Pre-formed Alloreactivity in Renal Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This investigator-initiated study will analyse the role of pre-formed alloreactive T cells on acute rejection episodes and graft outcome in kidney transplant recipients after living donation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Development of Antibodies Against Transplant Kidney After Infection

NCT06040684

Acute Infection Kidney Failure

COMPLETED

Study in Detection cfDNA for the Early-stage Diagnosis of Acute Rejection Post-renal Transplantation

NCT03759535

Kidney Transplant Failure and Rejection

UNKNOWN

Peripheral and Intrarenal B Cell Study in Antibody Mediated Transplant Rejection : Phenotypic and Transcriptional Study, Study of Reactivity

NCT07134491

Antibody Mediated Rejection After Kidney Transplantation

NOT_YET_RECRUITING

Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection

NCT05084768

Acute Rejection of Renal Transplant Graft Failure

RECRUITING

Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients

NCT06025240

Kidney Transplant Renal Transplant Failure Kidney Transplant Rejection +5 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In recipients of solid organ transplants, preformed alloreactive T cells may mediate acute rejections and compromise long-term graft survival. Previous studies on the role of alloreactive T cells in transplantation were hampered by the fact that experimental assays to quantify alloreactivity were technically demanding and not suitable for use in a clinical setting. Based on a recent development of a whole-blood assay, alloreactive T cells may be quantified and characterised within one day. This assay therefore provides the experimental basis to study the development and the role of alloreactive T cells in a clinical setting in patients after renal transplantation. This will be performed in a multicenter study in living donor renal transplant recipients where preformed alloreactivity of the recipient towards the living donor will be determined and associated with standard clinical parameters of graft function and long-term graft outcome on follow-up. In addition, the development of donor-specific antibodies will be analysed after transplantation. If this project was able to provide evidence for a role of alloreactive T cells in acute rejection episodes or long-term graft function, this assay may in future be used to guide individualized immunosuppressive drug treatment early after transplantation. It will thereby aid in distinguishing patients where standard immunosuppressive drug regimens are sufficient from the minor population of patients at high risk for rejection who will benefit from intensified drug regimens.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Transplantation Acute Graft Rejection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

kidney transplant recipients

kidney transplant recipients of an allograft from a living donor, no intervention

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Written informed consent
* First or second renal transplantation
* Living donor renal transplantation
* Recipient older than 18 years
* Negative cross match
* Planed quadruple, Tacrolimus-based (low-dose) immunosuppressive drug regimen (Tacrolimus, 2g MMF starting dose, (methyl)prednisolone according to center practice, basiliximab at day 0 and day 4)
* Planned start of Tacrolimus (Advagraf®) 3 to 10 days prior to transplantation (trough levels 5-10 ng/ml during the first 3 months, 5-7 ng/ml thereafter)

Exclusion Criteria

* Planed T-cell depleting induction therapy
* Pregnancy
* Pre-existing, moderate to high dose immunosuppressive medication
* Pre-existing, severe lymphopenia (\&lt; 400/µl)

Eligible Sex

ALL

Accepts Healthy Volunteers

No