Acute Kidney Injury (AKI)AKI CARNCT07101913
Occurrence of Acute Kidney Injury After CAR-T Cells Treatments in B-cell Lymphoma.
An observational study of Acute Kidney Injury (AKI) and Infusion of CD19 CAR T Cell, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The investigators want to describe the incidence of AKI after CAR-T cells therapy in B-cell lymphoma. With the aim of highlight risk factors in AKI occurrence. Then, look at outcomes in the subgroup with chronic kidney disease at baseline. Finally, the investigators will examine long term evolution of kidney function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury (AKI), Infusion of CD19 CAR T Cell, B Cell Lymphoma
- What is being tested?
- Incidence of acute kidney injury, Describe risk factors in AKI occurrence. and Focus on patient with chronic kidney disease at baseline
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.
Who may be able to join
- Patients followed in haematology center in "Hospices civils de Lyon"
- For a B-cell lymphoma
- Treated by anti-CD19 CAR-T cells
Who cannot join
- Less than 18 years old
- Patients with legal protection measure
- CAR-T cells therapy for another disease : leukemia, autoimmune disease…
Trial locations and contacts
1 site in 1 country.
France1 site
Nephrology department, Centre hospitalier Lyon Sud
Pierre-Bénite, France, 69495
About this study
Official title: Incidence and Risk Factors of Acute Kidney Injury (AKI) After Anti-CD19 CAR-T Cells Treatments in B-cell Lymphoma and Long Term Evolution.
The investigators want to describe the incidence of AKI after CAR-T cells therapy in B-cell lymphoma. With the aim of highlight risk factors in AKI occurrence. Then, look at outcomes in the subgroup with chronic kidney disease at baseline. Finally, the investigators will examine long term evolution of kidney function.
- Being tested
- Incidence of acute kidney injury, Describe risk factors in AKI occurrence., Focus on patient with chronic kidney disease at baseline, Long term evolution after treatment by CAR-T cells
- Keywords
- Acute kidney injury/ CD19 CAR T cells
- Medical subject headings
- Acute Kidney Injury, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incidence of acute kidney injuryBiological
- Creatinine measurement before lymphodepletion chemotherapy, before CAR-T cells injection (day 0) and at day 1, day 3, day 5, day 7, day 10, day 14, day 21 and day 28.
- AKI according to 2012 KDIGO.
Describe risk factors in AKI occurrence.Other
Comparison of caracteristics between participants with AKI and participants without AKI :
- Baseline caracteristics of participants : age, gender, BMI (Body mass index), medical history…
- Caracteristics of hematology disease : severity of lymphoma, previous treatments (chemotherapy, autologous/allogenic stem cell transplant), type of CAR-T cells (axi-cel, tisa-cel)
- Other adverse affects : cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS)
- Use of nephrotoxic medications Informations found in medical field.
Focus on patient with chronic kidney disease at baselineOther
Looking at the subgroup with chronic kidney disease at baseline : are the outcomes different in this population ? Efficacity of CAR-T ? More adverse effects ?
Long term evolution after treatment by CAR-T cellsOther
Creatinine measurement 1 year after CAR-T treatment. Informations found in medical field.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cells treatment | All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells. Receives: Biological: Incidence of acute kidney injury; Other: Describe risk factors in AKI occurrence.; Other: Focus on patient with chronic kidney disease at baseline; Other: Long term evolution after treatment by CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI after CAR-T cell therapy in B-cell lymphoma. In percentage, according to the 2012 KDIGO.
Measured: AKI from the day of the injection of CAR-T cells, until 28 days after the injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury (AKI)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101913
- Sponsor's protocol ID
- 24-5297
- Acronym
- AKI CAR
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Acute Kidney Injury (AKI) After Anti-CD19 CAR-T Cells Treatments in B-cell Lymphoma and Long Term Evolution.
- ClinicalTrials.gov ID
- NCT07101913
- Acronym / sponsor ID
- AKI CAR / 24-5297
- Keywords
- Acute kidney injury/ CD19 CAR T cells
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 3 Aug 2025 (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.
The investigators want to describe the incidence of AKI after CAR-T cells therapy in B-cell lymphoma. With the aim of highlight risk factors in AKI occurrence. Then, look at outcomes in the subgroup with chronic kidney disease at baseline. Finally, the investigators will examine long term evolution of kidney function.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T cells treatment | – | Biological: Incidence of acute kidney injury, Other: Describe risk factors in AKI occurrence., Other: Focus on patient with chronic kidney disease at baseline, Other: Long term evolution after treatment by CAR-T cellsAll patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.
Key inclusion criteria (3 listed)
- Patients followed in haematology center in "Hospices civils de Lyon"
- For a B-cell lymphoma
- Treated by anti-CD19 CAR-T cells
Key exclusion criteria (3 listed)
- Less than 18 years old
- Patients with legal protection measure
- CAR-T cells therapy for another disease : leukemia, autoimmune disease…
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 |
|---|---|---|
| Incidence of acute kidney injury* Creatinine measurement before lymphodepletion chemotherapy, before CAR-T cells injection (day 0) and at day 1, day 3, day 5, day 7, day 10, day 14, day 21 and day 28. * AKI according to 2012 KDIGO. | Biological | CAR-T cells treatment |
| Describe risk factors in AKI occurrence.Comparison of caracteristics between participants with AKI and participants without AKI : * Baseline caracteristics of participants : age, gender, BMI (Body mass index), medical history… * Caracteristics of hematology disease : severity of lymphoma, previous treatments (chemotherapy, autologous/allogenic stem cell transplant), type of CAR-T cells (axi-cel, tisa-cel) * Other adverse affects : cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) * Use of nephrotoxic medications Informations found in medical field. | Other | CAR-T cells treatment |
| Focus on patient with chronic kidney disease at baselineLooking at the subgroup with chronic kidney disease at baseline : are the outcomes different in this population ? Efficacity of CAR-T ? More adverse effects ? | Other | CAR-T cells treatment |
| Long term evolution after treatment by CAR-T cellsCreatinine measurement 1 year after CAR-T treatment. Informations found in medical field. | Other | CAR-T cells treatment |
Primary outcome
Incidence of AKI after CAR-T cell therapy in B-cell lymphoma. In percentage, according to the 2012 KDIGO.
Time frame: AKI from the day of the injection of CAR-T cells, until 28 days after the injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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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 Acute Kidney Injury (AKI) and Infusion of CD19 CAR T Cell, run by Hospices Civils de Lyon 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 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of AKI after CAR-T cell therapy in B-cell lymphoma. In percentage, according to the 2012 KDIGO. (time frame: AKI from the day of the injection of CAR-T cells, until 28 days after the injection.). 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 3 Aug 2025.