Hôpital Henri Mondor
Créteil, 94000, France
Location status: Recruiting
Location contact
Marie Dr MATIGNON, MD, PhD
CONTACT
Vincent Pr AUDARD, MD, PhD
CONTACT
NCT Number: NCT06810258
In clinical nephrology, the search for urinary, blood and tissue biomarkers of specific kidney diseases is an important goal. In recent years, the use of these biomarkers has made it possible to diagnose many renal diseases that affect the native kidney. In some cases, biomarkers may be useful in determining the evolutionary profile of the disease and thus the most appropriate therapeutic management.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Créteil, 94000, France
Location status: Recruiting
Marie Dr MATIGNON, MD, PhD
CONTACT
Vincent Pr AUDARD, MD, PhD
CONTACT
In clinical nephrology, the search for urinary, blood and tissue biomarkers of specific kidney diseases is an important goal. In recent years, the use of these biomarkers has made it possible to diagnose many renal diseases that affect the native kidney. In some cases, biomarkers may be useful in determining the evolutionary profile of the disease and thus the most appropriate therapeutic management.
The progression of these kidney diseases sometimes necessitates kidney transplantation for patients undergoing follow-up. Although the one-year survival rate for kidney transplantation has improved significantly over the last decade and is currently 90%, long-term survival is not increasing. Renal graft biopsy remains the reference method for the diagnosis and prognosis of various post-transplant conditions. This method has two limitations: i) it is an invasive procedure associated with complications, which means that it cannot be performed systematically on a large scale throughout the transplant process; ii) the sample size is limited and does not always allow a reliable prognosis to be made. The identification of urinary or blood biomarkers with diagnostic and prognostic value would allow an earlier diagnosis than that made by kidney biopsy. This would allow patients to be treated specifically and individually at an early stage, before damage to the kidney graft occurs, and would significantly improve long-term kidney graft survival.
The main objective of this study is to investigate blood, urine and tissue biomarkers in renal pathologies for diagnostic and prognostic purposes.
As this is an observational study, the main criteria of interest for analysis will include
Once the patient has been informed and has consented to participate in the study, and once the selection criteria have been verified:
For patients undergoing native renal biopsy:
A single blood and urine sample (17.5 ml blood: serum, PBMC, RNA) will be collected on the day of the renal biopsy.
In kidney transplant patients:
On the day of the kidney biopsy, patients will be admitted to the day hospital. An additional blood sample (17.5 ml blood: serum, PBMC, RNA) will be taken for each kidney biopsy performed as part of standard care. A urine sample (one to two 50 mL urine tube) is collected.
These blood, urine and tissue samples may be stored in a biological collection and used for constitutional genetic studies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
blood sample during standard of care visit for a native kidney biopsy (17.5mL)
blood sample during standard of care visit for a renal graft biopsy (17.5mL)
Urine sample during standard of care visit for a renal graft biopsy (50mL)
Urine sample during standard of care visit for a native kidney biopsy (50mL)
Time frame: 1 year
the main criteria of interest for the analysis will include :
Time frame: through study completion, an average of 1 year
These samples may also be used to conduct studies aimed at enhancing the understanding of: the pathophysiological mechanisms involved in the development of native kidney diseases (e.g., acute cellular or humoral rejection, chronic graft dysfunction, BK virus nephropathy, etc.), and factors predictive of tolerance and response to treatment, which could lead to the identification of new therapeutic biomarkers and therapeutic targets.
The choice of markers is still highly exploratory, but we would mention: CXCL10, CXCL9, FoxP3, Vimentin
Contact information is provided by the study sponsor or research team.
Marie Dr MATIGNON, MD, PhD
CONTACT
Vincent Pr AUDARD, MD, PhD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Diagnostic and PROgnostic BIOmarkers Before and After Kidney Transplantation
Acronym: PROBIOT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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