Kidney TransplantA3NCT03423901
Impact of Anti-HLA Donor-specific Antibodies in ABO-incompatible Kidney Transplantation
A study testing Blood sampling in people with Kidney Transplant, run by University Hospital, Toulouse at 1 site in France.
Trial summary
It was previously suggested an improvement of graft survival in ABO/HLA incompatible kidney transplantation (KT) compared with HLA (human leukocyte antigen) incompatible transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2018to 5 May 2018
- Phase
- Interventional
- 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
Who may be able to join
- Patient receiving a KT and followed at least one year in Toulouse Hospital
- Patient who have signed informed consent
- > 18 years old
Who cannot join
- Patient under protective measures
- Patients treated for cancer, infectious or immune disease by molecules that could interfere with lymphocyte populations : Interleukin 6 (IL6) blockers, Programmed cell death 1(PD1) and the cytotoxic T-lymphocyte-associated antigen 4 (CTL4) blockers.
- Immunosuppressive treatments withdrawal - Patient in chronic dialysis
- Ongoing pregnancy or pregnancy in the past year
- Past of splenectomy
Trial locations and contacts
1 site in 1 country.
About this study
It was previously suggested an improvement of graft survival in ABO/HLA incompatible kidney transplantation (KT) compared with HLA (human leukocyte antigen) incompatible transplantation. Here, the investigators would analyse clinical, biological and histological results of ABO/HLA incompatible kidney transplant recipients, comparing with ABO or HLA compatible kidney transplantation.
Read the detailed description
The investigators propose to analyze the clinical, biological and histological course of kidney function, but also to investigate the T and B cells population after KT in ABO incompatible, ABO/HLA incompatible and HLA incompatible kidney transplantation (1 and 7 years posttransplantation in each groups).
- Conditions
- Kidney Transplant
- Being tested
- Blood sampling
- Keywords
- Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Descriptive analysis of clinical, biological and histological of 3 arms: ABO incompatible, HLA incompatible, and ABO/HLA incompatible kidney transplantation (1 and 5 years posttransplantation in each groups)
| Study group | Role | What they receive |
|---|---|---|
| ABO/HLA incompatible KT | Experimental | Blood sampling for descriptive analysis of clinical, biological and histological of 12 ABO and HLA incompatible kidney transplantation (KT) Receives: Other: Blood sampling |
| ABO incompatible KT | Experimental | Blood sampling for descriptive analysis of clinical, biological and histological of 28 ABO incompatible kidney transplantation Receives: Other: Blood sampling |
| HLA incompatible KT | Experimental | Blood sampling for descriptive analysis of clinical, biological and histological of 20 HLA incompatible kidney transplantation Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression related to antibody mediated rejection
To determine expression of genes related to antibody mediated rejection (inflammation, and endothelial cell activation) by transcriptomic analyse (whole genome micro-array) on kidney biopsies
Measured: 1 year posttransplantation
Secondary outcomes (5)
description of T subsets cells
to analyse of T subsets cells after Kidney transplantation in blood samples of patients by flow cytometry
Measured: 1 to 5 years posttransplantation
description of B subsets cells
to analyse of B subsets cells after Kidney transplantation in blood samples of patients by flow cytometry
Measured: 1 to 5 years posttransplantation
description of lymphocytes rates
to analyse rates of lymphocytes after Kidney transplantation in blood samples of patients by flow cytometry
Measured: 1 to 5 years posttransplantation
Evolution of creatinine clearance
to analyse creatinine clearance in blood samples of patients after kidney transplantation
Measured: 1 to 5 years posttransplantation
Evolution of systematic annual kidney biopsies
To analyse the evolution of systematic annual kidney biopsies by microscopy
Measured: 1 to 5 years posttransplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start6 Feb 2018
- Primary completion2 May 2018
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud DEL BELLO, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423901
- Sponsor's protocol ID
- RC31/17/0426
- Acronym
- A3
- Status last verified
- Aug 2019
- First submitted
- 19 Jan 2018
- Last updated
- 20 Aug 2019
- 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 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anti-HLA Donor-specific Antibodies in ABO-incompatible Kidney Transplantation
- ClinicalTrials.gov ID
- NCT03423901
- Acronym / sponsor ID
- A3 / RC31/17/0426
- Conditions
- Kidney Transplant
- Keywords
- Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 6 Feb 2018 (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.
It was previously suggested an improvement of graft survival in ABO/HLA incompatible kidney transplantation (KT) compared with HLA (human leukocyte antigen) incompatible transplantation. Here, the investigators would analyse clinical, biological and histological results of ABO/HLA incompatible kidney transplant recipients, comparing with ABO or HLA compatible kidney transplantation.
Detailed description
The investigators propose to analyze the clinical, biological and histological course of kidney function, but also to investigate the T and B cells population after KT in ABO incompatible, ABO/HLA incompatible and HLA incompatible kidney transplantation (1 and 7 years posttransplantation in each groups).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABO/HLA incompatible KT | Experimental | Other: Blood samplingBlood sampling for descriptive analysis of clinical, biological and histological of 12 ABO and HLA incompatible kidney transplantation (KT) |
| ABO incompatible KT | Experimental | Other: Blood samplingBlood sampling for descriptive analysis of clinical, biological and histological of 28 ABO incompatible kidney transplantation |
| HLA incompatible KT | Experimental | Other: Blood samplingBlood sampling for descriptive analysis of clinical, biological and histological of 20 HLA incompatible kidney transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient receiving a KT and followed at least one year in Toulouse Hospital
- Patient who have signed informed consent
- > 18 years old
Key exclusion criteria (5 listed)
- Patient under protective measures
- Patients treated for cancer, infectious or immune disease by molecules that could interfere with lymphocyte populations : Interleukin 6 (IL6) blockers, Programmed cell death 1(PD1) and the cytotoxic T-lymphocyte-associated antigen 4 (CTL4) blockers.
- Immunosuppressive treatments withdrawal - Patient in chronic dialysis
- Ongoing pregnancy or pregnancy in the past year
- Past of splenectomy
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 |
|---|---|---|
| Blood samplingDescriptive analysis of clinical, biological and histological of 3 arms: ABO incompatible, HLA incompatible, and ABO/HLA incompatible kidney transplantation (1 and 5 years posttransplantation in each groups) | Other | ABO incompatible KT, ABO/HLA incompatible KT, HLA incompatible KT |
Primary outcome
Gene expression related to antibody mediated rejection
Time frame: 1 year posttransplantation
To determine expression of genes related to antibody mediated rejection (inflammation, and endothelial cell activation) by transcriptomic analyse (whole genome micro-array) on kidney biopsies
5 secondary outcomes
description of T subsets cells
Time frame: 1 to 5 years posttransplantation
description of B subsets cells
Time frame: 1 to 5 years posttransplantation
description of lymphocytes rates
Time frame: 1 to 5 years posttransplantation
Evolution of creatinine clearance
Time frame: 1 to 5 years posttransplantation
Evolution of systematic annual kidney biopsies
Time frame: 1 to 5 years posttransplantation
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 20 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant
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Hypothermic Kidney Machine Perfusion With Omnisol
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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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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.
Arnaud DEL BELLO, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Kidney Transplant, run by University Hospital, Toulouse at 1 site in France.
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 3 inclusion and 5 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Gene expression related to antibody mediated rejection (time frame: 1 year posttransplantation). 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 20 Aug 2019.