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

NCT00656266 | Terminated Phase 4

• 1 other identifier: H-15138
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Liver Disease; Renal Insufficiency; Renal Failure

Keywords

renal insufficiency or failure; liver transplantation

Outcome Measures

Primary Outcomes (1)

• change in glomerular filtration rate (GFR) two years after liver transplantation as calculated by the Schwartz formula

  change in glomerular filtration rate (GFR) two years after liver transplantation as calculated by the Schwartz formula

  two years

Study Arms (2)

tacrolimus & corticosteroids

PLACEBO COMPARATOR

Standard post-transplant immunosuppression medications: tacrolimus and corticosteroids

Other: placebo medication

low-dose tacrolimus + steroids + MMF

EXPERIMENTAL

Comparison arm: low-dose tacrolimus + steroids + MMF

Drug: mycophenolate mofetil

Interventions

mycophenolate mofetil DRUG

immunosuppresion medication called mycophenolate mofetil, also known as MMF or CellCept

Also known as: CellCept, MMF

low-dose tacrolimus + steroids + MMF

placebo medication OTHER

medication that looks like mycophenolate mofetil

Also known as: placebo pill

tacrolimus & corticosteroids

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

End Stage Liver Disease; Renal Insufficiency

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• John Goss, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: November 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

US (1)