Study: NCT01436305

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alemtuzumab
Description: 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.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Alemtuzumab
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MMF
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MMF
Description: 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.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: MMF
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Basiliximab
Description: 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\[s\])

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Short-term Tac
Description: Short-term (3 months)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: tacrolimus
Description: maintenance

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Belatacept
Description: maintenance

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Belatacept
Description: maintenance

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methylprednisolone
Description: All study treatment groups: administration started on the day of transplant and tapered over a 4 day course.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methylprednisolone
Description: All study treatment groups: administration started on the day of transplant and tapered over a 4 day course.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: methylprednisolone
Description: All study treatment groups: administration started on the day of transplant and tapered over a 4 day course.