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Trial of Calcineurin Inhibitor-Sparing Immunosuppression Regimen in Pediatric Liver Transplantation

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ClinicalTrials.gov Identifier: NCT00656266
Recruitment Status : Terminated (insufficient funding)
First Posted : April 11, 2008
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
John Goss, Baylor College of Medicine

Brief Summary:
The objective of this study is to compare the effects of two liver transplant immunosuppression regimens on renal function. Patients receiving the standard combination of prednisone and high-dose tacrolimus, a drug with known nephrotoxicity (Arm A) will be compared to patients receiving prednisone, low-dose tacrolimus and mycophenolate mofetil (MMF) (Arm B). MMF is an immunosuppression agent that has no associated nephrotoxicity. The primary end point of the study will be renal function as measured by glomerular filtration rate (GFR). Thirty pediatric liver transplant recipients will be randomized to these two arms in a 1:1 ratio (i.e. 15 patients in each group). Secondary end points will measure patient and graft outcome and incidence of immunosuppression-related complications, including: neurotoxicity, diabetes mellitus, growth retardation, vomiting, diarrhea, gastrointestinal hemorrhage, thrombocytopenia, anemia, leukopenia, acute or chronic liver graft rejection, posttransplant lymphoproliferative disease (PTLD), viral infections, fungal infections and bacterial infections.

Condition or disease Intervention/treatment Phase
End-stage Liver Disease Renal Insufficiency Renal Failure Drug: mycophenolate mofetil Other: placebo medication Phase 4

Detailed Description:
The objective of this study is to compare the effects of two liver transplant immunosuppression regimens on renal function. Patients receiving the standard combination of prednisone and high-dose tacrolimus, a drug with known nephrotoxicity (Arm A) will be compared to patients receiving prednisone, low-dose tacrolimus and mycophenolate mofetil (MMF) (Arm B). MMF is an immunosuppression agent that has no associated nephrotoxicity. The primary end point of the study will be renal function as measured by glomerular filtration rate (GFR). Thirty pediatric liver transplant recipients will be randomized to these two arms in a 1:1 ratio (i.e. 15 patients in each group). Secondary end points will measure patient and graft outcome and incidence of immunosuppression-related complications, including: neurotoxicity, diabetes mellitus, growth retardation, vomiting, diarrhea, gastrointestinal hemorrhage, thrombocytopenia, anemia, leukopenia, acute or chronic liver graft rejection, posttransplant lymphoproliferative disease (PTLD), viral infections, fungal infections and bacterial infections.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Prednisone and Tacrolimus Versus Prednisone, Tacrolimus and Mycophenolate Mofetil in Pediatric Liver Transplantation
Study Start Date : November 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005


Arm Intervention/treatment
Placebo Comparator: tacrolimus & corticosteroids
Standard post-transplant immunosuppression medications: tacrolimus and corticosteroids
Other: placebo medication
medication that looks like mycophenolate mofetil
Other Name: placebo pill

Experimental: low-dose tacrolimus + steroids + MMF
Comparison arm: low-dose tacrolimus + steroids + MMF
Drug: mycophenolate mofetil
immunosuppresion medication called mycophenolate mofetil, also known as MMF or CellCept
Other Names:
  • CellCept
  • MMF




Primary Outcome Measures :
  1. change in glomerular filtration rate (GFR) two years after liver transplantation as calculated by the Schwartz formula [ Time Frame: two years ]
    change in glomerular filtration rate (GFR) two years after liver transplantation as calculated by the Schwartz formula



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • End-stage liver disease or acute fulminant hepatic failure recalcitrant to conventional medical or surgical therapy.
  • Listed as candidate for pediatric liver transplantation listed with United Network for Organ Sharing (UNOS).
  • Patients must be 18 years of age or younger.

Exclusion Criteria:

  • History of autoimmune disease or primary sclerosing cholangitis.
  • History of end-stage renal disease, dialysis treatment or acute renal failure (not including hepatorenal syndrome).
  • Patients with pretransplant renal insufficiency as determined by a glomerular filtration rate (GFR) of <80 mL/min/1.73m2 (see below).
  • Patients with renal agenesis or hypoplasia, polycystic kidney disease, or hydroureter seen on pretransplant renal ultrasound.
  • Patients with malignancy or previous malignancy.
  • Patients with active bacterial, viral, or fungal infections.
  • Patients with a pretransplant diagnosis of diabetes mellitus.
  • Patients with history of previous transplant or multi-organ recipients.
  • Patients with serological evidence of HIV, HBSAg or HCV.
  • Patients with hereditary syndrome that causes genetic deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan or Kelley-Seegmiller syndrome.
  • Patients with history of phenylketonuria.
  • Females that are pregnant or breastfeeding.
  • Sexually active females who are not: a) post-menopausal, or b) surgically sterile, and c) using an acceptable method of contraception (oral contraceptive, implanted devices, injection, and barrier devices are acceptable; condoms used alone are not acceptable).
  • Patients with alcohol abuse, substance abuse or smoking within the previous 6 months.
  • Patients or caretakers of patients with psychogenic factors that preclude therapeutic compliance.
  • Inability to reach participating hospital within 2 hours of notification.
  • Any conditions or any circumstance that makes it unsafe to undergo a liver transplant.

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): NCT00656266


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: John Goss, MD Baylor College of Medicine
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Responsible Party: John Goss, Professor of Surgery, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00656266    
Other Study ID Numbers: H-15138
First Posted: April 11, 2008    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Keywords provided by John Goss, Baylor College of Medicine:
renal insufficiency or failure; liver transplantation
Additional relevant MeSH terms:
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Liver Diseases
End Stage Liver Disease
Renal Insufficiency
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Liver Failure
Hepatic Insufficiency
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action