	Cadiz	Andalucía
Spain	Hospital de Castellón	Castellón	Comunidad Valenciana
Spain	Arquitecto Marcide	Ferrol	Galicia
Spain	Clinica Girona	Gerona	Cataluña
Spain	Hospital Josep Trueta	Gerona	Cataluña
Spain	Hospital de Jerez	Jerez	Andalucía
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	Clínico V. Victoria	Malaga	Andalucía
Spain	Complexo Hospitalario de Ourense	Orense	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 Marques de Valdecilla	Santander	Cantabria
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	Galicia
Spain	Hospital Virgen de la Luz	Toledo	Castilla la Mancha
Spain	Hospital Clínico de Valencia	Valencia	Comunidad Valenciana
Spain	Hospital Dr. Peset	Valencia	Comunidad Valenciana
Spain	Hospital La Fe	Valencia	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Senefro

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Patients Achieving Target Hemoglobin Levels	% patients with Hb levels between 11-12 mg/dl	1 day because is a crosssectional study with only a visit	No
Secondary	Hemoglobin Levels Per Type of Patients	levels Hb and type of patients	1 day	No
Secondary	Patients With Hb>12		1 day	No
Secondary	% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy	know the treatments ESA for maintenance of hb levels	1 day	No
Secondary	Iron Treatment	Patients with supplementary Iron treatment to ESA	1 day	No
Secondary	Patients With Hb<11		1 day	No