Renal Replacement Therapy for Acute Kidney Injury in ICUTENDERSNCT06889974
Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome
An observational study of Renal Replacement Therapy for Acute Kidney Injury in ICU, run by University Hospital, Bordeaux at 10 sites in France.
Trial summary
The TENDERS study aims to evaluate the impact of the timing of renal replacement therapy (RRT) initiation on outcomes in patients with tumor lysis syndrome (TLS) and associated acute kidney injury (AKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Replacement Therapy for Acute Kidney Injury in ICU
- How many people
- 800 participants
- Where
- 10 sitesFrance
- Study dates
- 1 Jul 2025to Jul 2027
- 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: This is a retrospective, multicenter cohort study conducted across several intensive care units (ICUs) in France. Data will be collected retrospectively from patient records and analyzed to assess the impact of early versus delayed RRT initiation on clinical outcomes in patients with TLS-induced AKI.
Who may be able to join
- Adults aged ≥18 years.
- Hospitalized in the ICU between January 1, 2013, and December 31, 2023.
- Diagnosed with a hematologic malignancy or solid tumor requiring chemotherapy.
- Diagnosed with TLS based on the presence of two or more biochemical criteria (e.g., hyperkalemia, hyperphosphatemia, hyperuricemia, hypocalcemia) within 3 days before or 7 days after chemotherapy initiation.
Who cannot join
- Patient or family opposition to data collection for research purposes.
- Incomplete medical records that preclude data extraction.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 8 recruiting
- Withdrawn
CHU d'Angers
Angers
- Recruiting
Hôpital Pellegrin
Bordeaux
Arthur ORIEUX, 05 56 79 56 79 ext. +33, arthur.orieux@chu-bordeaux.fr
Alexandre BOYER
- Recruiting
Hôpital la cavale blanche
Brest
Cécile AUBRON, 05 56 79 56 79, cecile.aubron@chu-brest.fr
- Withdrawn
CHU Dupuytren 1
Limoges
- Recruiting
Hôtel-Dieu
Nantes
Emmanuel CANET, 05 56 79 56 79, emmanuel.canet@chu-nantes.fr
- Recruiting
CHR d'Orléans
Orléans
Anne BRETAGNOL, 05 56 79 56 79, anne.bretagnol@chu-orleans.fr
- Recruiting
CH de Pau
Pau
Simon BODOT, 05 56 79 56 79, Simon.BODOT@ch-pau.fr
- Recruiting
Centre Urgences-Réanimations
Rennes
Jean-Marc TADIE, 05 56 79 56 79, jeanmarc.tadie@chu-rennes.fr
- Recruiting
IUCT-O Hopital Purpan
Toulouse
Muriel PICARD, Picard.Muriel@iuct-oncopole.fr
- Recruiting
Hôpital Bretonneau
Tours
Antoine GUILLON, 05 56 79 56 79, antoine.guillon@univ-tours.fr
About this study
The TENDERS study aims to evaluate the impact of the timing of renal replacement therapy (RRT) initiation on outcomes in patients with tumor lysis syndrome (TLS) and associated acute kidney injury (AKI). The study will compare early versus delayed RRT initiation, examining the effect on renal function at 30 days post-treatment.
Read the detailed description
Tumor lysis syndrome (TLS) is a common and life-threatening complication in patients with hematologic malignancies, characterized by severe metabolic imbalances due to rapid tumor cell destruction. This syndrome frequently leads to acute kidney injury (AKI), requiring renal replacement therapy (RRT) in about 50% of cases. Despite its clinical significance, there is a lack of consensus on the optimal timing of RRT initiation in TLS-related AKI. Studies in other forms of AKI suggest no difference in outcomes between early and delayed RRT initiation, but these results are not directly applicable to TLS patients. This study seeks to fill this gap by analyzing the timing and outcomes of RRT initiation in TLS patients. The retrospective study will collect data from multiple intensive care units (ICUs) across France. Procedure: The study will retrospectively analyze patient data from 2013 to 2023, comparing early vs. delayed RRT initiation. Follow-up: Data on renal function, RRT usage, and mortality will be collected 30 days and one year after ICU admission.
- Keywords
- tumoral lysis syndrome, acute kidney injury, renal replacement therapy, timing
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with early initiation of renal replacement therapy (RRT) | Patients with early initiation of RRT, RRT within 24 hours of acute kidney injury (AKI) diagnosis. | |
| Patients with delayed initiation of RRT | Patients with delayed initiation of RRT, RRT initiated only after urgent clinical indications arise, such as severe hyperkalemia or metabolic acidosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal dysfunction at ICU discharge
The primary outcome is renal dysfunction at ICU discharge, defined as a ≥25% increase in serum creatinine from baseline, assessed at the time of ICU discharge.
Measured: From baseline to up to 30 days .
Secondary outcomes (7)
Incidence of AKI
Incidence of AKI related to Tumor lysis syndrome (TLS), assessed at ICU admission.
Measured: At baseline
Use of RRT for TLS-related AKI
Use of RRT for TLS-related AKI, assessed during ICU stay.
Measured: From baseline to up to 30 days.
Renal recovery
90-day renal recovery, assessed at 90 days post-admission.
Measured: At 90 days after baseline
Long-term renal function
Long-term renal function is assessed by creatinine at one year
Measured: 12 months after baseline
Mortality at 30 days
Mortality rate at 30 days.
Measured: 30 days after baseline
Mortality at 12 months
Mortality rate 12 months post ICU admission
Measured: 12 months after baseline
Long-term renal function
Long-term renal function is assessed by glomerular filtration rate at one year
Measured: 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Replacement Therapy for Acute Kidney Injury in ICUStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889974
- Sponsor's protocol ID
- CHUBX 2024/104
- Acronym
- TENDERS
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2025
- Last updated
- 9 Jan 2026
- 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome
- ClinicalTrials.gov ID
- NCT06889974
- Acronym / sponsor ID
- TENDERS / CHUBX 2024/104
- Keywords
- tumoral lysis syndrome, acute kidney injury, renal replacement therapy, timing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 Mar 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 TENDERS study aims to evaluate the impact of the timing of renal replacement therapy (RRT) initiation on outcomes in patients with tumor lysis syndrome (TLS) and associated acute kidney injury (AKI). The study will compare early versus delayed RRT initiation, examining the effect on renal function at 30 days post-treatment.
Detailed description
Tumor lysis syndrome (TLS) is a common and life-threatening complication in patients with hematologic malignancies, characterized by severe metabolic imbalances due to rapid tumor cell destruction. This syndrome frequently leads to acute kidney injury (AKI), requiring renal replacement therapy (RRT) in about 50% of cases. Despite its clinical significance, there is a lack of consensus on the optimal timing of RRT initiation in TLS-related AKI. Studies in other forms of AKI suggest no difference in outcomes between early and delayed RRT initiation, but these results are not directly applicable to TLS patients. This study seeks to fill this gap by analyzing the timing and outcomes of RRT initiation in TLS patients. The retrospective study will collect data from multiple intensive care units (ICUs) across France. Procedure: The study will retrospectively analyze patient data from 2013 to 2023, comparing early vs. delayed RRT initiation. Follow-up: Data on renal function, RRT usage, and mortality will be collected 30 days and one year after ICU admission.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with early initiation of renal replacement therapy (RRT) | – | –Patients with early initiation of RRT, RRT within 24 hours of acute kidney injury (AKI) diagnosis. |
| Patients with delayed initiation of RRT | – | –Patients with delayed initiation of RRT, RRT initiated only after urgent clinical indications arise, such as severe hyperkalemia or metabolic acidosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective, multicenter cohort study conducted across several intensive care units (ICUs) in France. Data will be collected retrospectively from patient records and analyzed to assess the impact of early versus delayed RRT initiation on clinical outcomes in patients with TLS-induced AKI.
Key inclusion criteria (4 listed)
- Adults aged ≥18 years.
- Hospitalized in the ICU between January 1, 2013, and December 31, 2023.
- Diagnosed with a hematologic malignancy or solid tumor requiring chemotherapy.
- Diagnosed with TLS based on the presence of two or more biochemical criteria (e.g., hyperkalemia, hyperphosphatemia, hyperuricemia, hypocalcemia) within 3 days before or 7 days after chemotherapy initiation.
Key exclusion criteria (2 listed)
- Patient or family opposition to data collection for research purposes.
- Incomplete medical records that preclude data extraction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Renal dysfunction at ICU discharge
Time frame: From baseline to up to 30 days .
The primary outcome is renal dysfunction at ICU discharge, defined as a ≥25% increase in serum creatinine from baseline, assessed at the time of ICU discharge.
7 secondary outcomes
Incidence of AKI
Time frame: At baseline
Use of RRT for TLS-related AKI
Time frame: From baseline to up to 30 days.
Renal recovery
Time frame: At 90 days after baseline
Long-term renal function
Time frame: 12 months after baseline
Mortality at 30 days
Time frame: 30 days after baseline
Mortality at 12 months
Time frame: 12 months after baseline
Long-term renal function
Time frame: 12 months after baseline
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 9 Jan 2026.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Replacement Therapy for Acute Kidney Injury in ICU, run by University Hospital, Bordeaux at 10 sites 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 2 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Contact Arthur ORIEUX (05 56 70 56 79 ext. +33, arthur.orieux@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal dysfunction at ICU discharge (time frame: From baseline to up to 30 days .). 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 9 Jan 2026.