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Not yet recruitingNCT07679568RCA-FluxUpdated Sep 4, 2026

Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation

An observational study in Acute Kidney Injury and Renal Failure, sponsored by Fresenius Medical Care Deutschland GmbH. Not yet recruiting at 1 site in Germany. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Fresenius Medical Care Deutschland GmbH (part of Fresenius Medical Care) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
62
Ages
1 Year and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Acute Kidney Injury
  • Renal Failure

Keywords

  • Continuous kidney replacement therapy
  • Regional citrate anticoagulation
  • Systemic heparin anticoagulation
03

In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's planned enrollment of 62 is below the median of 160 across 814 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Fresenius Medical Care Deutschland GmbH is the lead sponsor of 36 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population consists of critically ill patients (adults and children) requiring continuous kidney replacement therapy (CKRT).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

General:

Patients ≥ 18 years:

  • signed and dated by the investigator; and

    1. if patient is able to give consent: by the study patient
    2. if patients unable to give consent: by the legal representative/spouse according to § 1358 BGB or
    3. if an emergency situation is determined: by an independent consultant physician.

      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 greater than 3 days

Exclusion criteria

Exclusion Criteria:

  • 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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
62 participants (estimated)
Patient registry
No

Groups and cohorts

  • AKI patients

    Patients with acute Kidney Injury (AKI) with clinical indication for CKRT

    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

Interventions

  • DevicemultiFlux 160 hemofilter with regional heparin anticoagulation

    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)

  • DevicemultiFlux 160 hemofilter with RCA with regional citrate anticoagulation

    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)

  • DevicemultiFlux 130 hemofilter with regional heparin anticoagulation

    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)

  • DevicemultiFlux 130 hemofilter with RCA with regional citrate anticoagulation

    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)

  • DevicemultiFlux 60 hemofilter with regional heparin anticoagulation

    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)

  • DevicemultiFlux 60 hemofilter with RCA with regional citrate anticoagulation

    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)

06

What researchers measure

Primary outcomes

  1. Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points

    Time frame: From enrollment up to 10 days

  2. Assessment of potential electrolyte imbalances or acid base disturbances during RCA treatment

    Time frame: From enrollment up to 10 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.

Of 364 observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2026
First posted
Jul 1, 2026
StartEst.
Nov 2026
Primary completionEst.
Oct 2027
CompletionEst.
Dec 2027
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07679568
Collaborators
Mediconomics GmbH
Responsible party
Sponsor
First posted
Jul 1, 2026
Start date
Nov 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Celina Meyer
Contact
Celina.Meyer@FreseniusMedicalCare.com
+49 6172 268 6809
Anja Derlet-Savoia, Dr.
Contact
Anja.Derlet@freseniusmedicalcare.com
+49 6172 268 6648
Christina Scharf-Janßen, PD Dr. med.
principal investigator · LMU University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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