Variability of Hemoglobin Levels After Kidney Transplantation

NCT02041208 | Completed

• 1 other identifier: SET-ANE-2011-01
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 22

Brief Summary

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

Conditions

Renal Anemia

Keywords

Chronic renal anemia; Hemoglobin; Kidney transplant

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Estimation of cardiovascular risk of patients

  at the end of the study period (one year after the start of data recording)

• Potential factors influencing hemoglobin variability

  Both baseline data and the changes recorded on the visit at month 12 will be considered.

Interventions

kidney transplantation PROCEDURE

kidney transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult kidney transplant recipients with chronic renal anemia.

You may qualify if:

• 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.

You may not qualify if:

• Patients whose medical history lacks measurements of hemoglobin levels every three months (±1 month) during the year of study follow-up.

Sponsors & Collaborators

• Sociedad Española de Trasplante: lead

Study Sites (22)

Complejo Hospitalario Universitario de Albacete

Albacete, Albacete, 02006, Spain

Location

Hospital General de Alicante

Alicante, Alicante, 03010, Spain

Location

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Fundación Puigvert

Barcelona, Barcelona, 08025, Spain

Location

Hospital Universitario Vall d´Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Puerta del Mar

Cadiz, Cádiz, 11009, Spain

Location

Hospital Universitario Dr. Negrín

Gran Canaria, Gran Canaria, 35010, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital Universitario la Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital UniversitarioGregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Carlos Haya de Málaga

Málaga, Málaga, 29010, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33007, Spain

Location

Hospital Universitario La Fe

Valencia, Valencia, 46009, Spain

Location

MeSH Terms

Interventions

Kidney Transplantation

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Ana Sánchez Fructuoso, Coordinator

  Hospital San Carlos, Madrid

  STUDY CHAIR

• Domingo Hernández, Md

  Hospital Carlos Haya de Málaga

  PRINCIPAL INVESTIGATOR

• Teresa García, Md

  Hospital Universitario Puerta del Mar

  PRINCIPAL INVESTIGATOR

• Ernesto Gómez Huertas, Md

  Hospital Univ. Central de Asturias

  PRINCIPAL INVESTIGATOR

• Francisco Llamas Fuentes, Md

  Complejo Hospitalario Univ. de Albacete

  PRINCIPAL INVESTIGATOR

• Juan Carlos Ruiz San Millán, Coordinator

  Hospital Uni. Marqués de Valdecilla

  STUDY CHAIR

• Luis Guirado Perich, Coordinator

  Fundación Puigvert

  STUDY CHAIR

• José Vicente Torregrosa, Md

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Francesc Moreso, Md

  Hospital Univ. Vall d´Hebron

  PRINCIPAL INVESTIGATOR

• Ricardo Lauzurica Valdemoros, Md

  Hospital Univ. Germans Trias i Pujol

  PRINCIPAL INVESTIGATOR

• María Luisa Mir Fontana, Md

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

• Alberto Martínez Castelao, Md

  Hospital Univ. de Bellvitge

  PRINCIPAL INVESTIGATOR

• Rafael Romero Burgos, Md

  Complejo Hospitalario Univ. de Santiago

  PRINCIPAL INVESTIGATOR

• Gonzalo Gómez, Md

  Hospital Son Espases

  PRINCIPAL INVESTIGATOR

• Roberto Gallego Samper, Md

  Hospital Univ. Dr. Negrín

  PRINCIPAL INVESTIGATOR

• Esther González Monte, Md

  Hospital 12 de Octubre

  PRINCIPAL INVESTIGATOR

• Carlos Jiménez Martín, Md

  Hospital Univ. La Paz

  PRINCIPAL INVESTIGATOR

• Manuel Rengel Aranda, Md

  Hospital Univ. Gregorio Marañón

  PRINCIPAL INVESTIGATOR

• Carmen Bernis, Md.

  Hospital Univ. La Princesa

  PRINCIPAL INVESTIGATOR

• Pedro Errasti Goenaga, Md.

  Clínica Univ. de Navarra

  PRINCIPAL INVESTIGATOR

• Jaime Sánchez Plumed, Md

  Hospital Univ. La Fe

  PRINCIPAL INVESTIGATOR

• Antonio Franco Esteve, Md

  Hospital General Universitario de Alicante

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 20, 2014
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 20, 2014

Record last verified: 2014-01

Locations

ES (22)