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Completed

NCT Number: NCT02041208

Variability of Hemoglobin Levels After Kidney Transplantation

The purpose of this study es to determine hemoglobin variability in kidney transplant recipients with chronic renal anemia.

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Key information

Conditions

Renal Anemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario de Albacete, Albacete, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kidney transplantation

Procedure

kidney transplantation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Sociedad Española de Trasplante

Other

Registry information

Official study title

A Retrospective, Observational Study to Evaluate Hemoglobin Variability in Kidney Transplant Recipients With Chronic Renal Anemia.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 20, 2014
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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