To investigate whether it is possible to indicate (focal) IF/TA lesions in renal allografts with MRI and compare these findings to the extent of IF/TA in the kidney biopsy that has been taken previously according to current clinical guidelines.
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint will be the degree of functional allograft damage.
Differences between values of various MRI parameters (see *5.2 Study
Procedures*) obtained in transplantation patients with and without chronic
allograft dysfunction on the one hand, and between transplantation patients and
healthy (control) volunteers on the other hand, will be analyzed.
Secondary outcome
The secondary endpoint will be the degree of structural allograft damage. This
degree will be determined by analyzing the correlation between the best
parameter (or combination of parameters) and the degree of IF/TA that was
diagnosed in patients included in group A.
Reproducibility of the scan protocol in patients.
Background summary
A major group of kidney transplantation patients suffers from chronic allograft
dysfunction (CAD) within ten years after transplantation. Several conditions
can cause CAD (e.g. chronic immunologic response, BK-virus, drug toxicity).
Currently, histologic biopsy is the gold standard for diagnosing allograft
damage interstitial fibrosis and tubular atrophy (IF/TA) due to CAD. The
lesions that become visible in renal biopsies are referred to as *interstitial
fibrosis and tubular atrophy* (IF/TA). However, obtaining renal tissue for
histology is associated with several disadvantages, including sampling error
(resulting in incorrect disease management) and allograft bleeding or
infection. In addition, delayed diagnosis of CAD may lead to allograft loss,
and since there is a substantial shortage of organ donors, prolonged allograft
survival is of great importance. In conclusion, there is an unmet need for
additional diagnostic tools that can be of supportive value in the diagnostic
process of CAD. For this, we would like to use MRI (Magnetic resonance imaging)
as a novel diagnostic tool to visualize areas of IF/TA in CAD. To our
knowledge, a comparison between findings on MRI-images and the degree of IF/TA
in the kidney biopsy has not been studied before.
Study objective
To investigate whether it is possible to indicate (focal) IF/TA lesions in
renal allografts with MRI and compare these findings to the extent of IF/TA in
the kidney biopsy that has been taken previously according to current clinical
guidelines.
Study design
Pilot study in 50 volunteers.
Study burden and risks
There are no known risks or adverse effects to MRI, beside dizziness and
claustrophobia. The burden for subjects is relatively low in this study, and no
contrast is needed. A risk for subjects may be the finding of an unexpected
abnormality. When an unexpected abnormality is found, the volunteer and their
general practitioner will be informed . In case of a patient their treating
specialist will be informed. Because the studied MRI method is no standardized
practice, the nature of the abnormality cannot be established with any
certainty. To inform the volunteer or patient and their physicians, a letter
will be written to explain the finding and to suggest the needed follow up.
There are no direct benefits for the subject. The aim of this study is to
develop a new diagnostic tool for renal allograft assessment that is more
accurate in an early stage of disease and less invasive than the current gold
standard. Therefore addition of renal MRI scanning to existing diagnostic tools
can be an improvement for diagnosis of CAD.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Group A (n=15):
Patients have undergone at least one kidney transplantation procedure;Patients are 18 year or older;Patients are currently suspect for CAD at the time of inclusion (CAD is defined as a clinical diagnosis characterized by deterioration of kidney function in any way (e.g. increase in SCr, new proteinuria) that demands further diagnostic evaluation; Kidney biopsy is performed according to the existing guidelines for clinical practice just prior to or shortly after the MRI-scan has been performed (time in between the events < 2 weeks) ;Time between NTx and inclusion must be at least 6 months,Patients volunteer to participate and are capable and prepared to sign an informed consent.;Group B (n=20):
Volunteers have undergone at least one kidney transplantation procedure; Volunteers are 18 year or older; volunteers have a well-functioning allograft and are not showing any clinical signs of allograft dysfunction; Time between NTx and inclusion is at least 3 months; Volunteers are capable and prepared to sign an informed consent;Group C1 (n=15 - x):
Volunteers have donated a kidney to someone that is included in group A or B; Volunteers are 18 year or older; Volunteers are not altruistic kidney donor; Volunteers are not diagnosed with any renal disease; Volunteers are prepared to give a blood sample for analysis of the SCr; Volunteers are capable and prepared to sign an informed consent.;Group C2 (n=x):
Volunteers are 18 year or older; Volunteers are not diagnosed with any renal disease; Volunteers are prepared to give a blood sample for analysis of the SCr; Volunteers are capable and prepared to sign an informed consent; Volunteers can be sex- and age matched within a range of 5 years to patients in group A/B1 (who are not already matched to their donor). Part of the volunteer data will consist of data from volunteers who are already scanned for another study (ReMARK, METC NL45144.041.13, 13/402) under the same conditions with the same scan protocol.
Exclusion criteria
Volunteers with contra-indications for MRI (like a pacemaker, an internal prosthesis or claustrophobia); Refusal of volunteers to be informed of chance findings possibly relevant to their health; Pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL53885.041.15 |
| OMON | NL-OMON26023 |