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Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would minimize serious long term side effects associated with anti-rejection medications while still protecting the new kidney from damage. The researchers also wanted to learn more about the safety of this treatment and long term health of the transplanted kidney.
Official title: Optimization of NULOJIX® (Belatacept) Usage as a Means of Avoiding CNI and Steroids in Renal Transplantation (CTOT-10)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
19
Start Date
2011-09
Completion Date
2015-04
Last Updated
2026-09-24
Healthy Volunteers
No
Interventions
Alemtuzumab
Induction therapy. Group 1 and 2 study therapy regimens include induction with alemtuzumab, administered as a single intravenous dose intra-operatively over a period of 2 hours.
MMF
All treatment groups (e.g., Group 1, 2 and 3): Administered at a target dose of 1000 mg by mouth twice daily beginning on the day of surgery or post operative day 1 and adjusted as clinically warranted. Note: Myfortic® (mycophenolate sodium) may be used as a replacement for MMF, at a dose of 720 mg taken by mouth twice daily.
Basiliximab
Induction therapy. Group 3 study therapy regimen includes induction with basiliximab, administered in two doses: 1 dose administered within 2 hours prior to transplantation surgery and the 2nd dose 4 days after transplantation (unless held due to contraindication\[s\])
Short-term Tac
Short-term (3 months)
tacrolimus
maintenance
Belatacept
maintenance
methylprednisolone
All study treatment groups: administration started on the day of transplant and tapered over a 4 day course.
Locations (3)
University of Alabama
Birmingham, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States