Liver TransplantationPhase 4NCT02123108
Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation
A Phase 4 study testing Basiliximab, Tacrolimus and Mycophenolic Acid in people with Liver Transplantation, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This is an investigator initiated study at the University of California, Los Angeles (UCLA) funded by Novartis looking at using a combination of immunosuppressive drugs in liver transplant patients that are at risk of developing kidney problems. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Basiliximab, Tacrolimus and Mycophenolic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- >18 years old
- Undergoing first or second OLT
- MELD (model for end-stage liver disease) score >25
- Serum creatinine > 1.5 or ongoing hemodialysis for less than 4 weeks at the time of transplant
- Able and agreeable to conform to requirements of the study
- Patients or proxy must give written informed consent before any assessment is performed.
Who cannot join
- <18 years old
- Serum creatinine <1.5
- MELD Score < 25
- Ongoing hemodialysis for 4 or more weeks (those patients become eligible for renal transplants at that point per UCLA practice).
- Receiving OKT3 (Muromonab-CD3), ATG (Antithymocyte Globulin), or IVIG (Intravenous Immunoglobulin Therapy) therapy around time of transplant
- Participating in another clinical research study involving the evaluation of another investigational drug or device
- Prior documented allergy to any of the study medications
- Active Fungal infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
About this study
Official title: Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA, Versus Standard Dose Tacrolimus, ECMPA Plus Corticosteroids in Patients Undergoing Liver Transplant
This is an investigator initiated study at the University of California, Los Angeles (UCLA) funded by Novartis looking at using a combination of immunosuppressive drugs in liver transplant patients that are at risk of developing kidney problems. Kidney problems following liver transplants is the most problematic issue facing liver transplant patients today.
This study will generate information in this area of high unmet medical need utilizing basiliximab and Myfortic and using a reduced dose of tacrolimus, one of the current standard of care medications, after kidney function has normalized.
Read the detailed description
Since basiliximab works on the same receptor system as tacrolimus and has not been shown to cause significant adverse effects, such as nephrotoxicity or the cytokine release syndrome, the investigators are proposing induction therapy with basiliximab in liver transplant patients with concomitant preoperative renal dysfunction. This will combat acute rejection and allow the delay of tacrolimus therapy until post-operative day #7. The delay in tacrolimus therapy should allow renal function to improve and reduce the chance of continued renal dysfunction. Also, the addition of basiliximab to the immunosuppressive regimen should allow for a reduction in tacrolimus dose (normal tacrolimus concentrations at UCLA are 7-10ng/mL. Our goal will be 3-5ng/mL) in the immediate post-transplant period thereby reducing the chance of acute and long-term efficacy-limiting adverse effects associated with the tacrolimus while maintaining adequate immunosuppression to reduce acute rejection episodes. This would be the most convincing prospective randomized study utilizing basiliximab as a renal sparing agent in liver transplantation.
Objectives Primary objectives
- To evaluate renal recovery/ function following OLT in patients undergoing orthotopic liver transplant at 6 and 12 months post-transplant.
Secondary objectives (comparing the two treatment arms)
- To determine the tolerability and adverse event profile during the first year post-transplant.
- To determine incidence and severity acute rejection episodes
- To determine the incidence of death and/or graft failure within the first year post-transplant
Study design The study is a single center prospective randomized trial wherein the investigators will have two groups. Patients will be screened and eligible patients will be enrolled pre-transplant. Patients will then be randomized at time of transplant to either the control or treatment arm. Post transplant laboratory data (chemistry, tacrolimus level and liver function tests) will be collected on a daily basis. For the duration of the patients' hospital stay (average 2-3 weeks). This will provide the early data set for early post operative results. Patients will subsequently be followed on a weekly outpatient basis upon discharge as per protocol. During these visits, laboratory data (chemistry, tacrolimus level and liver function tests) are also collected and will provide the continued flow of data for our follow up analysis. Any evidence of rejection will prompt treatment with rescue therapy and if necessary disenrollment from the study.
- Conditions
- Liver Transplantation
- Being tested
- Basiliximab, Tacrolimus, Mycophenolic Acid
- Keywords
- Simulect, Myfortic, Orthotopic liver transplantation (OLT), Renal Dysfunction
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasiliximabDrug
Also called Simulect
Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4
TacrolimusDrug
Also called Prograf
Day #7 post-transplant or when serum creatinine (SCr) < 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL
TacrolimusDrug
Also called Prograf
Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL
Mycophenolic AcidDrug
Also called Myfortic, Mycophenolate sodium
Enteric coated mycophenolic acid 360-720 mg po bid
| Study group | Role | What they receive |
|---|---|---|
| Basiliximab | Experimental | Tacrolimus with Basiliximab induction Receives: Drug: Basiliximab; Drug: Tacrolimus; Drug: Mycophenolic Acid |
| Tacrolimus Group | Active comparator | Tacrolimus (without basiliximab induction); standard of care group Receives: Drug: Tacrolimus; Drug: Mycophenolic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Recovery/ Function
Number of participants who experienced dialysis independence or improvement based upon kidney function labs as a measure of renal recovery/ function following OLT in patients after undergoing orthotopic liver transplant
Measured: 12 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startJan 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Fady M Kaldas, M.D., F.A.C.S., University of California, Los Angeles
- Investigators
- Fady M Kaldas, MD, Principal investigator, UCLA Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123108
- Sponsor's protocol ID
- UCLA: CCHI621AUS17T
- Status last verified
- Sep 2022
- First submitted
- 24 Feb 2014
- Last updated
- 29 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ramirez CB, Marino IR. The role of basiliximab induction therapy in organ transplantation. Expert Opin Biol Ther. 2007 Jan;7(1):137-48. doi: 10.1517/14712598.7.1.137.
PubMed 17150025Katari SR, Magnone M, Shapiro R, Jordan M, Scantlebury V, Vivas C, Gritsch A, McCauley J, Starzl T, Demetris AJ, Randhawa PS. Clinical features of acute reversible tacrolimus (FK 506) nephrotoxicity in kidney transplant recipients. Clin Transplant. 1997 Jun;11(3):237-42.
PubMed 9193849Rimola A, Gavaler JS, Schade RR, el-Lankany S, Starzl TE, Van Thiel DH. Effects of renal impairment on liver transplantation. Gastroenterology. 1987 Jul;93(1):148-56. doi: 10.1016/0016-5085(87)90327-1.
PubMed 3556303Klintmalm GB, Gonwa TA. Nephrotoxicity associated with cyclosporine and FK506. Liver Transpl Surg. 1995 Sep;1(5 Suppl 1):11-9.
PubMed 9346596Guckelberger O, Bechstein WO, Neuhaus R, Luesebrink R, Lemmens HP, Kratschmer B, Jonas S, Neuhaus PL. Cardiovascular risk factors in long-term follow-up after orthotopic liver transplantation. Clin Transplant. 1997 Feb;11(1):60-5.
PubMed 9067697Neuhaus P, Clavien PA, Kittur D, Salizzoni M, Rimola A, Abeywickrama K, Ortmann E, Chodoff L, Hall M, Korn A, Nashan B; CHIC 304 International Liver Study Group. Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: results from a double-blind randomized placebo-controlled trial. Liver Transpl. 2002 Feb;8(2):132-42. doi: 10.1053/jlts.2002.30302.
PubMed 11862589Calmus Y, Scheele JR, Gonzalez-Pinto I, Jaurrieta EJ, Klar E, Pageaux GP, Scudamore CH, Cuervas-Mons V, Metselaar HJ, Prestele H, Girault D. Immunoprophylaxis with basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, in combination with azathioprine-containing triple therapy in liver transplant recipients. Liver Transpl. 2002 Feb;8(2):123-31. doi: 10.1053/jlts.2002.30882.
PubMed 11862588Onrust SV, Wiseman LR. Basiliximab. Drugs. 1999 Feb;57(2):207-13; discussion 214. doi: 10.2165/00003495-199957020-00006.
PubMed 10188761Cherqui D, Duvoux C, Charlotte F, Humeres R, Lauzet JY, Metreau JM, Salvat A, Rotman N, Julien M, Fagniez PL, et al. [Value of a powerful initial immunosuppression after liver transplantation. Prospective study of 60 cases]. Gastroenterol Clin Biol. 1994;18(2):115-22. French.
PubMed 8013792Berard JL, Velez RL, Freeman RB, Tsunoda SM. A review of interleukin-2 receptor antagonists in solid organ transplantation. Pharmacotherapy. 1999 Oct;19(10):1127-37. doi: 10.1592/phco.19.15.1127.30582.
PubMed 10512062
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA, Versus Standard Dose Tacrolimus, ECMPA Plus Corticosteroids in Patients Undergoing Liver Transplant
- ClinicalTrials.gov ID
- NCT02123108
- Acronym / sponsor ID
- UCLA: CCHI621AUS17T
- Conditions
- Liver Transplantation
- Keywords
- Simulect, Myfortic, Orthotopic liver transplantation (OLT), Renal Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Posted 29 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator initiated study at the University of California, Los Angeles (UCLA) funded by Novartis looking at using a combination of immunosuppressive drugs in liver transplant patients that are at risk of developing kidney problems. Kidney problems following liver transplants is the most problematic issue facing liver transplant patients today.
This study will generate information in this area of high unmet medical need utilizing basiliximab and Myfortic and using a reduced dose of tacrolimus, one of the current standard of care medications, after kidney function has normalized.
Detailed description
Since basiliximab works on the same receptor system as tacrolimus and has not been shown to cause significant adverse effects, such as nephrotoxicity or the cytokine release syndrome, the investigators are proposing induction therapy with basiliximab in liver transplant patients with concomitant preoperative renal dysfunction. This will combat acute rejection and allow the delay of tacrolimus therapy until post-operative day #7. The delay in tacrolimus therapy should allow renal function to improve and reduce the chance of continued renal dysfunction. Also, the addition of basiliximab to the immunosuppressive regimen should allow for a reduction in tacrolimus dose (normal tacrolimus concentrations at UCLA are 7-10ng/mL. Our goal will be 3-5ng/mL) in the immediate post-transplant period thereby reducing the chance of acute and long-term efficacy-limiting adverse effects associated with the tacrolimus while maintaining adequate immunosuppression to reduce acute rejection episodes. This would be the most convincing prospective randomized study utilizing basiliximab as a renal sparing agent in liver transplantation.
Objectives Primary objectives
- To evaluate renal recovery/ function following OLT in patients undergoing orthotopic liver transplant at 6 and 12 months post-transplant.
Secondary objectives (comparing the two treatment arms)
- To determine the tolerability and adverse event profile during the first year post-transplant.
- To determine incidence and severity acute rejection episodes
- To determine the incidence of death and/or graft failure within the first year post-transplant
Study design The study is a single center prospective randomized trial wherein the investigators will have two groups. Patients will be screened and eligible patients will be enrolled pre-transplant. Patients will then be randomized at time of transplant to either the control or treatment arm. Post transplant laboratory data (chemistry, tacrolimus level and liver function tests) will be collected on a daily basis. For the duration of the patients' hospital stay (average 2-3 weeks). This will provide the early data set for early post operative results. Patients will subsequently be followed on a weekly outpatient basis upon discharge as per protocol. During these visits, laboratory data (chemistry, tacrolimus level and liver function tests) are also collected and will provide the continued flow of data for our follow up analysis. Any evidence of rejection will prompt treatment with rescue therapy and if necessary disenrollment from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basiliximab | Experimental | Drug: Basiliximab, Drug: Tacrolimus, Drug: Mycophenolic AcidTacrolimus with Basiliximab induction |
| Tacrolimus Group | Active comparator | Drug: Tacrolimus, Drug: Mycophenolic AcidTacrolimus (without basiliximab induction); standard of care group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- >18 years old
- Undergoing first or second OLT
- MELD (model for end-stage liver disease) score >25
- Serum creatinine > 1.5 or ongoing hemodialysis for less than 4 weeks at the time of transplant
Key exclusion criteria (8 listed)
- <18 years old
- Serum creatinine <1.5
- MELD Score < 25
- Ongoing hemodialysis for 4 or more weeks (those patients become eligible for renal transplants at that point per UCLA practice).
- Receiving OKT3 (Muromonab-CD3), ATG (Antithymocyte Globulin), or IVIG (Intravenous Immunoglobulin Therapy) therapy around time of transplant
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 |
|---|---|---|
| BasiliximabAlso: SimulectPeri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4 | Drug | Basiliximab |
| TacrolimusAlso: PrografDay #7 post-transplant or when serum creatinine (SCr) < 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL | Drug | Basiliximab |
| TacrolimusAlso: PrografDay #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL | Drug | Tacrolimus Group |
| Mycophenolic AcidAlso: Myfortic, Mycophenolate sodiumEnteric coated mycophenolic acid 360-720 mg po bid | Drug | Basiliximab, Tacrolimus Group |
Primary outcome
Renal Recovery/ Function
Time frame: 12 months post-transplant
Number of participants who experienced dialysis independence or improvement based upon kidney function labs as a measure of renal recovery/ function following OLT in patients after undergoing orthotopic liver transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17150025Ramirez CB, Marino IR. The role of basiliximab induction therapy in organ transplantation. Expert Opin Biol Ther. 2007 Jan;7(1):137-48. doi: 10.1517/14712598.7.1.137.
- Background: PubMed 9193849Katari SR, Magnone M, Shapiro R, Jordan M, Scantlebury V, Vivas C, Gritsch A, McCauley J, Starzl T, Demetris AJ, Randhawa PS. Clinical features of acute reversible tacrolimus (FK 506) nephrotoxicity in kidney transplant recipients. Clin Transplant. 1997 Jun;11(3):237-42.
- Background: PubMed 3556303Rimola A, Gavaler JS, Schade RR, el-Lankany S, Starzl TE, Van Thiel DH. Effects of renal impairment on liver transplantation. Gastroenterology. 1987 Jul;93(1):148-56. doi: 10.1016/0016-5085(87)90327-1.
- Background: PubMed 9346596Klintmalm GB, Gonwa TA. Nephrotoxicity associated with cyclosporine and FK506. Liver Transpl Surg. 1995 Sep;1(5 Suppl 1):11-9.
- Background: PubMed 9067697Guckelberger O, Bechstein WO, Neuhaus R, Luesebrink R, Lemmens HP, Kratschmer B, Jonas S, Neuhaus PL. Cardiovascular risk factors in long-term follow-up after orthotopic liver transplantation. Clin Transplant. 1997 Feb;11(1):60-5.
- Background: PubMed 11862589Neuhaus P, Clavien PA, Kittur D, Salizzoni M, Rimola A, Abeywickrama K, Ortmann E, Chodoff L, Hall M, Korn A, Nashan B; CHIC 304 International Liver Study Group. Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: results from a double-blind randomized placebo-controlled trial. Liver Transpl. 2002 Feb;8(2):132-42. doi: 10.1053/jlts.2002.30302.
- Background: PubMed 11862588Calmus Y, Scheele JR, Gonzalez-Pinto I, Jaurrieta EJ, Klar E, Pageaux GP, Scudamore CH, Cuervas-Mons V, Metselaar HJ, Prestele H, Girault D. Immunoprophylaxis with basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, in combination with azathioprine-containing triple therapy in liver transplant recipients. Liver Transpl. 2002 Feb;8(2):123-31. doi: 10.1053/jlts.2002.30882.
- Background: PubMed 10188761Onrust SV, Wiseman LR. Basiliximab. Drugs. 1999 Feb;57(2):207-13; discussion 214. doi: 10.2165/00003495-199957020-00006.
- Background: PubMed 8013792Cherqui D, Duvoux C, Charlotte F, Humeres R, Lauzet JY, Metreau JM, Salvat A, Rotman N, Julien M, Fagniez PL, et al. [Value of a powerful initial immunosuppression after liver transplantation. Prospective study of 60 cases]. Gastroenterol Clin Biol. 1994;18(2):115-22. French.
- Background: PubMed 10512062Berard JL, Velez RL, Freeman RB, Tsunoda SM. A review of interleukin-2 receptor antagonists in solid organ transplantation. Pharmacotherapy. 1999 Oct;19(10):1127-37. doi: 10.1592/phco.19.15.1127.30582.
- 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.
Fady M Kaldas, MD principal investigator
UCLA Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Basiliximab, Tacrolimus and Mycophenolic Acid in people with Liver Transplantation, run by University of California, Los Angeles at 1 site in United States.
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 7 inclusion and 8 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 29 Sep 2022. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Renal Recovery/ Function (time frame: 12 months post-transplant). 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 NCT02123108, which also lists 10 linked publications.
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 29 Sep 2022.