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

Completed

• Conditions: ANEMIA

• Registration Number: NCT01903148
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-19
• Results First Submitted: 2013-08-22
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-08
• Last Update Submitted: 2013-11-08
• Results First Posted: 2014-01-01
• Last Update Posted: 2014-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 455

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% Patients Achieving Target Hemoglobin Levels	1 day because is a crosssectional study with only a visit	% patients with Hb levels between 11-12 mg/dl

Secondary Outcome Measures

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

Trial Locations

Locations (29)

Hospital Puerto Real; 🇪🇸 Cadiz, Andalucía, Spain

Clínico V. Victoria; 🇪🇸 Malaga, Andalucía, Spain

Hospital de Jerez; 🇪🇸 Jerez, Andalucía, Spain

Hospital Josep Trueta; 🇪🇸 Gerona, Cataluña, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Marques de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Fundación Puigvert; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Virgen de la Luz; 🇪🇸 Toledo, Castilla la Mancha, Spain

Hospital Bellvige; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Clinic; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Bellvitge; 🇪🇸 Barcelona, Cataluña, Spain

Sagrat Cor; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Valld'Hebron; 🇪🇸 Barcelona, Cataluña, Spain

Clinica Girona; 🇪🇸 Gerona, Cataluña, Spain

Hospital de Castellón; 🇪🇸 Castellón, Comunidad Valenciana, Spain

Hospital General de Alicante; 🇪🇸 Alicante, Comunidad Valenciana, Spain

Complexo Hospitalario de Ourense; 🇪🇸 Orense, Galicia, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Islas Baleares, Spain

Arquitecto Marcide; 🇪🇸 Ferrol, Galicia, Spain

Hospital Dr. Peset; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Complejo Hospitalario Universitario de Santiago; 🇪🇸 Santiago de Compostela, Galicia, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Nuestra Señora De Candelaria; 🇪🇸 Santa Cruz de Tenerife, Islas Canarias, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital La Princesa; 🇪🇸 Madrid, Spain

Hospital La Fe; 🇪🇸 Valencia, Comunidad Valenciana, Spain