Study: NCT02495077

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Infliximab
Description: A single dose, of 3mg/kg infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylprednisolone
Description: 500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylprednisolone
Description: 500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mycophenolate Mofetil
Description: Administered at a target dose of 2000mg daily, as tolerated, until study closure

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolate Mofetil
Description: Administered at a target dose of 2000mg daily, as tolerated, until study closure

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: Administered at a target dose of 0.1mg/kg BID, post-op, then adjusted to target trough levels of 8-12ng/ml during 1st 3-months post-op and finally adjusted to target trough levels of 5-8ng/ml until study closure

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus
Description: Administered at a target dose of 0.1mg/kg BID, post-op, then adjusted to target trough levels of 8-12ng/ml during 1st 3-months post-op and finally adjusted to target trough levels of 5-8ng/ml until study closure

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Thymoglobulin®
Description: Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Thymoglobulin®
Description: Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Acetaminophen
Description: 30 to 60 minutes prior to the start of the infusion~* Tylenol, 600 to 1000mg by mouth or~* Suppository form

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Acetaminophen
Description: 30 to 60 minutes prior to the start of the infusion~* Tylenol, 600 to 1000mg by mouth or~* Suppository form

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Loratadine
Description: 30 to 60 minutes prior to the start of the infusion~* Claritin (Loratadine) 10mg by mouth or~* Benadryl (Diphenhydramine) 25 or 50 mg by mouth

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Loratadine
Description: 30 to 60 minutes prior to the start of the infusion~* Claritin (Loratadine) 10mg by mouth or~* Benadryl (Diphenhydramine) 25 or 50 mg by mouth

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Placebo for Infliximab
Description: A single dose is volume matched to Infliximab (250mL) infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prednisone
Description: Prednisone will be administered peri-operatively according to center practice. Prednisone should be gradually tapered to no less than 5 mg/day or 10 mg every other day by 3 months post-transplant thereafter until study closure.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Prednisone will be administered peri-operatively according to center practice. Prednisone should be gradually tapered to no less than 5 mg/day or 10 mg every other day by 3 months post-transplant thereafter until study closure.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Diphenhydramine
Description: 30 to 60 minutes prior to the start of the infusion~* Claritin (Loratadine) 10mg by mouth or~* Benadryl (Diphenhydramine) 25 or 50 mg by mouth

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Diphenhydramine
Description: 30 to 60 minutes prior to the start of the infusion~* Claritin (Loratadine) 10mg by mouth or~* Benadryl (Diphenhydramine) 25 or 50 mg by mouth