NCT01903148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Shorter than P25 for all trials

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 1, 2014

Completed
Last Updated

January 1, 2014

Status Verified

November 1, 2013

Enrollment Period

8 months

First QC Date

July 12, 2013

Results QC Date

August 22, 2013

Last Update Submit

November 8, 2013

Conditions

ANEMIA

Keywords

ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS

Outcome Measures

Primary Outcomes (1)

  • % 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

Secondary Outcomes (5)

  • Hemoglobin Levels Per Type of Patients

    1 day

  • Patients With Hb>12

    1 day

  • % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy

    1 day

  • Iron Treatment

    1 day

  • Patients With Hb<11

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Hospital Puerto Real

Cadiz, Andalusia, Spain

Location

Hospital de Jerez

Jerez de la Frontera, Andalusia, Spain

Location

Clínico V. Victoria

Málaga, Andalusia, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Location

Hospital Universitario Nuestra Señora De Candelaria

Santa Cruz de Tenerife, Canary Islands, Spain

Location

Hospital Marques de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Virgen de la Luz

Toledo, Castille-La Mancha, Spain

Location

Fundación Puigvert

Barcelona, Catalonia, Spain

Location

Hospital Bellvige

Barcelona, Catalonia, Spain

Location

Hospital Bellvitge

Barcelona, Catalonia, Spain

Location

Hospital Clinic

Barcelona, Catalonia, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Catalonia, Spain

Location

Hospital Valld'Hebron

Barcelona, Catalonia, Spain

Location

Sagrat Cor

Barcelona, Catalonia, Spain

Location

Clinica Girona

Girona, Catalonia, Spain

Location

Hospital Josep Trueta

Girona, Catalonia, Spain

Location

Arquitecto Marcide

Ferrol, Galicia, Spain

Location

Complexo Hospitalario de Ourense

Ourense, Galicia, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Galicia, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Location

Hospital Gregorio Marañón

Madrid, Madrid, Spain

Location

Hospital La Paz

Madrid, Madrid, Spain

Location

Hospital La Princesa

Madrid, Madrid, Spain

Location

Hospital General de Alicante

Alicante, Valencia, Spain

Location

Hospital de Castellón

Castellon, Valencia, Spain

Location

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Location

Hospital Dr. Peset

Valencia, Valencia, Spain

Location

Hospital La Fe

Valencia, Valencia, Spain

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Dr. Alberto Martínez Castelao
Organization
Hospital de Bellvitge
albertomcastelao@gmail.com
610 459 262

Study Officials

  • Alberto Martinez Castelao, Doctor

    Hospital Bellvitge

    PRINCIPAL INVESTIGATOR

  • Aleix Cases, Doctor

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2013

First Posted

July 19, 2013

Study Start

October 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

January 1, 2014

Results First Posted

January 1, 2014

Record last verified: 2013-11

Locations

ES(29)