Assessment of microvascular alterations using orthogonal spectral polarization and correlate this with markers for endothelial cell dysfunction, fibrosis and histology in patients with renal function impairment who will undergo renal biopsy and…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Non- invasive assessment of microvascular structure using OPS in patients
with and without rejection
Secondary outcome
1. Correlation of microvascular alterations and markers for endothelial
dysfunction, fibrosis and histology
2. Correlation of microvascular alterations and renal function
3. Correlation of microvascular alterations and graft survival
Background summary
Renal transplantation is the preferred treatment for end-stage kidney failure
as it delivers superior patient survival and quality of life compared with
dialysis. There have been significant improvements in rates of renal transplant
rejection over the last two decades, giving 1-year graft survival rates of over
95%. However this reduction in rejection has not translated into improvements
in long-term graft survival. Chronic allograft nephropathy (CAN) and rejection
are the most common cause of late transplant failure. In the pathogenesis of
CAN and rejection irreversible injury and loss of peritubular capillaries (
PTCs) play an important role in the development of graft function deterioration
and progressive interstitial fibrosis. The microvasculature of transplanted
organs plays an important role in post-transplant graft failure, because of the
interaction between inflammatory cells with the microvascular endothelial cell
lining during ischemia-reperfusion injury and graft rejection. Since
microvasculature endothelial cell injury is associated with graft dysfunction,
tubulointerstitial injury and renal fibrosis, measurements enabling early
recognition of factors contributing to graft failure may improve outcomes after
kidney transplantation. Studies using OPS during kidney and liver
transplantation, demonstrated early microvascular changes following
ischemia-reperfusion injury and rejection and a correlation with clinical
markers. This indicates a possible therapeutic implication of OPS imaging to
predict microvascular alterations in organ transplantation which represents
major determinants of graft dysfunction and destruction
Study objective
Assessment of microvascular alterations using orthogonal spectral polarization
and correlate this with markers for endothelial cell dysfunction, fibrosis and
histology in patients with renal function impairment who will undergo renal
biopsy and compare patients with and without rejection/ CAN .
Study design
The study is designed as a prospective observational study. Patients will be
included if the have renal impairment after transplantation and had a biopsy
for clinical reason with the suspicion of rejection/ CAN. As a control we will
include patients with stable renal function after transplantation and healthy
controls to compare the OPS measurement en the markers for fibrosis and
endothelial dysfunction.
Study burden and risks
Study visits for the renal transplant patients will be planned at outpatient
follow-up controls. The visits will take 1hour extra for the OPS measurement.
For the healthy controls the visits will take 1,5 hour extra for the OPS
measurement, blood and urine samples.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for renal transplant patients:
1. Age: 18 -70 years
2. Female or male
3. Kidney transplantation( living and cadaveric)
4. Patients who will undergo renal biopsy because of renal function impairment
5. Patients must be able to adhere to the study visit schedule and protocol requirements.
6. Patients must be able to give informed consent and the consent must be obtained prior to any study procedure.;Inclusion criteria for healthy controls:
1. Age: 18-70
2. Female or male
Exclusion criteria
Exclusion criteria for renal transplant patients:
1. Double organ transplantation
2. Patients with evidence of active infection or abcesses.
3. Patients suffering from hepatic failure.
4. Patients suffering from an active autoimmune disease
5. Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence)
6. Patients who currently have an active opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB)
7. Patients with epilepsy;Exclusion criteria for healthy controls:
1. Smoking (within 1 year prior to screening)
2. History of cardiovascular disease
3. History of malignancy
4. Use of any investigational agent in the last 30 days
5. History of chronic inflammatory disease
6. History of chronic skin diseases
7. History of diabetes mellitus
8. History of alcohol or drug abuse within the last 5 years
9. Hypertension
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29142.058.09 |