Renal AnemiaNCT02041208
Variability of Hemoglobin Levels After Kidney Transplantation
An observational study of Renal Anemia, run by Sociedad Española de Trasplante at 22 sites in Spain.
Trial summary
The purpose of this study es to determine hemoglobin variability in kidney transplant recipients with chronic renal anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Anemia
- What is being tested?
- kidney transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 368 participants
- Where
- 22 sitesSpain
- Study dates
- Mar 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult kidney transplant recipients with chronic renal anemia.
Who may be able to join
- Patients aged > or = 18 years.
- Kidney transplant recipients with chronic renal failure stage 3 (glomerular filtration rate: 30-59ml/min/1.73m2), 4 (glomerular filtration rate: 15-29ml/min/1.73m2) or 5 (glomerular filtration rate: <15ml/min/1.73m2) at the start of the study follow-up period.
- Diagnosis of anemia and drug treatment initiated or changed subsequent to June 29, 2010 (date on which the latest recommendation by European Renal Best Practice on the target range for hemoglobin levels were published)
- Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form.
Who cannot join
- Patients whose medical history lacks measurements of hemoglobin levels every three months (±1 month) during the year of study follow-up.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 sites
Complejo Hospitalario Universitario de Albacete
Albacete, Albacete, 02006
Hospital General de Alicante
Alicante, Alicante, 03010
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, Barcelona, 08003
Fundación Puigvert
Barcelona, Barcelona, 08025
Hospital Universitario Vall d´Hebron
Barcelona, Barcelona, 08035
Hospital Clinic i Provincial
Barcelona, Barcelona, 08036
Hospital Puerta del Mar
Cadiz, Cádiz, 11009
Hospital Universitario Dr. Negrín
Gran Canaria, Gran Canaria, 35010
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario la Princesa
Madrid, Madrid, 28006
Hospital UniversitarioGregorio Marañón
Madrid, Madrid, 28007
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital Carlos Haya de Málaga
Málaga, Málaga, 29010
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33007
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07010
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, 15706
Hospital Universitario La Fe
Valencia, Valencia, 46009
About this study
Official title: A Retrospective, Observational Study to Evaluate Hemoglobin Variability in Kidney Transplant Recipients With Chronic Renal Anemia.
The purpose of this study es to determine hemoglobin variability in kidney transplant recipients with chronic renal anemia.
Read the detailed description
The primary endpoint of the study is hemoglobin level variability. For determination of this variability, the following patterns of hemoglobin level change will be established:
- Target range hemoglobin (TRH): patients with hemoglobin values in the range of 11.0-12.0g/dl throughout the study period.
- Low hemoglobin (LH): patients with levels below 11.0g/dl
- High hemoglobin (HH): patients with levels above 12.0g/dl
- Low-amplitude fluctuation with low hemoglobin (LALH): patients with at least one measurement of hemoglobin levels <11.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements >12.0g/dl.
- Low-amplitude fluctuation with high hemoglobin (LAHH): patients with at least one measurement of hemoglobin levels >12.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements <11.0g/dl.
- High-amplitude fluctuation (HAH): patients with at least one measurement of hemoglobin levels <11.0g/dl and at least one measurement >12.0g/dl.
Secondary objectives:
- To determine potential factors influencing hemoglobin variability.
- To assess the influence of hemoglobin variability on cardiovascular risk of patients according to the REGICOR function at the end of the study period.
- Conditions
- Renal Anemia
- Being tested
- kidney transplantation
- Keywords
- Chronic renal anemia, Hemoglobin, Kidney transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kidney transplantationProcedure or surgery
kidney transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is hemoglobin level variability
For determination of this variability, the following patterns of hemoglobin level change will be established:
- Target range hemoglobin (TRH): patients who maintain hemoglobin values in the range of 11.0-12.0g/dl throughout the study period. - Low hemoglobin (LH): patients with hemoglobin levels below 11.0g/dl.
- High hemoglobin (HH): patients with hemoglobin levels above 12.0g/dl.
- Low-amplitude fluctuation with low hemoglobin (LALH): patients with at least one measurement of hemoglobin levels <11.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements >12.0g/dl.
- Low-amplitude fluctuation with high hemoglobin (LAHH): patients with at least one measurement of hemoglobin levels >12.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements <11.0g/dl.
- High-amplitude fluctuation (HAH): patients with at least one measure of hemoglobin levels <11.0g/dl and at least one measurement >12.0g/dl
Measured: the study includes the retrospective collection of information from the medical records of patients over a period of one year.
Secondary outcomes (2)
Estimation of cardiovascular risk of patients
according to the REGICOR function (acronym Girona Heart Registry)
Measured: at the end of the study period (one year after the start of data recording)
Potential factors influencing hemoglobin variability
Demographic and anthropometric data, comorbidities, concomitant medication, and data on transplant, chronic renal failure, renal anemia treatment and possible hospitalizations.
Measured: Both baseline data and the changes recorded on the visit at month 12 will be considered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Trasplante
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Sánchez Fructuoso, Coordinator, Study chair, Hospital San Carlos, MadridDomingo Hernández, Md, Principal investigator, Hospital Carlos Haya de MálagaTeresa García, Md, Principal investigator, Hospital Universitario Puerta del MarErnesto Gómez Huertas, Md, Principal investigator, Hospital Univ. Central de AsturiasFrancisco Llamas Fuentes, Md, Principal investigator, Complejo Hospitalario Univ. de AlbaceteJuan Carlos Ruiz San Millán, Coordinator, Study chair, Hospital Uni. Marqués de ValdecillaLuis Guirado Perich, Coordinator, Study chair, Fundación PuigvertJosé Vicente Torregrosa, Md, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041208
- Sponsor's protocol ID
- SET-ANE-2011-01
- Status last verified
- Jan 2014
- First submitted
- 19 Dec 2013
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational Study to Evaluate Hemoglobin Variability in Kidney Transplant Recipients With Chronic Renal Anemia.
- ClinicalTrials.gov ID
- NCT02041208
- Acronym / sponsor ID
- SET-ANE-2011-01
- Conditions
- Renal Anemia
- Keywords
- Chronic renal anemia, Hemoglobin, Kidney transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Sociedad Española de TrasplanteUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study es to determine hemoglobin variability in kidney transplant recipients with chronic renal anemia.
Detailed description
The primary endpoint of the study is hemoglobin level variability. For determination of this variability, the following patterns of hemoglobin level change will be established:
- Target range hemoglobin (TRH): patients with hemoglobin values in the range of 11.0-12.0g/dl throughout the study period.
- Low hemoglobin (LH): patients with levels below 11.0g/dl
- High hemoglobin (HH): patients with levels above 12.0g/dl
- Low-amplitude fluctuation with low hemoglobin (LALH): patients with at least one measurement of hemoglobin levels <11.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements >12.0g/dl.
- Low-amplitude fluctuation with high hemoglobin (LAHH): patients with at least one measurement of hemoglobin levels >12.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements <11.0g/dl.
- High-amplitude fluctuation (HAH): patients with at least one measurement of hemoglobin levels <11.0g/dl and at least one measurement >12.0g/dl.
Secondary objectives:
- To determine potential factors influencing hemoglobin variability.
- To assess the influence of hemoglobin variability on cardiovascular risk of patients according to the REGICOR function at the end of the study period.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult kidney transplant recipients with chronic renal anemia.
Key inclusion criteria (4 listed)
- Patients aged > or = 18 years.
- Kidney transplant recipients with chronic renal failure stage 3 (glomerular filtration rate: 30-59ml/min/1.73m2), 4 (glomerular filtration rate: 15-29ml/min/1.73m2) or 5 (glomerular filtration rate: <15ml/min/1.73m2) at the start of the study follow-up period.
- Diagnosis of anemia and drug treatment initiated or changed subsequent to June 29, 2010 (date on which the latest recommendation by European Renal Best Practice on the target range for hemoglobin levels were published)
- Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form.
Key exclusion criteria (1 listed)
- Patients whose medical history lacks measurements of hemoglobin levels every three months (±1 month) during the year of study follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kidney transplantationkidney transplantation | Procedure or surgery | – |
Primary outcome
The primary endpoint of the study is hemoglobin level variability
Time frame: the study includes the retrospective collection of information from the medical records of patients over a period of one year.
For determination of this variability, the following patterns of hemoglobin level change will be established: * Target range hemoglobin (TRH): patients who maintain hemoglobin values in the range of 11.0-12.0g/dl throughout the study period. - Low hemoglobin (LH): patients with hemoglobin levels below 11.0g/dl. * High hemoglobin (HH): patients with hemoglobin levels above 12.0g/dl. * Low-amplitude fluctuation with low hemoglobin (LALH): patients with at least one measurement of hemoglobin levels <11.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements >12.0g/dl. * Low-amplitude fluctuation with high hemoglobin (LAHH): patients with at least one measurement of hemoglobin levels >12.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements <11.0g/dl. * High-amplitude fluctuation (HAH): patients with at least one measure of hemoglobin levels <11.0g/dl and at least one measurement >12.0g/dl
2 secondary outcomes
Estimation of cardiovascular risk of patients
Time frame: at the end of the study period (one year after the start of data recording)
Potential factors influencing hemoglobin variability
Time frame: Both baseline data and the changes recorded on the visit at month 12 will be considered.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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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.
Ana Sánchez Fructuoso, Coordinator study chair
Hospital San Carlos, Madrid
Domingo Hernández, Md principal investigator
Hospital Carlos Haya de Málaga
Teresa García, Md principal investigator
Hospital Universitario Puerta del Mar
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Anemia, run by Sociedad Española de Trasplante at 22 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 4 inclusion and 1 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 20 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 22 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint of the study is hemoglobin level variability (time frame: the study includes the retrospective collection of information from the medical records of patients over a period of one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2014.