Pre-formed Alloreactivity in Renal Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02633826
Recruitment Status : Unknown
Verified January 2017 by Martina Sester, Saarland University.
Recruitment status was:  Recruiting
First Posted : December 17, 2015
Last Update Posted : January 23, 2017
Information provided by (Responsible Party):
Martina Sester, Saarland University

Brief Summary:
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.

Condition or disease
Kidney Transplantation Acute Graft Rejection

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Pre-formed Alloreactive T Cells on Acute Rejection Episodes and Long-term Graft Outcome in Patients After Living Donor Renal Transplantation
Study Start Date : November 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. graft function [ Time Frame: 1 year ]
    1-year graft function (estimated glomerular filtration rate)

Secondary Outcome Measures :
  1. Creatinine [ Time Frame: 1 year ]
    1-year creatinine

  2. Cystatin C [ Time Frame: 1 year ]
    1-year cystatin C

  3. rejection: acute rejection episodes within the first year [ Time Frame: 1 year ]
  4. proteinuria within the first year [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Transplant recipients of a kidney from a living donor

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 (< 400/µl)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02633826

Contact: Martina Sester, PhD 0049-6841-16 ext 23557
Contact: Urban Sester, MD 0049-6841-16 ext 23541

Saarland University Recruiting
Homburg, Saarland, Germany, 66421
Contact: Urban Sester, MD    0049-6841 ext 1623541   
Medizinische Klinik II, Aachen University Recruiting
Aachen, Germany, 52074
Contact: Anja Mühlfeld, MD   
Charité Berlin Not yet recruiting
Berlin, Germany, 10117
Contact: Lutz Liefeld, MD   
University Erlangen Nürnberg Recruiting
Erlangen, Germany, 91054
Contact: Michael Wiesener, MD   
Contact: Katharina Heller, MD   
Medizinische Klinik III, Frankfurt University Recruiting
Frankfurt, Germany, 60596
Contact: Ingeborg A Hauser, MD    069 - 6301 ext 6668   
Contact: Tilo Freiwald, MD    069 - 6301 ext 6668   
University Clinic of Giessen and Marburg (UKGM) Recruiting
Gießen, Germany, 35392
Contact: Rolf Weimer, MD    0641-985 ext 42398   
Universitätsklinikum Hamburg Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Martina Koch, MD   
Sub-Investigator: Friedrich Thaiss, MD         
Transplantationszentrum Heidelberg - Nephrologie Not yet recruiting
Heidelberg, Germany, 69120
Contact: Claudia Sommerer, MD    0049 6221 56 ext 6110   
Klinikum Köln-Lindenthal Not yet recruiting
Köln, Germany, 50935
Contact: Christine Kurschat, MD   
University of Lübeck Recruiting
Lubeck, Germany, 23538
Contact: Martin Nitschke, MD   
Contact: Inge Derad, MD   
University of Mainz Recruiting
Mainz, Germany, 55131
Contact: Jens Lutz, MD   
University of Münster Not yet recruiting
Muenster, Germany
Contact: Barbara Suwelack, MD   
Innere Medizin IV, University of Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Martina Guthoff, MD    0049-7071-29 ext 83172   
Contact: Nils Heyne, MD    0049-7071-29 ext 83172   
Sponsors and Collaborators
Martina Sester

Responsible Party: Martina Sester, Univ.-Prof. Dr. Martina Sester, Saarland University Identifier: NCT02633826     History of Changes
Other Study ID Numbers: Pre-formed alloreactivity
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Martina Sester, Saarland University:
alloreactive T cell
donor-specific antibody