Acute Kidney InjurymultiPlusNCT05315817
Safety and Performance Evaluation of multiPlus Dialysate During CRRT
A study testing multiPlus dialysate in people with Acute Kidney Injury, run by Fresenius Medical Care Deutschland GmbH at 1 site in Germany.
Trial summary
Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6 hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration [CVVHD(F)]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- multiPlus dialysate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2022to 24 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Signed and dated informed consent form by investigator and by
- a) the study patient: if patient is able to consent
- b) the legal representative: if patient is unable to consent:
- c) an independent consultant: in case of emergency
- if c) either legal representative or study patient, whichever can be done sooner, should be informed by the investigator as soon as possible. If the informed consent has been obtained by the legal representative (b or emergency scenario) informed consent to continue the participation in the clinical investigation shall be obtained from the subject as soon as he or she is capable of giving informed consent (According to the MDR - Article 68 - Clinical investigations in emergency situations)
- Minimum age of 18 years
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- Ability to understand the nature and requirements of the study (if patient is conscious)
- Study specific:
- Body weight greater than 40 kg
- Acute Kidney Injury (AKI) with clinical indication for CVVHD/CVVHDF
- Vascular access allowing blood flow of min 50mL/min
- 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
- In case of female patients: pregnancy (negative pregnancy test for women below 55 years) or lactation period
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- SARS-CoV 2 positive
- Study specific
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- Hyperphosphataemia (>4.5 mg/dL)
- Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II)
- Uncontrolled bleeding and coagulation disorders
- Decision to limit therapeutic interventions
- Advanced malignancy (not including myeloma)
- Dementia (if definitely not an acute confusional state from uraemia or other acute illness)
- Advanced cirrhosis with encephalopathy in the absence of possible liver transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6 hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration [CVVHD(F)].
multiPlus is a phosphate-containing dialysis solution for the use in continuous renal replacement therapy (CRRT) during acute kidney injury (AKI).
- Conditions
- Acute Kidney Injury
- Being tested
- multiPlus dialysate
- Keywords
- Renal replacement therapy, Acute kidney injury, Haemodialysis, Haemodiafiltration
- 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.
multiPlus dialysateDevice
Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.
| Study group | Role | What they receive |
|---|---|---|
| multiPlus dialysate | Experimental | Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate. Receives: Device: multiPlus dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine removal
The primary variable of this clinical investigation is serum creatinine removal (arterial pre-filter sample taking) assessed 6 hours (360 min) after start of CVVHD(F).
Measured: 360 min after start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start31 May 2022
- Primary completion28 Oct 2022
- Study completion24 Jan 2023
Why it stopped: Internal reasons
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-comparative, multi-centre, open-label, interventional, post market clinical follow-up (PMCF) study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Responsible party
- Sponsor
- Investigators
- Michael A. Borger, Prof Dr, Principal investigator, Helios Health Institute GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315817
- Sponsor's protocol ID
- CRRT-CVVHD(F)/MP-01-D
- Acronym
- multiPlus
- Status last verified
- Dec 2023
- First submitted
- 30 Mar 2022
- Last updated
- 9 Jan 2024
- 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 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation of multiPlus Dialysate During CRRT
- ClinicalTrials.gov ID
- NCT05315817
- Acronym / sponsor ID
- multiPlus / CRRT-CVVHD(F)/MP-01-D
- Conditions
- Acute Kidney Injury
- Keywords
- Renal replacement therapy, Acute kidney injury, Haemodialysis, Haemodiafiltration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal reasons
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Study start
- 31 May 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 7 Apr 2022 (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.
Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6 hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration [CVVHD(F)].
multiPlus is a phosphate-containing dialysis solution for the use in continuous renal replacement therapy (CRRT) during acute kidney injury (AKI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-comparative, multi-centre, open-label, interventional, post market clinical follow-up (PMCF) study
| Arm | Type | Receives |
|---|---|---|
| multiPlus dialysate | Experimental | Device: multiPlus dialysateTreatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed and dated informed consent form by investigator and by
- if c) either legal representative or study patient, whichever can be done sooner, should be informed by the investigator as soon as possible. If the informed consent has been obtained by the legal representative (b or emergency scenario) informed consent to continue the participation in the clinical investigation shall be obtained from the subject as soon as he or she is capable of giving informed consent (According to the MDR - Article 68 - Clinical investigations in emergency situations)
- Minimum age of 18 years
- Ability to understand the nature and requirements of the study (if patient is conscious)
- Body weight greater than 40 kg
Key exclusion criteria (13 listed)
- Any conditions which could interfere with the patient's ability to comply with the study
- In case of female patients: pregnancy (negative pregnancy test for women below 55 years) or lactation period
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- SARS-CoV 2 positive
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 |
|---|---|---|
| multiPlus dialysateTreatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate. | Device | multiPlus dialysate |
Primary outcome
Serum creatinine removal
Time frame: 360 min after start
The primary variable of this clinical investigation is serum creatinine removal (arterial pre-filter sample taking) assessed 6 hours (360 min) after start of CVVHD(F).
Results and safety
The study was stopped early (reason given: Internal reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- 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. This study is not recruiting at the moment.
Michael A. Borger, Prof Dr principal investigator
Helios Health Institute GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multiPlus dialysate in people with Acute Kidney Injury, 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 12 inclusion and 13 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: stopped early, as of the sponsor's last update on 9 Jan 2024. 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?
The study was stopped early (reason given: Internal reasons). Results are not available in the source record.
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?
Serum creatinine removal (time frame: 360 min after start). 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 2024.