Overview

This trial is active, not recruiting.

Condition rejection of renal transplant
Sponsor Hannover Medical School
Start date October 2011
End date October 2016
Trial size 600 participants
Trial identifier NCT01315067, MS-GW4/6-1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional

Primary Outcomes

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)

Secondary Outcomes

Measure
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)
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)
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)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Non-invasive Diagnosis of Acute Rejection in Renal Transplant Patients Using Mass Spectrometry of Urine Samples - a Multicentre Diagnostic Phase III Trial
Principal investigator Wilfried Gwinner, Prof. /MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hannover Medical School.