Study: NCT03504241

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Donor-derived Mesenchymal Stromal Cells
Description: These MSCs are a cellular product derived from bone marrow and propagated ex vivo using FDA-approved, clinically applicable methods. Their use in kidney transplantation has been associated with a good safety profile.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: alemtuzumab
Description: Alemtuzumab, 30 mg, given once intravenously (IV) over three hours. The infusion of alemtuzumab shall begin within 24 hours of transplantation surgery and shall be given prior to the first dose of belatacept.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: alemtuzumab
Description: Alemtuzumab, 30 mg, given once intravenously (IV) over three hours. The infusion of alemtuzumab shall begin within 24 hours of transplantation surgery and shall be given prior to the first dose of belatacept.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: belatacept
Description: Belatacept will be given as an intravenous (IV) infusion of 10mg /kg over 1 hour on transplantation postoperative Day 0, Days 5 and 14, then every 2 weeks (± 2 days) for 5 additional doses.Thereafter, belatacept will be given once every 4 weeks (± 5 days) at 10 mg/kg through 24 weeks post-transplant, then at 5 mg/kg every 4-weeks until the participant is evaluated for belatacept discontinuation.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: belatacept
Description: Belatacept will be given as an intravenous (IV) infusion of 10mg /kg over 1 hour on transplantation postoperative Day 0, Days 5 and 14, then every 2 weeks (± 2 days) for 5 additional doses.Thereafter, belatacept will be given once every 4 weeks (± 5 days) at 10 mg/kg through 24 weeks post-transplant, then at 5 mg/kg every 4-weeks until the participant is evaluated for belatacept discontinuation.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: sirolimus
Description: Rapamune® (sirolimus) (Wyeth Pharmaceuticals Inc., Philadelphia, PA) will be started on transplantation postoperative day 1 at a dose of 2 mg/day orally and adjusted to maintain goal 24-hour trough levels of 8-10 ng/ml. Participants who experience grade 3 sirolimus toxicity will undergo dose reduction.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: sirolimus
Description: Rapamune® (sirolimus) (Wyeth Pharmaceuticals Inc., Philadelphia, PA) will be started on transplantation postoperative day 1 at a dose of 2 mg/day orally and adjusted to maintain goal 24-hour trough levels of 8-10 ng/ml. Participants who experience grade 3 sirolimus toxicity will undergo dose reduction.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mycophenolate mofetil
Description: Per protocol, and, only permitted in cases of sirolimus intolerance.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mycophenolate mofetil
Description: Per protocol, and, only permitted in cases of sirolimus intolerance.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mycophenolate acid
Description: Per protocol, and, only permitted in cases of sirolimus intolerance.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mycophenolate acid
Description: Per protocol, and, only permitted in cases of sirolimus intolerance.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: prednisone
Description: Per protocol, and, only permitted in cases of sirolimus intolerance.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: prednisone
Description: Per protocol, and, only permitted in cases of sirolimus intolerance.