Acute Kidney InjuryRCA-FluxNCT07679568
Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation
An observational study of Acute Kidney Injury and Renal Failure, run by Fresenius Medical Care Deutschland GmbH at 1 site in Germany.
Trial summary
The goal of this observational study is to assess the performance of the multiFlux hemofilterwith regional or systemic anticoagulation during CKRT treatments. The multiFlux hemofilter is a single use device within the extracorporeal blood circuit during extracorporeal blood purification treatments for acute renal… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Acute Kidney Injury, Renal Failure
- What is being tested?
- multiFlux 160 hemofilter with regional heparin anticoagulation, multiFlux 160 hemofilter with RCA with regional citrate anticoagulation and multiFlux 130 hemofilter with regional heparin anticoagulation
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2026to Dec 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of critically ill patients (adults and children) requiring continuous kidney replacement therapy (CKRT).
Who may be able to join
- General:
- Patients ≥ 18 years:
- Informed consent signed and dated by the investigator; and
- if patient is able to give consent: by the study patient
- if patients unable to give consent: by the legal representative/spouse according to § 1358 BGB or
- if an emergency situation is determined: by an independent consultant physician.
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- Pediatric Patients < 18 years:
- Informed consent signed and dated by legal representative and investigator/ authorized physician.
- The minors have received the information referred to in Article 63(2) Medical Device Regulation (MDR) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children. If able, the minors have to sign the informed consent, too.
- The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator
- Study specific:
- Body weight ≥ 8kg
- Acute Kidney Injury (AKI) with clinical indication for CKRT
- Clinically estimated life expectancy greater than 3 days
Who cannot join
- Any conditions which could interfere with the patient's ability to comply with the study
- Patient or legal representative or authorized physician during emergency situation is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
- Participation in a different interventional clinical study during the preceding 30 days
- Previous participation in the same study
- Uncontrolled bleeding and coagulation disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
Munich, Bavaria, 81377
Christina Christina Scharf-Janßen, Dr. med., 089-4400-84163, christina.scharf-janssen@med.uni-muenchen.de
About this study
Official title: Analysis of CKRT Treatments With multiFlux Hemofilters Using RCA or Systemic Heparin Anticoagulation
The goal of this observational study is to assess the performance of the multiFlux hemofilterwith regional or systemic anticoagulation during CKRT treatments. The multiFlux hemofilter is a single use device within the extracorporeal blood circuit during extracorporeal blood purification treatments for acute renal replacement therapies.
Read the detailed description
Patients enrolled in this clinical investigation will be treated either with citrate anticoagulation in Continuous venovenous hemodialysis (CVVHD) or Continuous venovenous hemodiafiltration (CVVHDF) in post-dilution mode (RCA-post-CVVHDF) with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier)) or with heparin in any of the possible CKRT modes (pre-, post- or pre-post CVVH, CVVHD, pre-, post- or pre-post CVVHDF) for up to 10 days based on investigator´s decision (data beyond 10 days will not be collected within the study) or until withdrawal of informed consent or death.
For the study, treatment data will be documented for a maximum of 10 days.
The selection of the filter size depends on the prescription of the attending physician. The body weight limitations as shall be considered:
Mutiflux 160 ≥ 40 kg, Multiflux 130 ≥ 30 kg, Multiflux 60 ≥ 8 kg
- Conditions
- Acute Kidney Injury, Renal Failure
- Being tested
- multiFlux 160 hemofilter with regional heparin anticoagulation, multiFlux 160 hemofilter with RCA with regional citrate anticoagulation, multiFlux 130 hemofilter with regional heparin anticoagulation, multiFlux 130 hemofilter with RCA with regional citrate anticoagulation, multiFlux 60 hemofilter with regional heparin anticoagulation
- Keywords
- Continuous kidney replacement therapy, Regional citrate anticoagulation, Systemic heparin anticoagulation
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiFlux 160 hemofilter with regional heparin anticoagulationDevice
Extracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
multiFlux 160 hemofilter with RCA with regional citrate anticoagulationDevice
Extracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)
multiFlux 130 hemofilter with regional heparin anticoagulationDevice
Extracorporeal blood purification with the multiFlux 130 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
multiFlux 130 hemofilter with RCA with regional citrate anticoagulationDevice
Extracorporeal blood purification with the multiFlux130 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)
multiFlux 60 hemofilter with regional heparin anticoagulationDevice
Extracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
multiFlux 60 hemofilter with RCA with regional citrate anticoagulationDevice
Extracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)
| Study group | Role | What they receive |
|---|---|---|
| AKI patients | Patients with acute Kidney Injury (AKI) with clinical indication for CKRT Receives: Device: multiFlux 160 hemofilter with regional heparin anticoagulation; Device: multiFlux 160 hemofilter with RCA with regional citrate anticoagulation; Device: multiFlux 130 hemofilter with regional heparin anticoagulation; Device: multiFlux 130 hemofilter with RCA with regional citrate anticoagulation; Device: multiFlux 60 hemofilter with regional heparin anticoagulation; Device: multiFlux 60 hemofilter with RCA with regional citrate anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points
Measured: From enrollment up to 10 days
Assessment of potential electrolyte imbalances or acid base disturbances during RCA treatment
Measured: From enrollment up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mediconomics GmbH
- Responsible party
- Sponsor
- Investigators
- Christina Scharf-Janßen, PD Dr. med., Principal investigator, LMU University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679568
- Sponsor's protocol ID
- CKRT-AKI-04-EU
- Acronym
- RCA-Flux
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of CKRT Treatments With multiFlux Hemofilters Using RCA or Systemic Heparin Anticoagulation
- ClinicalTrials.gov ID
- NCT07679568
- Acronym / sponsor ID
- RCA-Flux / CKRT-AKI-04-EU
- Conditions
- Acute Kidney Injury, Renal Failure
- Keywords
- Continuous kidney replacement therapy, Regional citrate anticoagulation, Systemic heparin anticoagulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Mediconomics GmbH
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Jul 2026 (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 goal of this observational study is to assess the performance of the multiFlux hemofilterwith regional or systemic anticoagulation during CKRT treatments. The multiFlux hemofilter is a single use device within the extracorporeal blood circuit during extracorporeal blood purification treatments for acute renal replacement therapies.
Detailed description
Patients enrolled in this clinical investigation will be treated either with citrate anticoagulation in Continuous venovenous hemodialysis (CVVHD) or Continuous venovenous hemodiafiltration (CVVHDF) in post-dilution mode (RCA-post-CVVHDF) with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier)) or with heparin in any of the possible CKRT modes (pre-, post- or pre-post CVVH, CVVHD, pre-, post- or pre-post CVVHDF) for up to 10 days based on investigator´s decision (data beyond 10 days will not be collected within the study) or until withdrawal of informed consent or death.
For the study, treatment data will be documented for a maximum of 10 days.
The selection of the filter size depends on the prescription of the attending physician. The body weight limitations as shall be considered:
Mutiflux 160 ≥ 40 kg, Multiflux 130 ≥ 30 kg, Multiflux 60 ≥ 8 kg
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AKI patients | – | Device: multiFlux 160 hemofilter with regional heparin anticoagulation, Device: multiFlux 160 hemofilter with RCA with regional citrate anticoagulation, Device: multiFlux 130 hemofilter with regional heparin anticoagulation, Device: multiFlux 130 hemofilter with RCA with regional citrate anticoagulation, Device: multiFlux 60 hemofilter with regional heparin anticoagulation, Device: multiFlux 60 hemofilter with RCA with regional citrate anticoagulationPatients with acute Kidney Injury (AKI) with clinical indication for CKRT |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of critically ill patients (adults and children) requiring continuous kidney replacement therapy (CKRT).
Key inclusion criteria (14 listed)
- Informed consent signed and dated by the investigator; and
- Informed consent signed and dated by legal representative and investigator/ authorized physician.
- The minors have received the information referred to in Article 63(2) Medical Device Regulation (MDR) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children. If able, the minors have to sign the informed consent, too.
- The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator
- Body weight ≥ 8kg
Key exclusion criteria (5 listed)
- Any conditions which could interfere with the patient's ability to comply with the study
- Patient or legal representative or authorized physician during emergency situation is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
- Participation in a different interventional clinical study during the preceding 30 days
- Previous participation in the same study
- Uncontrolled bleeding and coagulation disorders
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 |
|---|---|---|
| multiFlux 160 hemofilter with regional heparin anticoagulationExtracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI) | Device | AKI patients |
| multiFlux 160 hemofilter with RCA with regional citrate anticoagulationExtracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI) | Device | AKI patients |
| multiFlux 130 hemofilter with regional heparin anticoagulationExtracorporeal blood purification with the multiFlux 130 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI) | Device | AKI patients |
| multiFlux 130 hemofilter with RCA with regional citrate anticoagulationExtracorporeal blood purification with the multiFlux130 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI) | Device | AKI patients |
| multiFlux 60 hemofilter with regional heparin anticoagulationExtracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI) | Device | AKI patients |
| multiFlux 60 hemofilter with RCA with regional citrate anticoagulationExtracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI) | Device | AKI patients |
Primary outcome
Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points
Time frame: From enrollment up to 10 days
Assessment of potential electrolyte imbalances or acid base disturbances during RCA treatment
Time frame: From enrollment up to 10 days
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 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Christina Scharf-Janßen, PD Dr. med. principal investigator
LMU University Hospital
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 and Renal Failure, run by Fresenius Medical Care Deutschland GmbH at 1 site in Germany.
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 14 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Sep 2026. 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 Germany. 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 Celina Meyer (+49 6172 268 6809, Celina.Meyer@FreseniusMedicalCare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points (time frame: From enrollment up to 10 days). The study lists 2 primary outcomes in all. 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 4 Sep 2026.