Liver TransplantationPhase 2CILTNCT00890253
Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation
A Phase 2 study testing Basiliximab (Simulect), Myfortic and everolimus in people with Liver Transplantation and Chronic Renal Insufficiency, run by Armin Goralczyk at 1 site in Germany.
Trial summary
A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti-body (basiliximab), mycophenolic acid (MPA), and mammalian target of rapamycin (mTOR) - inhibition with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Chronic Renal Insufficiency
- What is being tested?
- Basiliximab (Simulect), Myfortic and everolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jan 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary liver transplantation.
- Patients older than 18 years.
- Patients with a hepatorenal syndrome.
- Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation.
- eGFR < 50 ml/min at the time point of transplantation.
- Serum creatinine levels > 1.5 mg/dL at the time-point of transplantation.
Who cannot join
- Patients with pre-transplant renal replacement therapy > 14 days.
- Patients with a reason for renal impairment other than a hepatorenal syndrome.
- Patients with a known hypersensitivity to mTOR-inhibitors.
- Patients with a known hypersensitivity to mycophenolate acid.
- Patients with a known hypersensitivity to anti CD 25-monoclonal antibodies.
- Patients with platelets < 50.000/nl prior to initiation of therapy with mTOR inhibition.
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- Patients with triglycerides > 350 mg/dl and cholesterol > 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition.
- Severe systemic infections and wound-healing disturbances.
- Multiple organ graft recipients.
- Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with everolimus.
- Pregnant women will not be included in the study.
- Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
- Patients under guardianship (e.g., individuals who are not able to freely give their informed consent).
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Goettingen
Göttingen, 37099
Armin D Goralczyk, Dr., +49 551 398490, agoralczyk@med.uni-goettingen.de
Aiman Obed, PD Dr., +49 551 39 12296, aobed@chirurgie-goettingen.de
About this study
Official title: A Therapeutic Exploratory Study to Determine the Efficacy and Safety of Calcineurin-Inhibitor-Free De-novo Immunosuppression After Liver Transplantation
A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti-body (basiliximab), mycophenolic acid (MPA), and mammalian target of rapamycin (mTOR) - inhibition with everolimus to determine its safety and to investigate the preliminary efficacy in patients with impaired renal function at the time-point of liver transplantation (OLT) with regards to the incidence of steroid resistant acute rejection within the first 30 days after liver transplantation.
- Conditions
- Liver Transplantation, Chronic Renal Insufficiency
- Being tested
- Basiliximab (Simulect), Myfortic, everolimus, Prednisolone
- Keywords
- Renal impairment, Liver transplantation, Chronic Renal Insufficiency
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basiliximab (Simulect)Drug
Also called Basiliximab: Simulect
20 mg basiliximab (Simulect) iv on day 0 and 4 after OLT
MyforticDrug
Also called Enteric-coated mycophenolate sodium: EC-MPS, Myfortic
1080 mg q12 EC-MPS (Myfortic) po starting within 24h after OLT
everolimusDrug
Also called Certican
1 mg q12 everolimus (Certican) po starting on 10th post-operative day
PrednisoloneDrug
Also called Prednisone
Prednisolone 1mg per kg body weight starting within 24 hours after transplantation. Then q24 but with reduction by 5 mg every 48 hours until maintenance dose of 7.5 mg
| Study group | Role | What they receive |
|---|---|---|
| CNI-free Immunosuppression | Experimental | Immunosuppression after OLT including basiliximab, enteric-coated mycophenolate sodium (EC-MPS), and everolimus. Receives: Drug: Basiliximab (Simulect); Drug: Myfortic; Drug: everolimus; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steroid resistant rejection
Measured: 30 days
Secondary outcomes (6)
Steroid resistant rejection
Measured: 1 year
Liver function
Measured: 1 year
Calculated glomerular filtration rate
Measured: 1 year
Patient survival
Measured: 1 year
Number of days on renal replacement therapy
Measured: 1 year
Graft survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2012 (estimated)
- Study completionJan 2013 (estimated)
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 Liver TransplantationStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armin Goralczyk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Armin Goralczyk, University Medical Center Goettingen
- Investigators
- Aiman Obed, PD Dr., Study director, University Medical Center GoettingenArmin D Goralczyk, Dr., Principal investigator, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890253
- Sponsor's protocol ID
- CILT08
- Acronym
- CILT
- Status last verified
- Jan 2010
- First submitted
- 28 Apr 2009
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goralczyk AD, Schnitzbauer A, Tsui TY, Ramadori G, Lorf T, Obed A. A therapeutic exploratory study to determine the efficacy and safety of calcineurin-inhibitor-free de-novo immunosuppression after liver transplantation: CILT. BMC Surg. 2010 Apr 9;10:15. doi: 10.1186/1471-2482-10-15.
PubMed 20380712
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Therapeutic Exploratory Study to Determine the Efficacy and Safety of Calcineurin-Inhibitor-Free De-novo Immunosuppression After Liver Transplantation
- ClinicalTrials.gov ID
- NCT00890253
- Acronym / sponsor ID
- CILT / CILT08
- Conditions
- Liver Transplantation, Chronic Renal Insufficiency
- Keywords
- Renal impairment, Liver transplantation, Chronic Renal Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Armin GoralczykUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 29 Apr 2009 (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.
A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti-body (basiliximab), mycophenolic acid (MPA), and mammalian target of rapamycin (mTOR) - inhibition with everolimus to determine its safety and to investigate the preliminary efficacy in patients with impaired renal function at the time-point of liver transplantation (OLT) with regards to the incidence of steroid resistant acute rejection within the first 30 days after liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CNI-free Immunosuppression | Experimental | Drug: Basiliximab (Simulect), Drug: Myfortic, Drug: everolimus, Drug: PrednisoloneImmunosuppression after OLT including basiliximab, enteric-coated mycophenolate sodium (EC-MPS), and everolimus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing primary liver transplantation.
- Patients older than 18 years.
- Patients with a hepatorenal syndrome.
- Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation.
- eGFR < 50 ml/min at the time point of transplantation.
Key exclusion criteria (13 listed)
- Patients with pre-transplant renal replacement therapy > 14 days.
- Patients with a reason for renal impairment other than a hepatorenal syndrome.
- Patients with a known hypersensitivity to mTOR-inhibitors.
- Patients with a known hypersensitivity to mycophenolate acid.
- Patients with a known hypersensitivity to anti CD 25-monoclonal antibodies.
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 |
|---|---|---|
| Basiliximab (Simulect)Also: Basiliximab: Simulect20 mg basiliximab (Simulect) iv on day 0 and 4 after OLT | Drug | CNI-free Immunosuppression |
| MyforticAlso: Enteric-coated mycophenolate sodium: EC-MPS, Myfortic1080 mg q12 EC-MPS (Myfortic) po starting within 24h after OLT | Drug | CNI-free Immunosuppression |
| everolimusAlso: Certican1 mg q12 everolimus (Certican) po starting on 10th post-operative day | Drug | CNI-free Immunosuppression |
| PrednisoloneAlso: PrednisonePrednisolone 1mg per kg body weight starting within 24 hours after transplantation. Then q24 but with reduction by 5 mg every 48 hours until maintenance dose of 7.5 mg | Drug | CNI-free Immunosuppression |
Primary outcome
Steroid resistant rejection
Time frame: 30 days
6 secondary outcomes
Steroid resistant rejection
Time frame: 1 year
Liver function
Time frame: 1 year
Calculated glomerular filtration rate
Time frame: 1 year
Patient survival
Time frame: 1 year
Number of days on renal replacement therapy
Time frame: 1 year
Graft survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2011.
- Derived from this study: PubMed 20380712Goralczyk AD, Schnitzbauer A, Tsui TY, Ramadori G, Lorf T, Obed A. A therapeutic exploratory study to determine the efficacy and safety of calcineurin-inhibitor-free de-novo immunosuppression after liver transplantation: CILT. BMC Surg. 2010 Apr 9;10:15. doi: 10.1186/1471-2482-10-15.
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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.
Aiman Obed, PD Dr. study director
University Medical Center Goettingen
Armin D Goralczyk, Dr. principal investigator
University Medical Center Goettingen
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 Basiliximab (Simulect), Myfortic and everolimus in people with Liver Transplantation and Chronic Renal Insufficiency, run by Armin Goralczyk 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 6 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: status not confirmed, as of the sponsor's last update on 15 Sep 2011. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aiman Obed, Prof. Dr. (+49 551 3912296, aobed@chirurgie-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid resistant rejection (time frame: 30 days). 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 NCT00890253, 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 15 Sep 2011.