Kidney TransplantationNCT05282875
Anti-HLA Immunization And Immunosuppressive Therapy Management In Kidney Transplant Patients Returning to Dialysis
An observational study of Kidney Transplantation and Immunosuppressive Agents, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This study is an analytical observational retrospective cohort study. It is a single-center study conducted in the Nancy University Hospital. End stage renal disease is the ultimate stage of the chronic kidney disease. Patients need extra-renal replacement techniques. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplantation, Immunosuppressive Agents, HLA Sensitization
- What is being tested?
- management of immunosuppressive therapy
- How many people
- 430 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 1 Sep 2022
- 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
- Child, Adult, Older adult
Study population: The cohort of patients returning to dialysis after graft loss is extracted from the REIN Lorraine registry. Patients returning in dialysis after graft loss between 1st January 2007 and 31st December 2019 are included. From this cohort, 3 groups were created according to the management of their immunosuppressive therapy : maintenance, reduction, and discontinuation. The immunological data of the patients are recovered from the HLA laboratory of the Nancy University Hospital.
Who may be able to join
- Patients included in the Lorraine regional REIN registry over the period 2007-2019,
- Returning in dialysis after a kidney transplantation, with a living or deceased donor.
- On haemodialysis or peritoneal dialysis.
- Registered or not on the waiting-list for retransplantation
Who cannot join
- Patients with graft dysfunction receiving a pre-emptive retransplantation
- Absence of serum tested for anti-HLA (human leukocyte antigen) antibodies after the return to dialysis.
- No information on immunosuppressive agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Anti-HLA Immunization According to Immunosuppressive Therapy Management Modalities in Kidney Transplant Patients Returning to Dialysis in Lorraine Between January 2007 and December 2019
This study is an analytical observational retrospective cohort study. It is a single-center study conducted in the Nancy University Hospital.
End stage renal disease is the ultimate stage of the chronic kidney disease. Patients need extra-renal replacement techniques. Kidney transplantation is the most effective option for survival, quality of life and costs.
Read more
Then long-term immunosuppressive agents are required to prevent allograft rejection and improve graft survival.
The number of patients who return in dialysis after graft loss is increasing and accounts for 10% of incident dialysis patients and 14% of patients on the kidney transplant waiting list registered in 2019. This population may develop complications induced by end-stage renal disease and adverse events related to prolonged exposure to immunosuppressive agents.
There are currently no formal guidelines on the management of immunosuppressive agents when patients return to dialysis. Reduction or discontinuation of therapy appears to decrease cardiovascular, infectious, and neoplastic complications. However, continuing these treatments may limit anti-HLA sensitization which may access to retransplantation.
Only a few low-powered cohort studies have evaluated the impact of the management of immunosuppressive therapy on the HLA-sensitization.
The hypothesis of our study is that the continuation of immunosuppressive agents when patients return in dialysis may limit anti-HLA sensitization. Therefore, access to retransplantation could be facilitated.
The main objective is to compare the evolution of anti-HLA sensitization according to the management of immunosuppressive treatment after the return in dialysis (maintenance, reduction, cessation).
Secondary objectives are time to re-transplantation for patients on the transplant waiting list, survival of the new graft, patient survival, and dialysis complications (cardiovascular, infectious and neoplastic complications).
Read the detailed description
Cohort constitution :
The cohort of patients returning to dialysis after graft loss is extracted from the REIN (Réseau Epidémiologique et Information en Néphrologie) Lorraine registry, which follow all patients in end-stage renal failure under replacement therapy in the Lorraine region since 2001.
Patients returning to dialysis after graft loss between 1st January 2007 and 31st December 2019 are extracted from the register and included.
From this cohort, 3 groups were created according to the management of their immunosuppressive therapy : maintenance, reduction, and discontinuation. The immunological data of the patients are recovered from the HLA laboratory of the Nancy University Hospital.
- Being tested
- management of immunosuppressive therapy
- Keywords
- immunosuppressive agents, graft loss, HLA antibodies, retransplantation, kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of immunosuppressive therapyDrug
3 groups :
- Discontinuation of immunosuppressive agents
- Reduction of immunosuppressive agents
- Maintenance of immunosuppressive agents
| Study group | Role | What they receive |
|---|---|---|
| kidney transplant patients returning to dialysis after graft loss | This cohort contains kidney transplant patients returning to dialysis after graft loss in Lorraine between 1 January 2007 and 31 December 2019. They are identified by the REIN registry of the Lorraine region.
The REIN registry is a national database that contains multiple information on patients with chronic end-stage renal disease (type of nephropathy, type of replacement therapy, comorbidities). Receives: Drug: management of immunosuppressive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the evolution of anti-human leucocyte antigen sensitization according to the management of immunosuppressive therapy
Evolution of the panel reactive antibody evolution 6 months after the return in dialysis
Measured: baseline = return in dialysis, t1=6 months after return in dialysis
Secondary outcomes (4)
Patients survival
Patient survival after return in dialysis
Measured: baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020
New transplantation
Retransplantation after return in dialysis
Measured: baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020
Graft Survival after retransplantation
Graft Survival after retransplantation
Measured: baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020
Incidence of infectious, neoplastic and cardiovascular events
Incidence of infection, neoplastic and cardiovascular events after return in dialysis
Measured: baseline = return in dialysis, end of follow up = 1 year after return in dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Feb 2022
- Primary completion30 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
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.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GIRERD Sophie, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282875
- Sponsor's protocol ID
- 2021PI192
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 5 Apr 2022
- 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 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Anti-HLA Immunization According to Immunosuppressive Therapy Management Modalities in Kidney Transplant Patients Returning to Dialysis in Lorraine Between January 2007 and December 2019
- ClinicalTrials.gov ID
- NCT05282875
- Acronym / sponsor ID
- 2021PI192
- Keywords
- immunosuppressive agents, graft loss, HLA antibodies, retransplantation, kidney transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 16 Mar 2022 (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.
This study is an analytical observational retrospective cohort study. It is a single-center study conducted in the Nancy University Hospital.
End stage renal disease is the ultimate stage of the chronic kidney disease. Patients need extra-renal replacement techniques. Kidney transplantation is the most effective option for survival, quality of life and costs.
Then long-term immunosuppressive agents are required to prevent allograft rejection and improve graft survival.
The number of patients who return in dialysis after graft loss is increasing and accounts for 10% of incident dialysis patients and 14% of patients on the kidney transplant waiting list registered in 2019. This population may develop complications induced by end-stage renal disease and adverse events related to prolonged exposure to immunosuppressive agents.
There are currently no formal guidelines on the management of immunosuppressive agents when patients return to dialysis. Reduction or discontinuation of therapy appears to decrease cardiovascular, infectious, and neoplastic complications. However, continuing these treatments may limit anti-HLA sensitization which may access to retransplantation.
Only a few low-powered cohort studies have evaluated the impact of the management of immunosuppressive therapy on the HLA-sensitization.
The hypothesis of our study is that the continuation of immunosuppressive agents when patients return in dialysis may limit anti-HLA sensitization. Therefore, access to retransplantation could be facilitated.
The main objective is to compare the evolution of anti-HLA sensitization according to the management of immunosuppressive treatment after the return in dialysis (maintenance, reduction, cessation).
Secondary objectives are time to re-transplantation for patients on the transplant waiting list, survival of the new graft, patient survival, and dialysis complications (cardiovascular, infectious and neoplastic complications).
Detailed description
Cohort constitution :
The cohort of patients returning to dialysis after graft loss is extracted from the REIN (Réseau Epidémiologique et Information en Néphrologie) Lorraine registry, which follow all patients in end-stage renal failure under replacement therapy in the Lorraine region since 2001.
Patients returning to dialysis after graft loss between 1st January 2007 and 31st December 2019 are extracted from the register and included.
From this cohort, 3 groups were created according to the management of their immunosuppressive therapy : maintenance, reduction, and discontinuation. The immunological data of the patients are recovered from the HLA laboratory of the Nancy University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| kidney transplant patients returning to dialysis after graft loss | – | Drug: management of immunosuppressive therapyThis cohort contains kidney transplant patients returning to dialysis after graft loss in Lorraine between 1 January 2007 and 31 December 2019. They are identified by the REIN registry of the Lorraine region. The REIN registry is a national database that contains multiple information on patients with chronic end-stage renal disease (type of nephropathy, type of replacement therapy, comorbidities). |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The cohort of patients returning to dialysis after graft loss is extracted from the REIN Lorraine registry. Patients returning in dialysis after graft loss between 1st January 2007 and 31st December 2019 are included. From this cohort, 3 groups were created according to the management of their immunosuppressive therapy : maintenance, reduction, and discontinuation. The immunological data of the patients are recovered from the HLA laboratory of the Nancy University Hospital.
Key inclusion criteria (4 listed)
- Patients included in the Lorraine regional REIN registry over the period 2007-2019,
- Returning in dialysis after a kidney transplantation, with a living or deceased donor.
- On haemodialysis or peritoneal dialysis.
- Registered or not on the waiting-list for retransplantation
Key exclusion criteria (3 listed)
- Patients with graft dysfunction receiving a pre-emptive retransplantation
- Absence of serum tested for anti-HLA (human leukocyte antigen) antibodies after the return to dialysis.
- No information on immunosuppressive agents
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 |
|---|---|---|
| management of immunosuppressive therapy3 groups : * Discontinuation of immunosuppressive agents * Reduction of immunosuppressive agents * Maintenance of immunosuppressive agents | Drug | kidney transplant patients returning to dialysis after graft loss |
Primary outcome
Comparison of the evolution of anti-human leucocyte antigen sensitization according to the management of immunosuppressive therapy
Time frame: baseline = return in dialysis, t1=6 months after return in dialysis
Evolution of the panel reactive antibody evolution 6 months after the return in dialysis
4 secondary outcomes
Patients survival
Time frame: baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020
New transplantation
Time frame: baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020
Graft Survival after retransplantation
Time frame: baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020
Incidence of infectious, neoplastic and cardiovascular events
Time frame: baseline = return in dialysis, end of follow up = 1 year after return in dialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- 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.
1 site 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 Immunosuppressive Agents, run by Central Hospital, Nancy, France 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 4 inclusion and 3 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 5 Apr 2022. 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?
Comparison of the evolution of anti-human leucocyte antigen sensitization according to the management of immunosuppressive therapy (time frame: baseline = return in dialysis, t1=6 months after return in dialysis). 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 5 Apr 2022.