NCT02397213

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

March 12, 2015

Last Update Submit

October 12, 2016

Conditions

Acute Kidney Injury

Keywords

CiclosporinAcute Kidney injuryCardiac surgeryIschemiaSafetyCystatin C

Outcome Measures

Primary Outcomes (1)

  • Ciclosporin to Protect Renal function In Cardiac Surgery.

    Relative P-CyC change from day -1 to day 3.

    up to day 3

Study Arms (2)

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).

Drug: Placebo

Ciclosporin

ACTIVE COMPARATOR

Single dose of CicloMulsion® 5 mg/ml, 2.5 mg/kg (=0.5 ml/kg) as intravenous injection.

Drug: Ciclosporin

Interventions

CiclosporinDRUG

Single dose of CicloMulsion® 5 mg/ml, 2.5 mg/kg (=0.5 ml/kg) as intravenous injection preoperatively after anesthesia induction.

Also known as: CicloMulsion® ATC-code: CO1EB
Ciclosporin
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).

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Non-emergent CABG
  • Written informed consent to participate
  • Preoperative CyC eGFR or MDRD eGFR is 90-15.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skane University Hospital

Lund, 22185, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 27979834DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryIschemia

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Henrik Bjursten, Md, PhD

    Skane University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 24, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

SE(1)