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Trial of Calcineurin Inhibitor-Sparing Immunosuppression Regimen in Pediatric 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. Identifier: NCT00656266
Recruitment Status : Terminated (insufficient funding)
First Posted : April 11, 2008
Last Update Posted : April 25, 2008
Information provided by:
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
Liver Transplant Candidates Renal Insufficiency Renal Failure Drug: MMF (Cellcept) Drug: placebo Phase 4

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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
Estimated Primary Completion Date : April 2008
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1
tacrolimus + steroids
Drug: placebo
Experimental: 2
low-dose tacrolimus + steroids + MMF
Drug: MMF (Cellcept)

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 ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00656266

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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine

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Responsible Party: John A. Goss, M.D., Baylor College of Medicine Identifier: NCT00656266     History of Changes
Other Study ID Numbers: H-15138
First Posted: April 11, 2008    Key Record Dates
Last Update Posted: April 25, 2008
Last Verified: April 2008
Keywords provided by Baylor College of Medicine:
renal insufficiency and/or renal failure after liver transplantation
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents