Acute Kidney InjuryPhase 2/3LAKISNCT01720030
Levosimendan in Acute Kidney Injury Study
A Phase 2/3 study testing Levosimendan and Conventional therapy in people with Acute Kidney Injury, run by VieCuri Medical Centre at 1 site in Netherlands.
Trial summary
We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients. 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?
- Levosimendan and Conventional therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to Oct 2017
- Phase
- Phase 2/3
- 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
- Clinically diagnosed adult patients with AKI
Who cannot join
- Failure to obtain written consent to participate from patient or legal representative (by deferred consent)
- Patients entering the ICU for post-operative observation with an estimated length of stay less than 24 hrs.
- Moribund patients
- Patients under the age of 18
- Pregnancy
- Patients suffering from pre-existing renal failure (elevated NGAL values without apparent rise in creatinine values)
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- Renal replacement therapy initiated before admission due to Chronic Kidney Disease
- Hypersensitivity to levosimendan experienced by previous treatments
- Severe hypotension and tachycardia
- Significant mechanical obstruction affecting ventricular filling or outflow or both.
- Severe hepatic impairment (ALAT/ASAT>400U/L)
- Patients will be excluded if the treating physician judges that study participation is undesirable for medical, medical-ethical or other reasons
- Known history of Torsades de Pointes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Monocenter, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Levosimendan in Intensive Care Patients With Acute Kidney Injury
We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.
Read the detailed description
The purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.
- Conditions
- Acute Kidney Injury
- Being tested
- Levosimendan, Conventional therapy
- Keywords
- Renal, Acute Kidney Injury, AKI, Levosimendan, Simdax, Renal perfusion, Mortality, Renal flow
- 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.
LevosimendanDrug
Also called Simdax (R)
Verum therapy
Conventional therapyDrug
Also called Standard care plus placebo comparator
Placebo therapy to safeguard blinding
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Placebo comparator | Standard of care as protocolized locally Receives: Drug: Conventional therapy |
| Levosimendan | Experimental | The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI. Receives: Drug: Levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in renal function
Daily analysis of kidney function expressed in endogenous creatinine clearance
Measured: Baseline and every 24 hours until end ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startSep 2016
- Primary completionOct 2017
- Study completionOct 2017
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- VieCuri Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Sponsor
- Investigators
- Jos Le Noble, MD PhD, Principal investigator, VieCuri Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720030
- Sponsor's protocol ID
- Levosimendan in AKI Study
- Acronym
- LAKIS
- Status last verified
- Aug 2026
- First submitted
- 3 Oct 2012
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Monocenter, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Levosimendan in Intensive Care Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT01720030
- Acronym / sponsor ID
- LAKIS / Levosimendan in AKI Study
- Conditions
- Acute Kidney Injury
- Keywords
- Renal, Acute Kidney Injury, AKI, Levosimendan, Simdax, Renal perfusion, Mortality, Renal flow
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- VieCuri Medical CentreUniversity, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 1 Nov 2012 (estimated)
- 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.
We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.
Detailed description
The purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | Placebo comparator | Drug: Conventional therapyStandard of care as protocolized locally |
| Levosimendan | Experimental | Drug: LevosimendanThe experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically diagnosed adult patients with AKI
Key exclusion criteria (13 listed)
- Failure to obtain written consent to participate from patient or legal representative (by deferred consent)
- Patients entering the ICU for post-operative observation with an estimated length of stay less than 24 hrs.
- Moribund patients
- Patients under the age of 18
- Pregnancy
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 |
|---|---|---|
| LevosimendanAlso: Simdax (R)Verum therapy | Drug | Levosimendan |
| Conventional therapyAlso: Standard care plus placebo comparatorPlacebo therapy to safeguard blinding | Drug | Conventional therapy |
Primary outcome
Change in renal function
Time frame: Baseline and every 24 hours until end ICU stay
Daily analysis of kidney function expressed in endogenous creatinine clearance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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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.
Jos Le Noble, MD PhD principal investigator
VieCuri Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Levosimendan and Conventional therapy in people with Acute Kidney Injury, run by VieCuri Medical Centre at 1 site in Netherlands.
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 1 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: finished, as of the sponsor's last update on 21 Aug 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in renal function (time frame: Baseline and every 24 hours until end ICU stay). 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 21 Aug 2026.