Acute Kidney InjuryPhase 2CiPRICSNCT02397213
Ciclosporin to Protect Renal Function In Cardiac Surgery
A Phase 2 study testing Ciclosporin in people with Acute Kidney Injury, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the potential of ciclosporin in reducing risk and degree of acute kidney injury after cardiac surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Ciclosporin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2015to Sep 2016
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Non-emergent CABG
- Written informed consent to participate
- Preoperative CyC eGFR or MDRD eGFR is 90-15.
Who cannot join
- Uncontrolled hypertension
- Hypersensitivity to ciclosporin or any of the excipients of the lipid emulsion, including egg-, soya- or peanut protein
- Pregnancy or fertile woman
- Ciclosporin treatment within 4 weeks
- Ongoing malignancy, ongoing immunosuppressive treatment, severe hepatic dysfunction, dialysis or severe infection
- Ongoing medication with dabigatran, aliskiren, bosentan, stiripentol, glibenclamid, St John's worth, or
- Off-pump surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ciclosporin to Protect Renal Function In Cardiac Surgery: CiPRICS A Phase II Double Blind Randomized Placebo Controlled Study
The purpose of this study is to evaluate the potential of ciclosporin in reducing risk and degree of acute kidney injury after cardiac surgery.
Read the detailed description
Acute kidney injury (AKI) is a common complication after cardiac surgery and is associated with decreased long-term survival. The mechanism for inducing acute kidney injury is unknown but ischaemia-reperfusion injury is indicated to be a part of the cause.
Animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of ciclosporin in ischaemia-reperfusion injury in the kidney. The major mechanism is thought to be inhibition of the reperfusion triggered opening of the mitochondrial permeability transition pore (mPTP), responsible for reperfusion-induced necrosis. During cardiac surgery, the period of extracorporeal circulation (ECC) changes the perfusion through the kidney. Return to normal perfusion with a beating heart has similarities with reperfusion following ischemia.
Administration of ciclosporin in conjunction with percutaneous coronary intervention (PCI), heart surgery and traumatic brain injury (TBI) in humans has shown to be safe with no direct side-effects.
The investigators therefore hypothesize that a preconditioning effect of ciclosporin before coronary artery bypass grafting (CABG) can reduce the level of renal dysfunction after this type of cardiac surgery.
- Conditions
- Acute Kidney Injury
- Being tested
- Ciclosporin, Placebo
- Keywords
- Ciclosporin, Acute Kidney injury, Cardiac surgery, Ischemia, Safety, Cystatin C
- Medical subject headings
- Acute Kidney Injury, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclosporinDrug
Also called CicloMulsion® ATC-code: CO1EB
Single dose of CicloMulsion® 5 mg/ml, 2.5 mg/kg (=0.5 ml/kg) as intravenous injection preoperatively after anesthesia induction.
PlaceboDrug
All components of the CicloMulsion® emulsion except ciclosporin: soybean oil (refined), triglycerides (medium-chain), egg lecithin, glycerol, oleic acid, sodium hydroxide and water for injection (=0.5 ml/kg).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | All components of the CicloMulsion® emulsion except ciclosporin: soybean oil (refined), triglycerides (medium-chain), egg lecithin, glycerol, oleic acid, sodium hydroxide and water for injection (=0.5 ml/kg). Receives: Drug: Placebo |
| Ciclosporin | Active comparator | Single dose of CicloMulsion® 5 mg/ml, 2.5 mg/kg (=0.5 ml/kg) as intravenous injection. Receives: Drug: Ciclosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ciclosporin to Protect Renal function In Cardiac Surgery.
Relative P-CyC change from day -1 to day 3.
Measured: up to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroVive Pharmaceutical AB
- Responsible party
- Sponsor
- Investigators
- Henrik Bjursten, Md, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397213
- Sponsor's protocol ID
- 2014-004610-29
- Other IDs
- 2014
- Acronym
- CiPRICS
- Status last verified
- Oct 2016
- First submitted
- 12 Mar 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ederoth P, Grins E, Dardashti A, Bronden B, Metzsch C, Erdling A, Nozohoor S, Mokhtari A, Hansson MJ, Elmer E, Algotsson L, Jovinge S, Bjursten H. Ciclosporin to Protect Renal function In Cardiac Surgery (CiPRICS): a study protocol for a double-blind, randomised, placebo-controlled, proof-of-concept study. BMJ Open. 2016 Dec 15;6(12):e012299. doi: 10.1136/bmjopen-2016-012299.
PubMed 27979834
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciclosporin to Protect Renal Function In Cardiac Surgery: CiPRICS A Phase II Double Blind Randomized Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02397213
- Acronym / sponsor ID
- CiPRICS / 2014-004610-29
- Conditions
- Acute Kidney Injury
- Keywords
- Ciclosporin, Acute Kidney injury, Cardiac surgery, Ischemia, Safety, Cystatin C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- NeuroVive Pharmaceutical AB
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Mar 2015 (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.
The purpose of this study is to evaluate the potential of ciclosporin in reducing risk and degree of acute kidney injury after cardiac surgery.
Detailed description
Acute kidney injury (AKI) is a common complication after cardiac surgery and is associated with decreased long-term survival. The mechanism for inducing acute kidney injury is unknown but ischaemia-reperfusion injury is indicated to be a part of the cause.
Animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of ciclosporin in ischaemia-reperfusion injury in the kidney. The major mechanism is thought to be inhibition of the reperfusion triggered opening of the mitochondrial permeability transition pore (mPTP), responsible for reperfusion-induced necrosis. During cardiac surgery, the period of extracorporeal circulation (ECC) changes the perfusion through the kidney. Return to normal perfusion with a beating heart has similarities with reperfusion following ischemia.
Administration of ciclosporin in conjunction with percutaneous coronary intervention (PCI), heart surgery and traumatic brain injury (TBI) in humans has shown to be safe with no direct side-effects.
The investigators therefore hypothesize that a preconditioning effect of ciclosporin before coronary artery bypass grafting (CABG) can reduce the level of renal dysfunction after this type of cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAll components of the CicloMulsion® emulsion except ciclosporin: soybean oil (refined), triglycerides (medium-chain), egg lecithin, glycerol, oleic acid, sodium hydroxide and water for injection (=0.5 ml/kg). |
| Ciclosporin | Active comparator | Drug: CiclosporinSingle dose of CicloMulsion® 5 mg/ml, 2.5 mg/kg (=0.5 ml/kg) as intravenous injection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Non-emergent CABG
- Written informed consent to participate
- Preoperative CyC eGFR or MDRD eGFR is 90-15.
Key exclusion criteria (7 listed)
- Uncontrolled hypertension
- Hypersensitivity to ciclosporin or any of the excipients of the lipid emulsion, including egg-, soya- or peanut protein
- Pregnancy or fertile woman
- Ciclosporin treatment within 4 weeks
- Ongoing malignancy, ongoing immunosuppressive treatment, severe hepatic dysfunction, dialysis or severe infection
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 |
|---|---|---|
| CiclosporinAlso: CicloMulsion® ATC-code: CO1EBSingle dose of CicloMulsion® 5 mg/ml, 2.5 mg/kg (=0.5 ml/kg) as intravenous injection preoperatively after anesthesia induction. | Drug | Ciclosporin |
| PlaceboAll components of the CicloMulsion® emulsion except ciclosporin: soybean oil (refined), triglycerides (medium-chain), egg lecithin, glycerol, oleic acid, sodium hydroxide and water for injection (=0.5 ml/kg). | Drug | Placebo |
Primary outcome
Ciclosporin to Protect Renal function In Cardiac Surgery.
Time frame: up to day 3
Relative P-CyC change from day -1 to day 3.
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 13 Oct 2016.
- Derived from this study: PubMed 27979834Ederoth P, Grins E, Dardashti A, Bronden B, Metzsch C, Erdling A, Nozohoor S, Mokhtari A, Hansson MJ, Elmer E, Algotsson L, Jovinge S, Bjursten H. Ciclosporin to Protect Renal function In Cardiac Surgery (CiPRICS): a study protocol for a double-blind, randomised, placebo-controlled, proof-of-concept study. BMJ Open. 2016 Dec 15;6(12):e012299. doi: 10.1136/bmjopen-2016-012299.
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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.
Henrik Bjursten, Md, PhD principal investigator
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciclosporin in people with Acute Kidney Injury, run by Region Skane at 1 site in Sweden.
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 3 inclusion and 7 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 13 Oct 2016. 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 Sweden. 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 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.
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?
Ciclosporin to Protect Renal function In Cardiac Surgery. (time frame: up to day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02397213, which also lists 1 linked publication.
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 13 Oct 2016.