Variability of Hemoglobin Levels After Kidney Transplantation
- Conditions
- Renal Anemia
- Registration Number
- NCT02041208
- Lead Sponsor
- Sociedad Española de Trasplante
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 368
- 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.
- Patients whose medical history lacks measurements of hemoglobin levels every three months (±1 month) during the year of study follow-up.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is hemoglobin level variability 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 Outcome Measures
Name Time Method Estimation of cardiovascular risk of patients at the end of the study period (one year after the start of data recording) according to the REGICOR function (acronym Girona Heart Registry)
Potential factors influencing hemoglobin variability 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.
Trial Locations
- Locations (22)
Hospital Universitario de Bellvitge
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital Universitario Vall d´Hebron
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Fundación Puigvert
🇪🇸Barcelona, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Islas Baleares, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, La Coruña, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Complejo Hospitalario Universitario de Albacete
🇪🇸Albacete, Spain
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital Universitario Dr. Negrín
🇪🇸Gran Canaria, Spain
Hospital Puerta del Mar
🇪🇸Cádiz, Spain
Hospital UniversitarioGregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario la Princesa
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Carlos Haya de Málaga
🇪🇸Málaga, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital del Mar
🇪🇸Barcelona, Spain