Functional Non Specific Immunity Monitoring After Kidney Transplantation Using an Interferon Gamma Test

NCT03572842 | Completed

• 1 other identifier: 18-AOI-04
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

The best renal replacement therapy is kidney transplantation. It improves end-stage renal kidney disease (ESRD) patients quality of life and increases their survival, but still remains risky. Morbidity in kidney transplantation is dominated by two main complications : acute graft rejection and infections. To maintain an accurate balance between rejection and infection, immunosuppressive therapy must to be used with caution and kept into a tight spectrum. The investigators dispose of a new test measuring interferon gamma production after T cells and Natural Killers (NK) in vitro stimulation : QuantiFERON Monitor® (QFM). They hypothesized QFM monitoring could improve management after kidney transplantation providing functional immune data to optimize balance between rejection and infection. The investigators aim to assess whether QFM could be an objective biomarker to predict infection and rejection risks after kidney transplantation.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Change of QuantiFERON Monitor® levels (interferon gamma, UI/mL)

  QuantiFERON Monitor® levels (interferon gamma, UI/mL)

  At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation

Secondary Outcomes (3)

• Acute cellular and/or antibodies mediated graft rejection

  At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation

• Infections

  At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation

• Lymphocytes sub-populations

  At day 0 (inclusion), Between Day 7 and Day 21 (before discharge), 3 month post-transplantation, 6 month post-transplantation

Study Arms (1)

quantiferon monitor

OTHER

Test measuring interferon gamma production after T cells and Natural Killers (NK) in vitro stimulation : QuantiFERON Monitor® (QFM)

Other: quantiferon monitor test

Interventions

quantiferon monitor test OTHER

different blood test with quantiferon monitor

quantiferon monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Free and informed consent
• Age \> 18 years-old

You may not qualify if:

• Current infection
• Vulnerable people (minors, guardianship or curatorship, pregnant women, deprivation of liberty, person who does not speak French)
• Non-affiliated person with Social Security
• Transplantectomy before sixth month

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nephrology Department, Nice University Hospital

Nice, 06000, France

Location

Study Officials

• Barbara SEITZ-POLSKI, Dr

  Nephrology Department, Nice University Hospital

  STUDY CHAIR

• Marion CREMONI GAUCI

  Nephrology Department, Nice University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 28, 2018
• Study Start: January 24, 2019
• Primary Completion: January 24, 2021
• Study Completion: October 11, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)