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Prospective Donor Specific T Response Measurment for IS Minimization in de Novo Renal Transplantation

Disorder Related to Renal Transplantation Clinical Trial

Official title:
Prospective Donor-specific Cellular Alloresponse Assessment for Immunosuppression Minimization in de Novo Renal Transplantation

Clinical Trial Summary

The main objective of the study is to demonstrate the utility and safety of the IFN-γ (Interferon Gamma) ELISPOT (Enzyme-linked immunosorbent spot) marker for the stratification of kidney transplant recipients into low and high IS (Immunosuppression) regimens. The enrichment study will test non-inferiority of low IS regimen compared to high IS regimen, assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit of maximum 10%.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Disorder Related to Renal Transplantation
  • Effects of Immunosuppressant Therapy
Clinical Trial Details
NCT number NCT02540395
Study type Interventional
Source Charite University, Berlin, Germany
Contact
Status Completed
Phase N/A
Start date March 2015
Completion date October 31, 2020
View Details
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