Immunosuppression's Long Term Impact on Anti-tumoral Oversight in Kidney Transplantation

Kidney Transplant; Complications Clinical Trial

Official title:

Immunosuppression's Long Term Impact on Anti-tumoral Oversight in Kidney Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03227965
• Other study ID #: ELITE
• Status: Completed
• Phase: N/A
• Start date: January 13, 2017
• Est. completion date: February 7, 2019

Study information

• Verified date: April 2019
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cancer is a well known complication about long term transplantation. Cancer outcomes are due to the immunosuppressive treatment that prevents transplanted people from rejection. By lowering the effectiveness of the immune system, immune cells are no longer able to seek and destroy cancer cells.

The goal here is to study immunes cells population of people that were transplanted 10 years ago and are now treated either by a corticosteroid - azathioprine association, or only by cyclosporine A.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 7, 2019
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18

• Patients with kidney transplantation for 10 year

• Patients with stable renal function (less than 20% creatinine variation during the last 12 months)

• Patients treated either by a corticosteroid - azathioprine association or cyclosporine A

• Patients giving his agreement

• Patients legally free

Exclusion Criteria:

• Patients under 18

• Patients under legal protection

• Pregnant women, or of age to get pregnant

Related Conditions & MeSH terms

• Kidney Transplant; Complications

Intervention

Biological:
• Immune cells population assesment
T lymphocytes population description through blood, urine and faeces samples

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune cells study	Study 2 types of T lymphocytes (by flow cytometry) that are suspected to be responsible of the graft non rejection and the cancer outcome, treated by corticosteroid - azathioprine association or cyclosporine A	12 months
Secondary	bacteria study	Study the modification of the intestinal bacteria population that might led to an "operational tolerance", depending on the immunosuppressive treatment : the DNA will be extracted from the faeces and a typing will be carried out by Polymerase Chain Reaction	12 months
Secondary	cancer incidence	Assess cancer incidence, on a population of people with kidney transplantation (since 10 years) : observation of adverse events during visits	12 months