Kidney TransplantationNCT02633826
Pre-formed Alloreactivity in Renal Transplant Recipients
An observational study of Kidney Transplantation and Acute Graft Rejection, run by Martina Sester at 13 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplantation, Acute Graft Rejection
- How many people
- 190 participants
- Where
- 13 sitesGermany
- Study dates
- Nov 2015to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Transplant recipients of a kidney from a living donor
Who may be able to join
- 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)
Who cannot join
- Planed T-cell depleting induction therapy
- Pregnancy
- Pre-existing, moderate to high dose immunosuppressive medication
- Pre-existing, severe lymphopenia (\< 400/µl)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Medizinische Klinik II, Aachen University
Aachen, 52074
Charité Berlin
Berlin, 10117
Klinikum Köln-Lindenthal
Cologne, 50935
University Erlangen Nürnberg
Erlangen, 91054
Medizinische Klinik III, Frankfurt University
Frankfurt, 60596
University Clinic of Giessen and Marburg (UKGM)
Giessen, 35392
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246
Transplantationszentrum Heidelberg - Nephrologie
Heidelberg, 69120
Saarland University
Homburg, Saarland, 66421
University of Lübeck
Lübeck, 23538
University of Mainz
Mainz, 55131
University of Münster
Münster
Innere Medizin IV, University of Tübingen
Tübingen, 72076
About this study
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
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.
Read the 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.
- Conditions
- Kidney Transplantation, Acute Graft Rejection
- Keywords
- alloreactive T cell, donor-specific antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| kidney transplant recipients | kidney transplant recipients of an allograft from a living donor, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft function
1-year graft function (estimated glomerular filtration rate)
Measured: 1 year
Secondary outcomes (4)
Creatinine
1-year creatinine
Measured: 1 year
Cystatin C
1-year cystatin C
Measured: 1 year
rejection: acute rejection episodes within the first year
Measured: 1 year
proteinuria within the first year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2023
- Study completionMar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martina Sester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martina Sester, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633826
- Sponsor's protocol ID
- Pre-formed alloreactivity
- Status last verified
- Apr 2024
- First submitted
- 15 Dec 2015
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02633826
- Acronym / sponsor ID
- Pre-formed alloreactivity
- Conditions
- Kidney Transplantation, Acute Graft Rejection
- Keywords
- alloreactive T cell, donor-specific antibody
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Martina SesterUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| kidney transplant recipients | – | –kidney transplant recipients of an allograft from a living donor, no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Transplant recipients of a kidney from a living donor
Key inclusion criteria (7 listed)
- Written informed consent
- First or second renal transplantation
- Living donor renal transplantation
- Recipient older than 18 years
- Negative cross match
Key exclusion criteria (4 listed)
- Planed T-cell depleting induction therapy
- Pregnancy
- Pre-existing, moderate to high dose immunosuppressive medication
- Pre-existing, severe lymphopenia (\< 400/µl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
graft function
Time frame: 1 year
1-year graft function (estimated glomerular filtration rate)
4 secondary outcomes
Creatinine
Time frame: 1 year
Cystatin C
Time frame: 1 year
rejection: acute rejection episodes within the first year
Time frame: 1 year
proteinuria within the first year
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Acute Graft Rejection, run by Martina Sester at 13 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft function (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.