Trial record 13 of 106 for:    Open Studies | "Urine"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Hannover Medical School.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Wilfried Gwinner, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01315067
First received: March 14, 2011
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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.


Condition
Rejection of Renal Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Non-invasive Diagnosis of Acute Rejection in Renal Transplant Patients Using Mass Spectrometry of Urine Samples - a Multicentre Diagnostic Phase III Trial

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Ability of the urine mass spectrometry test to diagnose acute renal allograft rejection, compared to the gold standard 'allograft biopsy' [ Time Frame: Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Sensitivity and specificity of the urine test to diagnose acute renal allograft rejection in subgroups with different severity grades of the rejection [ Time Frame: Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day) ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day) ] [ Designated as safety issue: No ]
    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.

  • Sensitivity and specificity of the urine test to diagnose acute renal allograft rejection in subgroups with concurrent infection [ Time Frame: Results of the urine test will be assessed in relation to the simultaneously performed allograft biopsy (1 day) ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Urine samples, kidney allograft biopsies


Estimated Enrollment: 600
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315067

Contacts
Contact: Wilfried Gwinner, Prof./MD +49-511-532- ext 6320 gwinner.wilfried@mh-hannover.de

Locations
Germany
RTW University of Aachen Recruiting
Aachen, Germany, 52074
Contact: Anja Muehlfeld, MD    +49-241-8035652      
Contact: Astrid Kranz, Study Nurse       akranz@ukaachen.de   
Principal Investigator: Anja Mühlfeld, Dr. med.         
Sub-Investigator: Gisela Kroll, MD         
University of Erlangen-Nuremberg Recruiting
Erlangen, Germany, 90154
Contact: Yvonne Thoss, Study Nurse    +49-9131-8534149      
Principal Investigator: Michael Wiesener, MD         
Sub-Investigator: Karl Hilgers, MD         
Sub-Investigator: Roudolf Poliak, MD         
Sub-Investigator: Johannes Jacobi, MD         
Sub-Investigator: Sabine Jank, MD         
Sub-Investigator: Michaela Streubert, MD         
Universitätsklinikum Essen Recruiting
Essen, Germany, 45147
Contact: Felix Testroet, Study Nurse    +49-201 72383242      
Principal Investigator: Andreas Kribben, MD         
Sub-Investigator: Oliver Witzke, MD         
Sub-Investigator: Ulrike Wieneke, MD         
Sub-Investigator: Stefan Becker, MD         
Sub-Investigator: Thorsten Feldkamp, MD         
Sub-Investigator: Tobias Türk, MD         
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Zinaida Nabulsi, Study Nurse    +49-761-270-32710      
Principal Investigator: Gerd Walz, MD         
Sub-Investigator: Stefan Zschiedrich, MD         
Sub-Investigator: Marcel Geyer, MD         
Sub-Investigator: Daniel Steffl, MD         
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Elisabeth Bahlmann, Study Nurse    +49-511-532-3000      
Principal Investigator: Wilfried Gwinner, Prof./MD         
Sub-Investigator: Cristos Chatzikyrkou, MD         
Sub-Investigator: Armin Koch, Prof. Dr.         
Sub-Investigator: Antonia Zapf, Dr.         
Nephrologisches Zentrum Niedersachsen Not yet recruiting
Hannoversch-Münden, Germany, 34346
Contact: Peter Weithofer, MD    +49-5541-996-0      
Principal Investigator: Volker Kliem, MD         
Sub-Investigator: Peter Weithofer, MD         
Sub-Investigator: Alexander Nabokow, MD         
Universitätsklinikum Jena Recruiting
Jena, Germany, 07747
Contact: Christiane Rüster, MD    +49-3641-9324 ext 300      
Principal Investigator: Gunter Wolf, MD         
Sub-Investigator: Undine Ott, MD         
Sub-Investigator: Christiane Rüster, MD         
Universitätsklinikum Köln Not yet recruiting
Köln, Germany, 50937
Contact: Tülay Kisner, MD    +49-221 478 97630      
Principal Investigator: Thomas Benzing, MD         
Sub-Investigator: Tülay Kisner, MD         
Kliniken der Stadt Köln gGmbH Recruiting
Köln, Germany, 51109
Contact: Petra John, Study Nurse    +49-221-8907-0      
Principal Investigator: Wolfgang Arns, MD         
Sub-Investigator: Andrea Huppertz, MD         
Sub-Investigator: Katja Josefiak, MD         
Sub-Investigator: Benno Kitsche, MD         
Sub-Investigator: Robert Schuhmann, MD         
Ludwig-Maximilians-Universitätsklinik München Recruiting
München, Germany, 81377
Contact: S Gohr, Study Nurse    +49-89-70953961      
Principal Investigator: Michael Fischereder, MD         
Sub-Investigator: Antje Habicht, MD         
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Wilfried Gwinner, Prof. /MD Hannover Medical School
  More Information

Publications:
Responsible Party: Wilfried Gwinner, Prof. Dr. med., Hannover Medical School
ClinicalTrials.gov Identifier: NCT01315067     History of Changes
Other Study ID Numbers: MS-GW4/6-1
Study First Received: March 14, 2011
Last Updated: June 29, 2012
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Hannover Medical School:
kidney transplantation
acute rejection
diagnosis
urine analysis
urinary peptides
mass spectrometry
allograft biopsy
pathology
diagnostic study

ClinicalTrials.gov processed this record on October 22, 2014