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

This study is currently recruiting participants.
Verified June 2012 by Hannover Medical School
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

March 14, 2011
June 29, 2012
October 2011
April 2013   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01315067 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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Diagnosis of Acute Rejection in Renal Transplant Patients by Urine Mass Spectrometry
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Urine samples, kidney allograft biopsies

Probability Sample

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

Rejection of Renal Transplant
Not Provided
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Wittke S, Haubitz M, Walden M, Rohde F, Schwarz A, Mengel M, Mischak H, Haller H, Gwinner W. Detection of acute tubulointerstitial rejection by proteomic analysis of urinary samples in renal transplant recipients. Am J Transplant. 2005 Oct;5(10):2479-88.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Wilfried Gwinner, Prof./MD +49-511-532- ext 6320 gwinner.wilfried@mh-hannover.de
Germany
 
NCT01315067
MS-GW4/6-1
Yes
Wilfried Gwinner, Hannover Medical School
Hannover Medical School
Not Provided
Principal Investigator: Wilfried Gwinner, Prof. /MD Hannover Medical School
Hannover Medical School
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP