Variability of Hemoglobin Levels After Kidney Transplantation

Renal Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041208
• Other study ID #: SET-ANE-2011-01
• Status: Completed
• Phase: N/A
• First received: December 19, 2013
• Last updated: January 17, 2014
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: January 2014
• Source: Sociedad Española de Trasplante
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Renal Anemia

Intervention

Procedure:
• kidney transplantation
kidney transplantation

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Albacete	Albacete
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Fundación Puigvert	Barcelona
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Vall d´Hebron	Barcelona
Spain	Hospital Puerta del Mar	Cádiz
Spain	Hospital Universitario Dr. Negrín	Gran Canaria
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario la Princesa	Madrid
Spain	Hospital UniversitarioGregorio Marañón	Madrid
Spain	Hospital Carlos Haya de Málaga	Málaga
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Son Espases	Palma de Mallorca	Islas Baleares
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	La Coruña
Spain	Hospital Universitario La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Española de Trasplante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the study includes the retrospective collection of information from the medical records of patients over a period of one year.	No
Secondary	Estimation of cardiovascular risk of patients	according to the REGICOR function (acronym Girona Heart Registry)	at the end of the study period (one year after the start of data recording)	Yes
Secondary	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.	Both baseline data and the changes recorded on the visit at month 12 will be considered.	No