A Prospective Randomized Trial of Prednisone and Tacrolimus Versus Prednisone, Tacrolimus and Mycophenolate Mofetil in Pediatric Liver Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- change in glomerular filtration rate (GFR) two years after liver transplantation as calculated by the Schwartz formula
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
tacrolimus & corticosteroids
Standard post-transplant immunosuppression medications: tacrolimus and corticosteroids
干预措施: placebo medication (Other)
low-dose tacrolimus + steroids + MMF
Comparison arm: low-dose tacrolimus + steroids + MMF
干预措施: mycophenolate mofetil (Drug)
结局指标
主要结局
change in glomerular filtration rate (GFR) two years after liver transplantation as calculated by the Schwartz formula
时间窗: two years
change in glomerular filtration rate (GFR) two years after liver transplantation as calculated by the Schwartz formula
次要结局
未报告次要终点
研究者
John Goss
Professor of Surgery
Baylor College of Medicine