NCT01436305

Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation

Optimization of NULOJIX® (Belatacept) Usage as a Means of Avoiding CNI and Steroids in Renal Transplantation (CTOT-10)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Dialysis or kidney transplant are the two ways to treat kidney failure. Transplant recipients have to take anti-rejection medications to prevent their immune system (the body's natural defense system against illness) from rejecting their new kidney. Most patients who undergo a kidney transplant must take these anti-rejection medications for the rest of their lives. Taking standard anti-rejection medications for a long time can cause serious side effects, including kidney damage. There would be a benefit to finding new anti-rejection medications that work just as well, but don't damage the kidney.

Conditions

• Kidney Transplantation
• Renal Transplantation

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
BIOLOGICAL	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\[s\])
DRUG	Short-term Tac	Short-term (3 months)
DRUG	tacrolimus	maintenance
BIOLOGICAL	Belatacept	maintenance
DRUG	methylprednisolone	All study treatment groups: administration started on the day of transplant and tapered over a 4 day course.

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2011-09-19
• Last updated: 2017-09-27
• Results posted: 2017-08-30

Locations

3 sites across 1 country: United States