Pre-formed Alloreactivity in Renal Transplant Recipients
The Role of Pre-formed Alloreactive T Cells on Acute Rejection Episodes and Long-term Graft Outcome in Patients After Living Donor Renal Transplantation
1 other identifier
observational
190
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2015
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 15, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedApril 19, 2024
April 1, 2024
7.3 years
December 15, 2015
April 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
graft function
1-year graft function (estimated glomerular filtration rate)
1 year
Secondary Outcomes (4)
Creatinine
1 year
Cystatin C
1 year
rejection: acute rejection episodes within the first year
1 year
proteinuria within the first year
1 year
Study Arms (1)
kidney transplant recipients
kidney transplant recipients of an allograft from a living donor, no intervention
Eligibility Criteria
Transplant recipients of a kidney from a living donor
You may qualify if:
- 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)
You may not qualify if:
- Planed T-cell depleting induction therapy
- Pregnancy
- Pre-existing, moderate to high dose immunosuppressive medication
- Pre-existing, severe lymphopenia (\< 400/µl)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Martina Sesterlead
Study Sites (13)
Saarland University
Homburg, Saarland, 66421, Germany
Medizinische Klinik II, Aachen University
Aachen, 52074, Germany
Charité Berlin
Berlin, 10117, Germany
Klinikum Köln-Lindenthal
Cologne, 50935, Germany
University Erlangen Nürnberg
Erlangen, 91054, Germany
Medizinische Klinik III, Frankfurt University
Frankfurt, 60596, Germany
University Clinic of Giessen and Marburg (UKGM)
Giessen, 35392, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Transplantationszentrum Heidelberg - Nephrologie
Heidelberg, 69120, Germany
University of Lübeck
Lübeck, 23538, Germany
University of Mainz
Mainz, 55131, Germany
University of Münster
Münster, Germany
Innere Medizin IV, University of Tübingen
Tübingen, 72076, Germany
Biospecimen
Serum
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Univ.-Prof. Dr. Martina Sester
Study Record Dates
First Submitted
December 15, 2015
First Posted
December 17, 2015
Study Start
November 1, 2015
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
April 19, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share