Status:
TERMINATED
Trial of Calcineurin Inhibitor-Sparing Immunosuppression Regimen in Pediatric Liver Transplantation
Lead Sponsor:
Baylor College of Medicine
Conditions:
End-stage Liver Disease
Renal Insufficiency
Eligibility:
All Genders
Up to 16 years
Phase:
PHASE4
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 tacr...
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 tacr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00656266
Start Date
November 1 2004
End Date
November 1 2005
Last Update
March 13 2020
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030