Kidney transplantation i Nyreanemi - Klinisk prøveregister

Studieoversikt

Status

Fullført

Forhold

Nyreanemi

Intervensjon / Behandling

Fremgangsmåte: kidney transplantation

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

368

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Bare etui
Tidsperspektiver: Retrospektiv

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sociedad Española de Trasplante

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2012

Primær fullføring (Faktiske)

1. oktober 2012

Studiet fullført (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først innsendt

19. desember 2013

Først innsendt som oppfylte QC-kriteriene

17. januar 2014

Først lagt ut (Anslag)

20. januar 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)