Variability of Hemoglobin Levels After Kidney Transplantation

January 17, 2014 updated by: Sociedad Española de Trasplante

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

368

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Complejo Hospitalario Universitario de Albacete
      • Alicante, Spain, 03010
        • Hospital General de Alicante
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial
      • Barcelona, Spain, 08025
        • Fundacion Puigvert
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d´Hebron
      • Cádiz, Spain, 11009
        • Hospital Puerta del Mar
      • Gran Canaria, Spain, 35010
        • Hospital Universitario Dr. Negrin
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital UniversitarioGregorio Marañón
      • Málaga, Spain, 29010
        • Hospital Carlos Haya De Malaga
      • Valencia, Spain, 46009
        • Hospital Universitario La Fe
    • Asturias
      • Oviedo, Asturias, Spain, 33007
        • Hospital Universitario Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07010
        • Hospital Son Espases
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult kidney transplant recipients with chronic renal anemia.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients whose medical history lacks measurements of hemoglobin levels every three months (±1 month) during the year of study follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
the study includes the retrospective collection of information from the medical records of patients over a period of one year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of cardiovascular risk of patients
Time Frame: at the end of the study period (one year after the start of data recording)
according to the REGICOR function (acronym Girona Heart Registry)
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.
Demographic and anthropometric data, comorbidities, concomitant medication, and data on transplant, chronic renal failure, renal anemia treatment and possible hospitalizations.
Both baseline data and the changes recorded on the visit at month 12 will be considered.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Trasplante

Investigators

  • Study Chair: Ana Sánchez Fructuoso, Coordinator, Hospital San Carlos, Madrid
  • Principal Investigator: Domingo Hernández, Md, Hospital Carlos Haya De Malaga
  • Principal Investigator: Teresa García, Md, Hospital Universitario Puerta Del Mar
  • Principal Investigator: Ernesto Gómez Huertas, Md, Hospital Univ. Central de Asturias
  • Principal Investigator: Francisco Llamas Fuentes, Md, Complejo Hospitalario Univ. de Albacete
  • Study Chair: Juan Carlos Ruiz San Millán, Coordinator, Hospital Uni. Marqués de Valdecilla
  • Study Chair: Luis Guirado Perich, Coordinator, Fundacion Puigvert
  • Principal Investigator: José Vicente Torregrosa, Md, Hospital Clinic of Barcelona
  • Principal Investigator: Francesc Moreso, Md, Hospital Univ. Vall d´Hebron
  • Principal Investigator: Ricardo Lauzurica Valdemoros, Md, Hospital Univ. Germans Trias I Pujol
  • Principal Investigator: María Luisa Mir Fontana, Md, Hospital del Mar
  • Principal Investigator: Alberto Martínez Castelao, Md, Hospital Univ. de Bellvitge
  • Principal Investigator: Rafael Romero Burgos, Md, Complejo Hospitalario Univ. De Santiago
  • Principal Investigator: Gonzalo Gómez, MD, Hospital Son Espases
  • Principal Investigator: Roberto Gallego Samper, Md, Hospital Univ. Dr. Negrín
  • Principal Investigator: Esther González Monte, Md, Hospital 12 de Octubre
  • Principal Investigator: Carlos Jiménez Martín, Md, Hospital Univ. La Paz
  • Principal Investigator: Manuel Rengel Aranda, Md, Hospital Univ. Gregorio Marañon
  • Principal Investigator: Carmen Bernis, Md., Hospital Univ. La Princesa
  • Principal Investigator: Pedro Errasti Goenaga, Md., Clinica Univ. de Navarra
  • Principal Investigator: Jaime Sánchez Plumed, Md, Hospital Univ. La Fe
  • Principal Investigator: Antonio Franco Esteve, Md, Hospital General Universitario de Alicante

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Estimate)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SET-ANE-2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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