NCT02041208

Variability of Hemoglobin Levels After Kidney Transplantation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 368 (actual)
• Sponsor: Sociedad Española de Trasplante · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Anemia

Interventions

Type	Name	Description
PROCEDURE	kidney transplantation	kidney transplantation

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2014-01-20
• Last updated: 2014-01-20

Locations

22 sites across 1 country: Spain