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Diagnosis of Acute Rejection in Renal Transplant Patients by Urine Mass Spectrometry

9 août 2017 mis à jour par: Wilfried Gwinner, Hannover Medical School

Non-invasive Diagnosis of Acute Rejection in Renal Transplant Patients Using Mass Spectrometry of Urine Samples - a Multicentre Diagnostic Phase III Trial

Reliable and timely detection of acute rejections in renal transplant patients is important to preserve the graft function and to prevent premature graft failure. The current gold standard for the rejection diagnosis is a renal biopsy which is usually performed upon an unexplained decline in the graft function (determined by serum creatinine or clearance). Because of the insensitivity of creatinine determinations and the invasiveness of renal biopsies, non-invasive tests have been suggested to diagnose acute rejection including mass spectrometry (MS) analysis of urine samples.

The ability of MS analysis to detect acute rejection has been demonstrated in small studies on selected patients but evidence is lacking that this test is efficacious in the routine setting of the post-transplant patient care. Based on our previous work that established urine peptide sets for acute rejection by MS, a prospective, multicentre diagnostic phase III study will be executed.

The aim of the study is to prove that this test is as equally effective as the allograft biopsy to detect acute rejection in patients that undergo a biopsy for unexplained renal dysfunction. The perspective of this approach is that the test could be used either in place of the biopsy or as decision guidance whether a biopsy is necessary to confirm the presence of rejection. Another perspective is that the MS test (respectively, a simplified test system derived from this method) could be used in the regular post-transplant surveillance for acute rejection, in place of the relatively insensitive procedure with periodic monitoring of the graft function by creatinine determinations.

Aperçu de l'étude

Statut

Complété

Les conditions

Rejet de greffe rénale

Type d'étude

Observationnel

Inscription (Réel)

600

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Allemagne
- - Aachen, Allemagne, 52074
    - RTW University of Aachen
  - Berlin, Allemagne, 10117
    - Charité Universitätsmedizin Berlin
  - Erlangen, Allemagne, 90154
    - University of Erlangen-Nuremberg
  - Essen, Allemagne, 45147
    - Universitätsklinikum Essen
  - Hannover, Allemagne, 30625
    - Hannover Medical School
  - Jena, Allemagne, 07747
    - Universitatsklinikum Jena
  - Köln, Allemagne, 51109
    - Kliniken der Stadt Koln gGmbH
  - München, Allemagne, 81377
    - Ludwig-Maximilians-Universitätsklinik München

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Patients with a kidney or combined kidney/pancreas transplantation from several German transplant centres with an acute unexplained allograft dysfunction within the first year of transplantation who require a clinically indicated allograft biopsy

La description

Inclusion Criteria:

Adult patients with a kidney or combined kidney/pancreas transplantation
Unexplained renal allograft dysfunction within the first year of transplantation
Renal allograft biopsy, which is clinically indicated to verify or exclude an acute rejection

Exclusion Criteria:

Lacking consent of the patient to participate in the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Ability of the urine mass spectrometry test to diagnose acute renal allograft rejection, compared to the gold standard 'allograft biopsy' Délai: Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day)	In patients with unexplained renal allograft dysfunction who get an allograft biopsy to clarify if an acute rejection is present, a simultaneous urine sample will be taken. The peptide pattern of this urine sample is analyzed by mass spectrometry and a diagnosis is made (rejection present/not present) based on a pre-defined peptide pattern which was established to detect acute allograft rejection. In the primary outcome analysis, the sensitivity and specificity of the rejection diagnosis by the urine test is compared to the diagnosis made by the allograft biopsy.	Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day)

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Sensitivity and specificity of the urine test to diagnose acute renal allograft rejection in subgroups with different severity grades of the rejection Délai: Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day)	Sensitivity/specificity measures for the urine test will be determined in subgroups of patients with different severity of the rejection. Severity grading is based on the pathomorphological classification of the rejection (according to the BANFF classification) and on the functional impairment of the allograft at the time of rejection diagnosis.	Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day)
Sensitivity and specificity of the urine test to diagnose acute renal allograft rejection in subgroups with kidney transplantation alone and with combined pancreas/kidney transplantation Délai: Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day)	Sensitivity/specificity measures for the urine test will be determined in subgroups of patients who have a kidney transplant or a combined pancreas/kidney transplant.	Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day)
Sensitivity and specificity of the urine test to diagnose acute renal allograft rejection in subgroups with concurrent infection Délai: Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day)	Sensitivity/specificity measures for the urine test will be determined in subgroups of patients who have concurrent infections at the time of the biopsy and urine sampling such as cytomegaly virus, polyoma virus, and urinary tract infection. The analysis intends to identify potential interference of these conditions with the urine mass spectrometry test.	Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hannover Medical School

Les enquêteurs

Chercheur principal: Wilfried Gwinner, Prof. /MD, Hannover Medical School

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2011

Achèvement primaire (Réel)

1 mars 2017

Achèvement de l'étude (Réel)

15 juin 2017

Dates d'inscription aux études

Première soumission

14 mars 2011

Première soumission répondant aux critères de contrôle qualité