Kidney transplantation i Nyreanæmi - Kliniske forsøgsregister

Studieoversigt

Status

Afsluttet

Betingelser

Nyreanæmi

Intervention / Behandling

Procedure: kidney transplantation

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

368

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Spanien
- - Albacete, Spanien, 02006
    - Complejo Hospitalario Universitario de Albacete
  - Alicante, Spanien, 03010
    - Hospital General de Alicante
  - Barcelona, Spanien, 08003
    - Hospital del Mar
  - Barcelona, Spanien, 08036
    - Hospital Clinic I Provincial
  - Barcelona, Spanien, 08025
    - Fundación Puigvert
  - Barcelona, Spanien, 08035
    - Hospital Universitario Vall d´Hebron
  - Cádiz, Spanien, 11009
    - Hospital Puerta del Mar
  - Gran Canaria, Spanien, 35010
    - Hospital Universitario Dr. Negrín
  - Madrid, Spanien, 28006
    - Hospital Universitario la Princesa
  - Madrid, Spanien, 28040
    - Hospital Clinico San Carlos
  - Madrid, Spanien, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spanien, 28046
    - Hospital Universitario La Paz
  - Madrid, Spanien, 28007
    - Hospital UniversitarioGregorio Marañón
  - Málaga, Spanien, 29010
    - Hospital Carlos Haya De Malaga
  - Valencia, Spanien, 46009
    - Hospital Universitario La Fe
- Asturias
  - Oviedo, Asturias, Spanien, 33007
    - Hospital Universitario Central de Asturias
- Barcelona
  - Badalona, Barcelona, Spanien, 08916
    - Hospital Universitario Germans Trias i Pujol
  - Hospitalet de Llobregat, Barcelona, Spanien, 08907
    - Hospital Universitario de Bellvitge
- Cantabria
  - Santander, Cantabria, Spanien, 39008
    - Hospital Universitario Marqués de Valdecilla
- Islas Baleares
  - Palma de Mallorca, Islas Baleares, Spanien, 07010
    - Hospital Son Espases
- La Coruña
  - Santiago de Compostela, La Coruña, Spanien, 15706
    - Complejo Hospitalario Universitario de Santiago
- Navarra
  - Pamplona, Navarra, Spanien, 31008
    - Clinica Universitaria de Navarra

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Adult kidney transplant recipients with chronic renal anemia.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: Kun etui
Tidsperspektiver: Tilbagevirkende kraft

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
The primary endpoint of the study is hemoglobin level variability Tidsramme: 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	the study includes the retrospective collection of information from the medical records of patients over a period of one year.

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Estimation of cardiovascular risk of patients Tidsramme: at the end of the study period (one year after the start of data recording)	according to the REGICOR function (acronym Girona Heart Registry)	at the end of the study period (one year after the start of data recording)
Potential factors influencing hemoglobin variability Tidsramme: 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.	Both baseline data and the changes recorded on the visit at month 12 will be considered.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sociedad Española de Trasplante

Efterforskere

Studiestol: Ana Sánchez Fructuoso, Coordinator, Hospital San Carlos, Madrid
Ledende efterforsker: Domingo Hernández, Md, Hospital Carlos Haya De Malaga
Ledende efterforsker: Teresa García, Md, Hospital Universitario Puerta del Mar
Ledende efterforsker: Ernesto Gómez Huertas, Md, Hospital Univ. Central de Asturias
Ledende efterforsker: Francisco Llamas Fuentes, Md, Complejo Hospitalario Univ. de Albacete
Studiestol: Juan Carlos Ruiz San Millán, Coordinator, Hospital Uni. Marqués de Valdecilla
Studiestol: Luis Guirado Perich, Coordinator, Fundación Puigvert
Ledende efterforsker: José Vicente Torregrosa, Md, Hospital Clinic of Barcelona
Ledende efterforsker: Francesc Moreso, Md, Hospital Univ. Vall d´Hebron
Ledende efterforsker: Ricardo Lauzurica Valdemoros, Md, Hospital Univ. Germans Trias I Pujol
Ledende efterforsker: María Luisa Mir Fontana, Md, Hospital del Mar
Ledende efterforsker: Alberto Martínez Castelao, Md, Hospital Univ. de Bellvitge
Ledende efterforsker: Rafael Romero Burgos, Md, Complejo Hospitalario Univ. De Santiago
Ledende efterforsker: Gonzalo Gómez, MD, Hospital Son Espases
Ledende efterforsker: Roberto Gallego Samper, Md, Hospital Univ. Dr. Negrín
Ledende efterforsker: Esther González Monte, Md, Hospital 12 de Octubre
Ledende efterforsker: Carlos Jiménez Martín, Md, Hospital Univ. La Paz
Ledende efterforsker: Manuel Rengel Aranda, Md, Hospital Univ. Gregorio Marañon
Ledende efterforsker: Carmen Bernis, Md., Hospital Univ. La Princesa
Ledende efterforsker: Pedro Errasti Goenaga, Md., Clinica Univ. de Navarra
Ledende efterforsker: Jaime Sánchez Plumed, Md, Hospital Univ. La Fe
Ledende efterforsker: Antonio Franco Esteve, Md, Hospital General Universitario de Alicante

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2012

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

19. december 2013

Først indsendt, der opfyldte QC-kriterier

17. januar 2014

Først opslået (Skøn)

20. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)