Clinical trial NCT02041208: Variability of Hemoglobin Levels After Kidney Transplantation
Official title: A Retrospective, Observational Study to Evaluate Hemoglobin Variability in Kidney Transplant Recipients With Chronic Renal Anemia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Anemia
Keywords: Chronic renal anemia
Hemoglobin
Kidney transplant
Lead sponsor: Sociedad Española de Trasplante
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult kidney transplant recipients with chronic renal anemia.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint of the study is hemoglobin level variability
timeFrame: the study includes the retrospective collection of information from the medical records of patients over a period of one year.
Secondary outcomes:
measure: Estimation of cardiovascular risk of patients
timeFrame: at the end of the study period (one year after the start of data recording)
measure: Potential factors influencing hemoglobin variability
timeFrame: Both baseline data and the changes recorded on the visit at month 12 will be considered.
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Islas Baleares
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: La Coruña
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Fundación Puigvert
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Gran Canaria
country: Spain
facility: Hospital Universitario Dr. Negrín
city: Madrid
country: Spain
facility: Hospital Universitario la Princesa
city: Madrid
country: Spain
facility: Hospital UniversitarioGregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Carlos Haya de Málaga
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
affiliation: Hospital San Carlos, Madrid
name: Ana Sánchez Fructuoso, Coordinator
role: STUDY_CHAIR
affiliation: Hospital Carlos Haya de Málaga
name: Domingo Hernández, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Puerta del Mar
name: Teresa García, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. Central de Asturias
name: Ernesto Gómez Huertas, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario Univ. de Albacete
name: Francisco Llamas Fuentes, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Uni. Marqués de Valdecilla
name: Juan Carlos Ruiz San Millán, Coordinator
role: STUDY_CHAIR
affiliation: Fundación Puigvert
name: Luis Guirado Perich, Coordinator
role: STUDY_CHAIR
affiliation: Hospital Clinic of Barcelona
name: José Vicente Torregrosa, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. Vall d´Hebron
name: Francesc Moreso, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. Germans Trias i Pujol
name: Ricardo Lauzurica Valdemoros, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: María Luisa Mir Fontana, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. de Bellvitge
name: Alberto Martínez Castelao, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario Univ. de Santiago
name: Rafael Romero Burgos, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Espases
name: Gonzalo Gómez, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. Dr. Negrín
name: Roberto Gallego Samper, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital 12 de Octubre
name: Esther González Monte, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. La Paz
name: Carlos Jiménez Martín, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. Gregorio Marañón
name: Manuel Rengel Aranda, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. La Princesa
name: Carmen Bernis, Md.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Univ. de Navarra
name: Pedro Errasti Goenaga, Md.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univ. La Fe
name: Jaime Sánchez Plumed, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario de Alicante
name: Antonio Franco Esteve, Md
role: PRINCIPAL_INVESTIGATOR
References: