Clinical Research
Clinical Trials in Abdominal Transplantation
Clinical trials within the Divison of Abdominal Transplantation include: Tolerance Induction, EVB-induced post-transplant lymphoma, and the following Stanford-based trials for liver, kidney, intestine, pacreas, diabetes, and hepatocellular carcinoma.
This page provides an auto-populated up-to-date list of Stanford Clinical Trials in: liver, kidney, intestine, pancreas, diabetes, hepatocellular carcinoma, and pediatric transplant.
Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
The purpose of this study is to evaluate how well adolescent kidney transplant patients tolerate a single dose of belatacept they receive at least 6 months after transplant surgery, and how their body handles the drug.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Belatacept
Eligibility
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Male and Female subjects,12-17 years old
- Receiving CNI-based maintenance immunosuppression since the time of renal
transplantation in accordance with local standard of care
- Stable renal function, in the opinion of the investigator, with a cGFR>45
mL/min/1.73m2 at the time of enrollment (per updated Schwartz Formula)
- Adolescent Recipients of a renal allograft from a living donor or a deceased donor at
least 6 months prior to enrollment
- Subject must be receiving a calcineurin inhibitor (CNI)-based [cyclosporine (CsA) [any
formulation] or Tacrolimus (TAC)] immunosuppressive regimen
- Subject must be receiving adjunctive background maintenance immunosuppression with
mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium
(EC-MPS)/mycophenolic acid (MPA)
- Subjects may be receiving maintenance corticosteroids in accordance with the local
standard of care
- Negative Interferon Gamma Release Assay (IGRA) such as QuantiFERON-TB Gold test or
T-Spot-TB
- FOCBP must have negative serum or urine pregnancy test within 24 hrs prior to start of
study medication
- Subject must have stable estimated glomerular filtration rate (GFR) ≥45 mL/min/1.73m2
(updated Schwartz formula)
Exclusion Criteria:
- Epstein-Barr virus (EBV) serostatus negative or unknown at time of transplant and
screening
- History of any treated or biopsy proven acute rejection (BPAR) within 3 months prior
to enrollment
- Subjects who have experienced more than 1 episode of acute rejection (AR) of the
current allograft or any antibody-mediated AR
- Subjects with any active infection [including, but not limited to, positive
cytomegalovirus (CMV) or BK viral (BKV) loads, BKV associated nephropathy (BKVAN), CMV
retinitis, CMV colitis, etc.]
- Urine albumin:creatinine ratio > 56.5 mg/mmol (> 0.5 mg albumin / mg creatinine) on a
random voided urine specimen
Ages Eligible for Study
12 Years - 17 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Paul Grimm, Site 0006
650-725-5295
Not Recruiting