ANEMIAACERCANCT01903148

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

An observational study of ANEMIA, run by Fundación Senefro at 29 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: ANEMIA
How many people: 455 participants
Where: 29 sitesSpain
Study dates: Oct 2011to Jun 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

Spain29 sites

Hospital General de Alicante
Alicante, Valencia
Fundación Puigvert
Barcelona, Catalonia
Hospital Bellvige
Barcelona, Catalonia
Hospital Bellvitge
Barcelona, Catalonia
Hospital Clinic
Barcelona, Catalonia
Hospital Germans Trias i Pujol
Barcelona, Catalonia
Hospital Valld'Hebron
Barcelona, Catalonia
Sagrat Cor
Barcelona, Catalonia
Hospital Puerto Real
Cadiz, Andalusia
Hospital de Castellón
Castellon, Valencia
Arquitecto Marcide
Ferrol, Galicia
Clinica Girona
Girona, Catalonia
Hospital Josep Trueta
Girona, Catalonia
Hospital de Jerez
Jerez de la Frontera, Andalusia
Hospital 12 de Octubre
Madrid, Madrid
Hospital Clínico San Carlos
Madrid, Madrid
Hospital Gregorio Marañón
Madrid, Madrid
Hospital La Paz
Madrid, Madrid
Hospital La Princesa
Madrid, Madrid
Clínico V. Victoria
Málaga, Andalusia
Complexo Hospitalario de Ourense
Ourense, Galicia
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands
Hospital Universitario Nuestra Señora De Candelaria
Santa Cruz de Tenerife, Canary Islands
Hospital Marques de Valdecilla
Santander, Cantabria
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Galicia
Hospital Virgen de la Luz
Toledo, Castille-La Mancha
Hospital Clínico de Valencia
Valencia, Valencia
Hospital Dr. Peset
Valencia, Valencia
Hospital La Fe
Valencia, Valencia

Other trials in Spain

About this study

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

Conditions: ANEMIA
Keywords: ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS
Medical subject headings: Anemia

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Jun 2012

First posted19 Jul 2013 (estimated)
Study startOct 2011
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ANEMIAStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 455 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01903148
Sponsor's protocol ID: SEN-AEE-2011-01
Acronym: ACERCA
Status last verified: Nov 2013
First submitted: 12 Jul 2013
Last updated: 1 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

All ANEMIA trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ANEMIA MANAGEMENT IN CHRONIC KIDNEY DISEASE NOT ON DIALYSIS PATIENTS AFTER THE ERBP WORKING GROUP RECOMMENDATIONS
ClinicalTrials.gov ID: NCT01903148
Acronym / sponsor ID: ACERCA / SEN-AEE-2011-01
Conditions: ANEMIA
Keywords: ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS
Study type: Observational
Recruitment status: Completed
Enrolment: 455 participants (actual)
Lead sponsor: Fundación SenefroUniversity, hospital or other
Study start: Oct 2011
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 19 Jul 2013 (estimated)
Results: Posted 1 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults patients with anemia secondary to chronic kidney disease (CKD) not on dyalisis.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

% 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

5 secondary outcomes

Hemoglobin Levels Per Type of Patients
Time frame: 1 day
Patients With Hb>12
Time frame: 1 day
% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy
Time frame: 1 day
Iron Treatment
Time frame: 1 day
Patients With Hb<11
Time frame: 1 day

Results and safety

Results posted to the registry on 1 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Anemia and CKD	441	441

Primary outcome: % Patients Achieving Target Hemoglobin Levels

Time frame: 1 day because is a crosssectional study with only a visit. Number. Unit: percentage of participants

Measure	Converted Patients n = 143	Naïve Patients n = 298
Value	42.5 (1.3)	35.3 (1.3)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0.6% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Converted Patients	1 of 143 (0.7%)	3 of 143 (2.1%)	Not reported
Naïve Patients	1 of 298 (0.3%)	1 of 298 (0.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for ANEMIA

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alberto Martinez Castelao, Doctor principal investigator

Hospital Bellvitge

Aleix Cases, Doctor principal investigator

Hospital Clinic of Barcelona

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of ANEMIA, run by Fundación Senefro at 29 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% Patients Achieving Target Hemoglobin Levels (time frame: 1 day because is a crosssectional study with only a visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01903148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2014.