scholarly journals A Prospective Multicenter Trial to Evaluate Urinary Metabolomics for Non-invasive Detection of Renal Allograft Rejection (PARASOL): Study Protocol and Patient Recruitment

2022 ◽  
Vol 8 ◽  
Author(s):  
Miriam C. Banas ◽  
Georg A. Böhmig ◽  
Ondrej Viklicky ◽  
Lionel P. Rostaing ◽  
Thomas Jouve ◽  
...  
Keyword(s):  
Allograft Rejection ◽  
Renal Allograft ◽  
Urine Samples ◽  
Control Group ◽  
Case Group ◽  
Transplant Recipients ◽  
Renal Allograft Rejection ◽  
Non Invasive ◽  
Additional Group ◽  
Over Time

Background: In an earlier monocentric study, we have developed a novel non-invasive test system for the prediction of renal allograft rejection, based on the detection of a specific urine metabolite constellation. To further validate our results in a large real-world patient cohort, we designed a multicentric observational prospective study (PARASOL) including six independent European transplant centers. This article describes the study protocol and characteristics of recruited better patients as subjects.Methods: Within the PARASOL study, urine samples were taken from renal transplant recipients when kidney biopsies were performed. According to the Banff classification, urine samples were assigned to a case group (renal allograft rejection), a control group (normal renal histology), or an additional group (kidney damage other than rejection).Results: Between June 2017 and March 2020, 972 transplant recipients were included in the trial (1,230 urine samples and matched biopsies, respectively). Overall, 237 samples (19.3%) were assigned to the case group, 541 (44.0%) to the control group, and 452 (36.7%) samples to the additional group. About 65.9% were obtained from male patients, the mean age of transplant recipients participating in the study was 53.7 ± 13.8 years. The most frequently used immunosuppressive drugs were tacrolimus (92.8%), mycophenolate mofetil (88.0%), and steroids (79.3%). Antihypertensives and antidiabetics were used in 88.0 and 27.4% of the patients, respectively. Approximately 20.9% of patients showed the presence of circulating donor-specific anti-HLA IgG antibodies at time of biopsy. Most of the samples (51.1%) were collected within the first 6 months after transplantation, 48.0% were protocol biopsies, followed by event-driven (43.6%), and follow-up biopsies (8.5%). Over time the proportion of biopsies classified into the categories Banff 4 (T-cell-mediated rejection [TCMR]) and Banff 1 (normal tissue) decreased whereas Banff 2 (antibody-mediated rejection [ABMR]) and Banff 5I (mild interstitial fibrosis and tubular atrophy) increased to 84.2 and 74.5%, respectively, after 4 years post transplantation. Patients with rejection showed worse kidney function than patients without rejection.Conclusion: The clinical characteristics of subjects recruited indicate a patient cohort typical for routine renal transplantation all over Europe. A typical shift from T-cellular early rejections episodes to later antibody mediated allograft damage over time after renal transplantation further strengthens the usefulness of our cohort for the evaluation of novel biomarkers for allograft damage.

Non-Invasive Diagnostic of Renal Allograft Rejection Via Urine Metabolites Using NMR-spectroscopy

2018 ◽  
Vol 102 ◽  
pp. S27
Author(s):  
Miriam Banas ◽  
Sindy Neumann ◽  
Philipp Pagel ◽  
Eric Schiffer ◽  
Dominik Chittka ◽  
...  
Keyword(s):  
Nmr Spectroscopy ◽  
Allograft Rejection ◽  
Renal Allograft ◽  
Urine Metabolites ◽  
Renal Allograft Rejection ◽  
Non Invasive

Non-invasive immune monitoring of perforin/granzyme B in peripheral blood may predict renal allograft rejection

2003 ◽  
Vol 64 (10) ◽  
pp. S32 ◽  
Author(s):  
Leonard W. Liang ◽  
Qiuheng Zhang ◽  
David Gjertson ◽  
H.Albin Gritsch ◽  
Elaine F. Reed
Keyword(s):  
Peripheral Blood ◽  
Allograft Rejection ◽  
Renal Allograft ◽  
Granzyme B ◽  
Immune Monitoring ◽  
Renal Allograft Rejection ◽  
Non Invasive

scholarly journals Comparison of clinical outcome of induction immunosuppressive therapy with thymoglobulin and standard therapy in kidney transplantation; a randomized double-blind clinical trial

2019 ◽  
Vol 9 (1) ◽  
pp. e08-e08
Author(s):  
Heshmatollah Shahbazian ◽  
Ali Ghorbani ◽  
Fatemeh Hayati ◽  
Seyed Seifollah Beladi Mousavi ◽  
Leila Sabetnia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kidney Transplantation ◽  
Kidney Transplant ◽  
Induction Therapy ◽  
Allograft Rejection ◽  
Control Group ◽  
Case Group ◽  
Transplant Recipients ◽  
Acute Allograft Rejection ◽  
Kidney Transplant Recipients

Introduction: Thymoglobulin is a lymphocyte-depleting polyclonal antibody, administered for induction therapy at the time of kidney transplantation to reduce the risk of acute allograft rejection. The appropriate dosage and duration of therapy is controversial. The higher dosages are associated with infection and malignancy. Objectives: In this study efficacy and safety of lower dosage (in comparison with previous studies) of thymoglobulin in kidney transplant recipients was evaluated. Patients and Methods: In this clinical trial, 106 adult kidney transplant recipients, were randomized before transplantation in two groups (case and control). The case group (53 patients) were received induction therapy with thymoglobulin (1.5 mg/kg/d for 3 days) and the control group (53 patients) were received non-induction regiment. Delayed graft function (DGF), glomerular filtration rate (GFR), acute allograft rejection and thymoglobulin complications were evaluated during the first post-transplantation year. Results: Around 106 kidney transplant recipients were enrolled (71 or 66.98% deceased donor) to the study. No significant statistical differences were found in GFR at the time of discharge from hospital (P=0.399) and at 1 year (P=0.851) and acute allograft rejection (P= 0.304) between two groups. Graft survival (73.5% in case group versus 81.1% in control group, P=0.392) at month 12th was similar among groups. Additionally, no significant differences of acute allograft rejection in recipient from deceased or living donor between two groups were detected. There was a higher incidence of DGF in the control group (26.4%) than the thymoglobulin group (5.8%) and the difference was statistically significant (P= 0.004). Thrombocytopenia (17% versus 49.1%, P<0.001) and leukopenia (11.3% versus 50.9%, P<0.001) were also significantly higher in the case group. Conclusion: While the incidence of DGF was reduced in thymoglobulin group, the short-term acute allograft rejection rate was not reduced compared to the control group. However, our results require further consideration with larger samples

1947: Non-Invasive Immune Monitoring of Perforin/Granzyme B in Serum May Predict Renal Allograft Rejection

2004 ◽  
Vol 171 (4S) ◽  
pp. 514-514
Author(s):  
Leonard W. Liang ◽  
Qiuheng Zhang ◽  
David Gjertson ◽  
Elaine Reed ◽  
H. Albin Gritsch
Keyword(s):  
Allograft Rejection ◽  
Renal Allograft ◽  
Granzyme B ◽  
Immune Monitoring ◽  
Renal Allograft Rejection ◽  
Non Invasive

scholarly journals Determinants of Hypofiltration during Acute Renal Allograft Rejection

2002 ◽  
Vol 13 (3) ◽  
pp. 773-778
Author(s):  
Alkesh Jani ◽  
Catherine Polhemus ◽  
Geraldine Corrigan ◽  
Osun Kwon ◽  
Bryan D. Myers ◽  
...  
Keyword(s):  
Acute Rejection ◽  
Morphometric Analysis ◽  
Allograft Rejection ◽  
Renal Allograft ◽  
Control Group ◽  
Hydraulic Pressure ◽  
Acid Extraction ◽  
Oncotic Pressure ◽  
Renal Allograft Rejection ◽  
Acute Renal Allograft Rejection

ABSTRACT. This study sought to determine the extent to which GFR is decreased during acute renal allograft rejection in human subjects and to determine the mechanism of the decrease in GFR. Eight patients with biopsy-proven acute rejection were compared with 18 recipients of optimally functioning renal allografts. GFR and renal plasma flow (RPF) were measured as the clearance of inulin and para-aminohippuric acid, respectively. Arterial BP was determined, blood was sampled, and plasma oncotic pressure (πA) was measured. Glomeruli obtained by biopsy during rejection were subjected to morphometric analysis, for determination of Kf. Control morphometric values for healthy glomeruli were provided by 10 living donors from whom biopsies were obtained at the time of organ donation. The subjects in the acute rejection group exhibited a significantly reduced GFR of 17 ± 4 ml/min per 1.73 m2, compared with 72 ± 4 ml/min per 1.73 m2 for control subjects (P < 0.001). With the use of a sensitivity analysis to take into account the unknown para-aminohippuric acid extraction ratio, the RPF rate was calculated to have likely been significantly decreased, by 45 to 70%, in the acute rejection group. Neither the plasma oncotic pressure nor the mean arterial pressure differed between the two groups. Morphometric analysis revealed no difference in the single-nephron Kf values for the acute rejection group, compared with the control group. These results indicate that acute renal allograft rejection causes a profound decrease in GFR, which is attributable to a decrease in RPF alone or in combination with a decrease in the glomerular transcapillary hydraulic pressure gradient (ΔP).

scholarly journals Non-Invasive Imaging of Acute Renal Allograft Rejection in Rats Using Small Animal 18F-FDG-PET

PLoS ONE ◽  
2009 ◽  
Vol 4 (4) ◽  
pp. e5296 ◽  
Author(s):  
Stefan Reuter ◽  
Uta Schnöckel ◽  
Rita Schröter ◽  
Otmar Schober ◽  
Hermann Pavenstädt ◽  
...  
Keyword(s):  
Allograft Rejection ◽  
Fdg Pet ◽  
Renal Allograft ◽  
Small Animal ◽  
Renal Allograft Rejection ◽  
Non Invasive ◽  
Acute Renal Allograft Rejection ◽  
18F Fdg
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