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Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA Following Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02123108
Recruitment Status : Unknown
Verified April 2014 by Fady M Kaldas, M.D., F.A.C.S., University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : April 25, 2014
Last Update Posted : April 25, 2014
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Fady M Kaldas, M.D., F.A.C.S., University of California, Los Angeles

Brief 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. 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.

This study will enroll 60 subjects. 30 subjects in each of the two groups. Subjects will be followed for 1 year after liver transplant.


Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: Basiliximab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Immunosuppression With Basiliximab, Delayed Dose Tacrolimus Plus Enteric Coated Mycophenolic Acid, Versus Standard Dose Tacrolimus, Enteric Coated Mycophenolic Acid Plus Corticosteroids in Patients Undergoing Orthotopic Liver Transplantation (OLT)
Study Start Date : January 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Basiliximab

Basiliximab

Basiliximab Peri-transplant

• 40mg IV infusion within 4 hours of transplant x1

Basiliximab Post-transplant • 20mg IV infusion Post Operative Day #4 (POD 4) x1

Tacrolimus (with basiliximab induction)

• Post Operative Day #7 (POD 7) or subclinical acute rejection (SCr) < 1.8 mg/dl to one year: 0.03-0.1mg/kg q12h

  • Mycophenolate/mycophenolic acid will be started Post Operatively Day 1: 720 mg po bid will be administered once the patient is able to tolerate PO medication.

Corticosteroids • Intraoperative: hydrocortisone 1000mg intravenous push (IVP)

Followed by:

• Standard steroid taper:

Drug: Basiliximab
Peri-operative 40 mg IV dose and 20mg IV postoperative dose will be given in the treatment arm
Other Name: Simulect

No Intervention: Tacrolimus Group

Tacrolimus (without basiliximab induction); standard of care group

  • Beginning Post Operative Day #1 to six months: 0.03-0.1 mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL
  • Six months to one year: maintain whole blood trough concentration of 5-8ng/mL

    • Mycophenolate/mycophenolic acid will be started Post Operatively Day 1. Immediately post transplant, while subjects have nasogastric (ng) tube; this will be delivered as CellCept (mycophenolate mofetil) oral suspension 1,000 mg BID administered via the ng tube. Enteric coated mycophenolic acid (Myfortic) - 720 mg po bid will be administered once the patient is able to tolerate PO medication.

Corticosteroids • Intraoperative: hydrocortisone IVP

Followed by:

• Standard steroid taper




Primary Outcome Measures :
  1. To evaluate renal recovery/ function following OLT in patients undergoing orthotopic liver transplant at 6 and 12 months post-transplant. [ Time Frame: 12 months post-transplant ]
    We will evaluate renal recovery/ function following OLT in patients undergoing orthotopic liver transplant at 6 and 12 months post-transplant.


Secondary Outcome Measures :
  1. To determine the tolerability during the first year post-transplant and to determine incidence and severity acute rejection episodes [ Time Frame: 12 months post liver transplantation ]
    We will determine the tolerability and adverse event profile during the first year post-transplant.


Other Outcome Measures:
  1. To determine the adverse event profile during the first year post-transplant. [ Time Frame: 12 months post liver transplantation ]
    We will look to determine the adverse event profile during the first year post-transplant.

  2. To determine incidence and severity acute rejection episodes [ Time Frame: 12 months post liver transplant ]
    We will look to determine incidence and severity acute rejection episodes

  3. To determine the incidence of death within the first year post-transplant [ Time Frame: 12 months post liver transplant ]
    We will look to determine the incidence of death within the first year post-transplant

  4. To determine the incidence of graft failure within the first year post-transplant [ Time Frame: 12 months post transplant ]
    We will look to determine the incidence of graft failure within the first year post-transplant



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients eligible for inclusion in this study have to fulfill all of the following criteria:

  • >18 years old
  • Undergoing first or second OLT
  • Meld 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.

Exclusion Criteria:

  • <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, ATG, or IVIG 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123108


Contacts
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Contact: Fady M Kaldas, MD 310-825-5318 fkaldas@mednet.ucla.edu
Contact: Curtis D Holt, PharmD 310-206-4952 cholt@mednet.ucla.edu

Locations
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United States, California
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Fady M Kaldas, MD    310-825-5318    fkaldas@mednet.ucla.edu   
Contact: Curtis D Holt, PharmD    310-206-4952    cholt@mednet.ucla.edu   
Principal Investigator: Fady M Kaldas, MD         
Sponsors and Collaborators
University of California, Los Angeles
Novartis
Investigators
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Principal Investigator: Fady M Kaldas, MD UCLA Department of Surgery
Publications:

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Responsible Party: Fady M Kaldas, M.D., F.A.C.S., Principle-Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02123108    
Other Study ID Numbers: UCLA: CCHI621AUS17T
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014
Keywords provided by Fady M Kaldas, M.D., F.A.C.S., University of California, Los Angeles:
Simulect, Myfortic, OLT, Renal Dysfunction, Liver Transplant, Orthotopic Liver Transplantation
Additional relevant MeSH terms:
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Basiliximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs