Occurrence of Acute Kidney Injury After CAR-T Cells Treatments in B-cell Lymphoma.

Incidence and Risk Factors of Acute Kidney Injury (AKI) After Anti-CD19 CAR-T Cells Treatments in B-cell Lymphoma and Long Term Evolution.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07101913

Acronym

AKI CAR

Enrollment

300

Registered

2025-08-03

Start date

2025-04-01

Completion date

2026-04-01

Last updated

2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury (AKI), B Cell Lymphoma, Infusion of CD19 CAR T Cell

Keywords

Acute kidney injury/ CD19 CAR T cells

Brief 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.

Interventions

BIOLOGICALIncidence 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.

OTHERDescribe 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.

OTHERFocus on patient with chronic kidney disease at baseline

Looking at the subgroup with chronic kidney disease at baseline : are the outcomes different in this population ? Efficacity of CAR-T ? More adverse effects ?

OTHERLong term evolution after treatment by CAR-T cells

Creatinine measurement 1 year after CAR-T treatment. Informations found in medical field.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients followed in haematology center in Hospices civils de Lyon * For a B-cell lymphoma * Treated by anti-CD19 CAR-T cells

Exclusion criteria

* Less than 18 years old * Patients with legal protection measure * CAR-T cells therapy for another disease : leukemia, autoimmune disease…

Design outcomes

Primary

Measure	Time frame
Incidence of AKI after CAR-T cell therapy in B-cell lymphoma. In percentage, according to the 2012 KDIGO.	AKI from the day of the injection of CAR-T cells, until 28 days after the injection.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026