Antibody-mediated RejectionPROCARE2NCT05140018
Incidence, Course and Outcome of ABMR in Kidney Transplantation
An observational study of Antibody-mediated Rejection and Kidney Transplantation, run by University Medical Center Groningen at 6 sites in Netherlands.
Trial summary
Rationale: Despite improved patient and graft survival in renal transplant recipients, still 20% of the patients reaches end-stage renal disease within 5 years after transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibody-mediated Rejection, Kidney Transplantation, Immunosuppression
- What is being tested?
- Kidney Transplantation, Immunosuppression and Nephrectomy (kidney donation)
- Type of treatment
- Surgery or procedure
- How many people
- 225 participants
- Where
- 6 sitesNetherlands
- Study dates
- 1 Jan 2022to 1 Mar 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with eind-stage renale disease (ESRD) who are about to receive a kidney transplant from a living or deceased donor, with an elevated immunological risk (higher risk for (antibody-mediated) rejection).
Who may be able to join
- Kidney transplant recipients ≥18 years old
- About to receive a post mortal or living donor renal transplant
- written informed consent (is able to read of understand in Dutch)
- Immunological high risk for rejection
- Luminex positive DSAs ; or
- Retransplantation with repeated mismatch ; or
- Husband to wife donation (after fathering children); or
- Offspring to mother donation
Who cannot join
- No immunological high risk
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Recruiting
Academisch Medisch Centrum
Amsterdam
Frederike Bemelman, MD, PhD
Frederike Bemelman, MD, PhD
- Recruiting
University Medical Center Groningen
Groningen
Jan-Stephan Sanders, MD, PhD, +31503616161, j.sanders@umcg.nl
Jan-Stephan Sanders, MD, PhD
- Recruiting
Leiden University Medical Center
Leiden
Aiko de Vries, MD, PhD
Aiko de Vries, MD, PhD
- Recruiting
Radboud University Hospital
Nijmegen
Marije Baas, MD, PhD
- Recruiting
Erasmus MC
Rotterdam
Dennis Hesselink, MD, PhD
- Recruiting
UMCU
Utrecht
Arjan Van Zuilen, MD, PhD
About this study
Official title: Incidence, Course and Outcome of Cellular and Antibody-mediated Rejection in Immunological High-risk Kidney Transplantation, a Prospective Cohort PROCARE2 Study
Rationale: Despite improved patient and graft survival in renal transplant recipients, still 20% of the patients reaches end-stage renal disease within 5 years after transplantation. Antibody-mediated rejection (ABMR) is one of the major causes of early graft loss and perhaps even more important of late deterioration of graft function
Objective: Evaluate the occurrence of antibody mediated rejection (ABMR) and mixed ABMR and cellular/ T-cell mediated rejection (TCMR), in patients treated with the currently prevailing immunosuppressive regimens, and relate them to outcome (graft survival, function, proteinuria, histology)
Read more
Study design: Clinical cohort study.
Study population: patients of >18 years old, about to receive a post mortal of living donor renal transplant with an immunological high risk for ABMR.
Main study parameters/endpoints: main study endpoints are the occurrence of ABMR, mixed ABMR/TCMR and renal function after 1 year of follow-up.
The main study parameter will be mapping the immune system, including B-cells, (non-)HLA antibodies, interaction between B-cells and T follicular helper cells, and complete immune profiling.
- Being tested
- Kidney Transplantation, Immunosuppression, Nephrectomy (kidney donation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney TransplantationProcedure or surgery
All participants will receive a kidney transplantation from a living donor or deceased donor
ImmunosuppressionCombination product
All participants will receive immunosuppresive drugs to prevent rejection of de kidney transplant graft.
Nephrectomy (kidney donation)Procedure or surgery
All kidney donors will receive a nephrectomy for kidney donation
| Study group | Role | What they receive |
|---|---|---|
| Kidney Transplant Recipients with an immunological high risk for ABMR | * Kidney transplant recipients ≥18 years old
* About to receive a post mortal or living donor renal transplant
* Immunological high risk for rejection
1. Luminex positive DSAs ; or
2. Retransplantation with repeated mismatch ; or
3. Husband to wife donation (after fathering children); or
4. Offspring to mother donation Receives: Procedure: Kidney Transplantation; Combination Product: Immunosuppression | |
| Living Kidney Donors | Participants who are about to donate their kidney to a Recipient with a high immunological risk (as described above) Receives: Procedure: Nephrectomy (kidney donation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Antibody-Mediated Rejection (ABMR)
Incidence of Antibody-Mediated Rejection (ABMR) as histopathological diagnosis
Measured: within 12 months after transplantation
Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection (ABMR/TCMR)
Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection as histopathological diagnosis(ABMR/TCMR) as histopathological diagnosis
Measured: within 12 months after transplantation
Kidney transplant function
as measured by eGFR and proteinuria
Measured: at 12 months after transplantation
Secondary outcomes (3)
Development of Human-Leukocyte Antigen (HLA) antibodies
As measured by Luminex assay at 3 and 12 months
Measured: At 3 and 12 months after transplantation
Development of non-HLA antibodies
Development of non-HLA antibodies as measured by a cell-based endothelial assay
Measured: At 3 and 12 months after transplantation
Kidney transplant survival
Kidney transplant survival in patients experiencing ABMR versus those not experiencing ABMR
Measured: At 12 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Jan 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody-mediated RejectionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation, UMC Utrecht, Leiden University Medical Center, Maastricht University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Radboud University Medical Center
- Responsible party
- Principal investigator, J.S.F. Sanders, University Medical Center Groningen
- Investigators
- Hendrikus Otten, PhD, Study chair, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140018
- Sponsor's protocol ID
- PROCARE2
- Acronym
- PROCARE2
- Status last verified
- May 2023
- First submitted
- 17 Nov 2021
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Course and Outcome of Cellular and Antibody-mediated Rejection in Immunological High-risk Kidney Transplantation, a Prospective Cohort PROCARE2 Study
- ClinicalTrials.gov ID
- NCT05140018
- Acronym / sponsor ID
- PROCARE2 / PROCARE2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation, UMC Utrecht, Leiden University Medical Center, Maastricht University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Radboud University Medical Center
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Dec 2021 (actual)
- 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.
Rationale: Despite improved patient and graft survival in renal transplant recipients, still 20% of the patients reaches end-stage renal disease within 5 years after transplantation. Antibody-mediated rejection (ABMR) is one of the major causes of early graft loss and perhaps even more important of late deterioration of graft function
Objective: Evaluate the occurrence of antibody mediated rejection (ABMR) and mixed ABMR and cellular/ T-cell mediated rejection (TCMR), in patients treated with the currently prevailing immunosuppressive regimens, and relate them to outcome (graft survival, function, proteinuria, histology)
Study design: Clinical cohort study.
Study population: patients of >18 years old, about to receive a post mortal of living donor renal transplant with an immunological high risk for ABMR.
Main study parameters/endpoints: main study endpoints are the occurrence of ABMR, mixed ABMR/TCMR and renal function after 1 year of follow-up.
The main study parameter will be mapping the immune system, including B-cells, (non-)HLA antibodies, interaction between B-cells and T follicular helper cells, and complete immune profiling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplant Recipients with an immunological high risk for ABMR | – | Procedure: Kidney Transplantation, Combination Product: Immunosuppression* Kidney transplant recipients ≥18 years old * About to receive a post mortal or living donor renal transplant * Immunological high risk for rejection 1. Luminex positive DSAs ; or 2. Retransplantation with repeated mismatch ; or 3. Husband to wife donation (after fathering children); or 4. Offspring to mother donation |
| Living Kidney Donors | – | Procedure: Nephrectomy (kidney donation)Participants who are about to donate their kidney to a Recipient with a high immunological risk (as described above) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with eind-stage renale disease (ESRD) who are about to receive a kidney transplant from a living or deceased donor, with an elevated immunological risk (higher risk for (antibody-mediated) rejection).
Key inclusion criteria (8 listed)
- Kidney transplant recipients ≥18 years old
- About to receive a post mortal or living donor renal transplant
- written informed consent (is able to read of understand in Dutch)
- Immunological high risk for rejection
Key exclusion criteria (1 listed)
- No immunological high risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney TransplantationAll participants will receive a kidney transplantation from a living donor or deceased donor | Procedure or surgery | Kidney Transplant Recipients with an immunological high risk for ABMR |
| ImmunosuppressionAll participants will receive immunosuppresive drugs to prevent rejection of de kidney transplant graft. | Combination product | Kidney Transplant Recipients with an immunological high risk for ABMR |
| Nephrectomy (kidney donation)All kidney donors will receive a nephrectomy for kidney donation | Procedure or surgery | Living Kidney Donors |
Primary outcome
Incidence of Antibody-Mediated Rejection (ABMR)
Time frame: within 12 months after transplantation
Incidence of Antibody-Mediated Rejection (ABMR) as histopathological diagnosis
Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection (ABMR/TCMR)
Time frame: within 12 months after transplantation
Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection as histopathological diagnosis(ABMR/TCMR) as histopathological diagnosis
Kidney transplant function
Time frame: at 12 months after transplantation
as measured by eGFR and proteinuria
3 secondary outcomes
Development of Human-Leukocyte Antigen (HLA) antibodies
Time frame: At 3 and 12 months after transplantation
Development of non-HLA antibodies
Time frame: At 3 and 12 months after transplantation
Kidney transplant survival
Time frame: At 12 months after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- 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.
Hendrikus Otten, PhD study chair
UMC Utrecht
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibody-mediated Rejection and Kidney Transplantation, run by University Medical Center Groningen at 6 sites in Netherlands.
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 8 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan-Stephan Sanders, MD PhD (+31503612955, j.sanders@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Antibody-Mediated Rejection (ABMR) (time frame: within 12 months after transplantation). The study lists 3 primary outcomes in all. 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 11 May 2023.