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

This study has been terminated.
(insufficient funding)
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00656266
First received: April 7, 2008
Last updated: April 22, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Liver Transplant Candidates
Renal Insufficiency
Renal Failure
Drug: MMF (Cellcept)
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Prednisone and Tacrolimus Versus Prednisone, Tacrolimus and Mycophenolate Mofetil in Pediatric Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • change in glomerular filtration rate (GFR) two years after liver transplantation as calculated by the Schwartz formula [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: November 2004
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
tacrolimus + steroids
Drug: placebo
Experimental: 2
low-dose tacrolimus + steroids + MMF
Drug: MMF (Cellcept)

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656266

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

No publications provided

Responsible Party: John A. Goss, M.D., Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00656266     History of Changes
Other Study ID Numbers: H-15138
Study First Received: April 7, 2008
Last Updated: April 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
renal insufficiency and/or renal failure after liver transplantation

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Mycophenolate mofetil
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014