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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03227965

Enrollment

Registered

2017-07-24

Start date

2017-01-13

Completion date

2019-02-07

Last updated

2019-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant; Complications

Keywords

cancer

Brief 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.

Interventions

BIOLOGICALImmune cells population assesment

T lymphocytes population description through blood, urine and faeces samples

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Immune cells study	12 months	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

Secondary

Measure	Time frame	Description
bacteria study	12 months	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
cancer incidence	12 months	Assess cancer incidence, on a population of people with kidney transplantation (since 10 years) : observation of adverse events during visits

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026