Clinical Trial: Evaluation of a Predictive Immunovirological Test Occurrence of BK Virus Nephropathy in Renal Transplant

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of a Predictive Immunovirological Test Occurrence of BK Virus Nephropathy in Renal Transplant

Brief Summary:

Kidney transplantation is the treatment of choice for end stage renal disease (ESRD) improving the quantity and quality of life for dialysis patients. Although prolongation of graft survival in the short term by preventing the release is observed by immunosuppression (IS) powerful, the longer-term survival has not improved . Indeed, the IS can not only have a direct deleterious effect on the kidney transplant , but too weak IS can promote rejection, and too strong, promote the emergence of a viral disease polyomavirus BK ( BKV ) . BK nephropathy (BKVAN ) virus is accompanied by an irreversible impairment of the renal function , leading to a loss of the graft followed by a premature return to dialysis in at least 50 % of cases. Plasma BKV reactivation was observed mainly during the first year of transplantation in 15% of patients and complications annually BKVAN concern about 5 % of recipients . Currently , treatment options are very limited , only the decrease in IS shows a partially effective when care is early . There is no specific antiviral effective treatment of this disease . In addition, there is no way to predict which patients will develop BKV reactivation BKVAN despite lower tax.

The diagnosis of interstitial nephritis BKV based on the detection of viral DNA by PCR and plasma is confirmed by histological analysis of renal tissue . Plasma quantitative PCR ( qPCR) to measure the progression of the disease and therapeutic efficacy. Control of BKV viremia is the direct antiviral immune response quality based primarily on a very effective anti- T lymphocyte activity BKV reflection. In this context, the inhibition of lymphocyte activation induced by IS blocks the establishment of T-cell responses anti- BKV in most transplant, a very low presence of T lymphocytes is generally observed in these patients anti- BKV (LYT - BKV) blood .

Quantitative Measurement of BKV viral load decline after IS. Negativation sign healing, persistence is poor prognosis.



Original Primary Outcome: Same as current

Current Secondary Outcome: stability, decrease, increase of viremia [ Time Frame: 4 weeks, 8 weeks, 12 weeks, 6 months and 1 year ]

The evolution of viremia (stability, decrease, increase) profile may also be considered to analyze the immunological data obtained.


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nice

Dates:
Date Received: January 28, 2014
Date Started: February 2014
Date Completion: February 2016
Last Updated: August 31, 2015
Last Verified: August 2015