Disorder Related to Renal TransplantationGABIINCT02843841
Polyclonal Antilymphocyte Globulin (ATG) & Intestinal Immune Barrier After Kidney Transplantation
A study testing Blood and fecal sample. in people with Disorder Related to Renal Transplantation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The prevention of allograft rejection in kidney transplantation requires administering to the patient an immunosuppressive regimen of induction. The induction strategy is based on an injection of polyclonal anti-lymphocyte globulin (ATG-FLAG or fresenius®) driving a lymphocyte lysis, or an injection of monoclonal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorder Related to Renal Transplantation
- What is being tested?
- Blood and fecal sample.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to 1 Mar 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 80 years included
- Postmenopausal women for at least 24 months, sterilized surgically, or for women of childbearing age, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, method of double-barrier contraceptive patches)
- Participation in the study ORLY East
- Signature of informed consent for participation indicating that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study
- Join a French social security or receiving such a plan
Who cannot join
- Legal incapacity or limited legal capacity
- Topic unlikely to cooperate in the study and / or low early cooperation by the investigator
- Without health insurance Topic
- Pregnant woman
- Inability to understand the reasons for the study; psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study
- Infectious episode with need for hospitalization older than 1 month
Show all 10Show fewer
- Active infection by the virus of hepatitis B and / or C
- Active infection by HIV or not
- Patients with inflammatory bowel disease (IBD)
- Patients who have undergone total colectomy
Trial locations and contacts
1 site in 1 country.
About this study
The prevention of allograft rejection in kidney transplantation requires administering to the patient an immunosuppressive regimen of induction. The induction strategy is based on an injection of polyclonal anti-lymphocyte globulin (ATG-FLAG or fresenius®) driving a lymphocyte lysis, or an injection of monoclonal antibodies directed against non-lymphopenic the α chain of the IL-receptor 2 (anti-CD25 antibody, basiliximab), by immunological risk patients. Our group showed a significant increase in death rates in transplant patients with lymphopenia CD4 continued beyond 2 years of transplantation. This excess mortality is related to complications following chronic inflammation observed in some patients lymphopenic.
Preliminary studies have shown that the induced lymphodéplétion ATG appears to be accompanied by an increase of the bacterial products in the blood of transplanted since a significant increase in the sCD14 is observed in these patients one year. We also observed increased concentrations of LPS in patients in the ATG group. This could indicate a secondary bacterial intestinal translocation to a weakening of intestinal immunity linked to the ATG.
Read more
The main objective of the study is to assess the impact of anti-lymphocyte globulin polyclonal on intestinal permeability, estimated by the rate lipopolysaccharide (LPS, a constituent of the cell wall of Gram-negative bacteria) blood after kidney transplantation.
The secondary objectives are to evaluate bacterial translocation, the effect of bacterial translocation on structural and metabolic functions of the intestinal epithelium, chronic inflammation, immune reconstitution, regeneration, activation and proliferation of T lymphocytes, the polymorphism of the LPS receptor that causes the activation of innate immunity and the composition of the intestinal microbiota.
The study population consists of renal transplant patients of Nephrology of the University Hospital of Besancon. Patients will be divided into 2 groups according to induction immunosuppressive therapy prescribed the day of renal transplantation as part of their usual care, ie treatment with anti-lymphocyte globulin polyclonal (ATG-Fresenius®) or antibody treatment monoclonal anti-CD25 (basiliximab Simulect). The patient group treated with anti-CD25 antibody will serve as a control group (no depletion of the immune system) to the group of patients treated with ATG.
- Being tested
- Blood and fecal sample.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and fecal sample.Other
Blood (28 ml) and fecal sample at day 0, 4 days, 3 months and one year after transplantation
| Study group | Role | What they receive |
|---|---|---|
| ATG group | Other | Renal transplant Patients from Nephrology department of the University Hospital of Besancon receiving induction immunosuppressive therapy of polyclonal antilymphocyte globulin (ATG-Fresenius®) as recommended.
Intervention = blood and fecal sample Receives: Other: Blood and fecal sample. |
| Anti-CD25 group | Other | PRenal transplant Patients from Nephrology department of the University Hospital of Besancon receiving induction immunosuppressive therapy of anti-CD25 monoclonal antibodies (basiliximab SIMULECT®) as recommended.
Intervention = blood and fecal sample Receives: Other: Blood and fecal sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum LPS rate
LPS serum levels of kidney transplant patients treated with ATG evaluated by liquid chromatography coupled with mass spectroscopy before transplantation and 1 year after transplantation compared to renal transplant patients treated with anti-CD25 antibody.
Measured: 1 year
Secondary outcomes (7)
The serum levels of LPS.
The results will be correlated to clinical data reported during the first year following the day of transplantation, namely: CMV disease, severe opportunistic infections bacterial infections, atherosclerotic events, dialysis back, patient treatment (antibiotics, standard treatment at the time of sampling).
Measured: 0, 4 days and 3 months after transplantation
The serum levels of translocation marker and intestinal integrity (CD14, citrulline, LBP, CETP, PLTP, IFABP)
All secondary endpoints will be measured at 0, 4 days, 3 and 12 months after transplantation. The results will be correlated to clinical data reported during the first year following the day of transplantation, namely: CMV disease, severe opportunistic infections bacterial infections, atherosclerotic events, dialysis back, patient treatment (antibiotics, standard treatment at the time of sampling).
Measured: 0, 4 days, 3 months and one year after transplantation
The serum levels of inflammatory cytokines (IL-1β, IL-6, TNF-α, IL-8, IL 12, CRP)
All secondary endpoints will be measured at 0, 4 days, 3 and 12 months after transplantation. The results will be correlated to clinical data reported during the first year following the day of transplantation, namely: CMV disease, severe opportunistic infections bacterial infections, atherosclerotic events, dialysis back, patient treatment (antibiotics, standard treatment at the time of sampling).
Measured: 0, 4 days, 3 months and one year after transplantation
The serum levels of regeneration cytokines (IL-7, IL-15 and IL-22)
All secondary endpoints will be measured at 0, 4 days, 3 and 12 months after transplantation. The results will be correlated to clinical data reported during the first year following the day of transplantation, namely: CMV disease, severe opportunistic infections bacterial infections, atherosclerotic events, dialysis back, patient treatment (antibiotics, standard treatment at the time of sampling).
Measured: 0, 4 days, 3 months and one year after transplantation
Serum percentage of CD8+CD57+CD28- LT, CD31+CD4+CD45RA+ LT, Lin-CD34+CD45+CD10+CD38+CD117-CD45RA+ LT, CD3+CD4/8+HLADR+CD38+ LT, Ki67
All secondary endpoints will be measured at 0, 4 days, 3 and 12 months after transplantation. The results will be correlated to clinical data reported during the first year following the day of transplantation, namely: CMV disease, severe opportunistic infections bacterial infections, atherosclerotic events, dialysis back, patient treatment (antibiotics, standard treatment at the time of sampling).
Measured: 0, 4 days, 3 months and one year after transplantation
TLR-4 polymorphism
All secondary endpoints will be measured at 0, 4 days, 3 and 12 months after transplantation. The results will be correlated to clinical data reported during the first year following the day of transplantation,
Measured: 0, 4 days, 3 months and one year after transplantation
The composition of the intestinal microbiota.
All secondary endpoints will be measured at 0, 4 days, 3 and 12 months after transplantation. The results will be correlated to clinical data reported during the first year following the day of transplantation,
Measured: 0, 4 days, 3 months and one year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startDec 2014
- Primary completion1 Mar 2016
- Study completion1 Mar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamal Bamoulid, Dr., Principal investigator, Besancon University Hospital - Nephrology departement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843841
- Sponsor's protocol ID
- P/2014/221
- Acronym
- GABII
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2016
- Last updated
- 31 Jan 2017
- 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 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyclonal Antilymphocyte Globulin (ATG) & Intestinal Immune Barrier After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT02843841
- Acronym / sponsor ID
- GABII / P/2014/221
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2017 (estimated)
- First posted
- 26 Jul 2016 (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.
The prevention of allograft rejection in kidney transplantation requires administering to the patient an immunosuppressive regimen of induction. The induction strategy is based on an injection of polyclonal anti-lymphocyte globulin (ATG-FLAG or fresenius®) driving a lymphocyte lysis, or an injection of monoclonal antibodies directed against non-lymphopenic the α chain of the IL-receptor 2 (anti-CD25 antibody, basiliximab), by immunological risk patients. Our group showed a significant increase in death rates in transplant patients with lymphopenia CD4 continued beyond 2 years of transplantation. This excess mortality is related to complications following chronic inflammation observed in some patients lymphopenic.
Preliminary studies have shown that the induced lymphodéplétion ATG appears to be accompanied by an increase of the bacterial products in the blood of transplanted since a significant increase in the sCD14 is observed in these patients one year. We also observed increased concentrations of LPS in patients in the ATG group. This could indicate a secondary bacterial intestinal translocation to a weakening of intestinal immunity linked to the ATG.
The main objective of the study is to assess the impact of anti-lymphocyte globulin polyclonal on intestinal permeability, estimated by the rate lipopolysaccharide (LPS, a constituent of the cell wall of Gram-negative bacteria) blood after kidney transplantation.
The secondary objectives are to evaluate bacterial translocation, the effect of bacterial translocation on structural and metabolic functions of the intestinal epithelium, chronic inflammation, immune reconstitution, regeneration, activation and proliferation of T lymphocytes, the polymorphism of the LPS receptor that causes the activation of innate immunity and the composition of the intestinal microbiota.
The study population consists of renal transplant patients of Nephrology of the University Hospital of Besancon. Patients will be divided into 2 groups according to induction immunosuppressive therapy prescribed the day of renal transplantation as part of their usual care, ie treatment with anti-lymphocyte globulin polyclonal (ATG-Fresenius®) or antibody treatment monoclonal anti-CD25 (basiliximab Simulect). The patient group treated with anti-CD25 antibody will serve as a control group (no depletion of the immune system) to the group of patients treated with ATG.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATG group | Other | Other: Blood and fecal sample.Renal transplant Patients from Nephrology department of the University Hospital of Besancon receiving induction immunosuppressive therapy of polyclonal antilymphocyte globulin (ATG-Fresenius®) as recommended. Intervention = blood and fecal sample |
| Anti-CD25 group | Other | Other: Blood and fecal sample.PRenal transplant Patients from Nephrology department of the University Hospital of Besancon receiving induction immunosuppressive therapy of anti-CD25 monoclonal antibodies (basiliximab SIMULECT®) as recommended. Intervention = blood and fecal sample |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 18 to 80 years included
- Postmenopausal women for at least 24 months, sterilized surgically, or for women of childbearing age, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, method of double-barrier contraceptive patches)
- Participation in the study ORLY East
- Signature of informed consent for participation indicating that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study
- Join a French social security or receiving such a plan
Key exclusion criteria (10 listed)
- Legal incapacity or limited legal capacity
- Topic unlikely to cooperate in the study and / or low early cooperation by the investigator
- Without health insurance Topic
- Pregnant woman
- Inability to understand the reasons for the study; psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study
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 and fecal sample.Blood (28 ml) and fecal sample at day 0, 4 days, 3 months and one year after transplantation | Other | ATG group, Anti-CD25 group |
Primary outcome
Serum LPS rate
Time frame: 1 year
LPS serum levels of kidney transplant patients treated with ATG evaluated by liquid chromatography coupled with mass spectroscopy before transplantation and 1 year after transplantation compared to renal transplant patients treated with anti-CD25 antibody.
7 secondary outcomes
The serum levels of LPS.
Time frame: 0, 4 days and 3 months after transplantation
The serum levels of translocation marker and intestinal integrity (CD14, citrulline, LBP, CETP, PLTP, IFABP)
Time frame: 0, 4 days, 3 months and one year after transplantation
The serum levels of inflammatory cytokines (IL-1β, IL-6, TNF-α, IL-8, IL 12, CRP)
Time frame: 0, 4 days, 3 months and one year after transplantation
The serum levels of regeneration cytokines (IL-7, IL-15 and IL-22)
Time frame: 0, 4 days, 3 months and one year after transplantation
Serum percentage of CD8+CD57+CD28- LT, CD31+CD4+CD45RA+ LT, Lin-CD34+CD45+CD10+CD38+CD117-CD45RA+ LT, CD3+CD4/8+HLADR+CD38+ LT, Ki67
Time frame: 0, 4 days, 3 months and one year after transplantation
TLR-4 polymorphism
Time frame: 0, 4 days, 3 months and one year after transplantation
The composition of the intestinal microbiota.
Time frame: 0, 4 days, 3 months and one year after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- 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.
Jamal Bamoulid, Dr. principal investigator
Besancon University Hospital - Nephrology departement
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 and fecal sample. in people with Disorder Related to Renal Transplantation, run by Centre Hospitalier Universitaire de Besancon 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 5 inclusion and 10 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 31 Jan 2017. 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?
Results are not available in the source record.
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?
Serum LPS rate (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 31 Jan 2017.