Study: NCT00023244

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Basiliximab
Description: Administered as a bolus intravenous injection. The first dose is given pre-operatively, the second dose is given on post-transplant day four. Dosage is determined by individual weight.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Basiliximab
Description: Administered as a bolus intravenous injection. The first dose is given pre-operatively, the second dose is given on post-transplant day four. Dosage is determined by individual weight.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclosporine
Description: Participants receiving cyclosporine microemulsion formula (in lieu of tacrolimus) will have the dose adjusted to maintain a whole blood trough Abbott TDx assay monoclonal level of 175-400 ng/mL (or an equivalent high pressure liquid chromatography (HPLC) level) for the first 2 weeks after transplant. The dose will subsequently be tapered to maintain a trough level of 175-300 ng/mL from week 3 to month 3, and 50-250 ng/mL from month 3 through the end of the study at month 36 (year 3).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclosporine
Description: Participants receiving cyclosporine microemulsion formula (in lieu of tacrolimus) will have the dose adjusted to maintain a whole blood trough Abbott TDx assay monoclonal level of 175-400 ng/mL (or an equivalent high pressure liquid chromatography (HPLC) level) for the first 2 weeks after transplant. The dose will subsequently be tapered to maintain a trough level of 175-300 ng/mL from week 3 to month 3, and 50-250 ng/mL from month 3 through the end of the study at month 36 (year 3).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: Participants receiving tacrolimus (in lieu of Cyclosporine) will have the dose adjusted to maintain a whole blood trough level between 10 and 15 ng/mL for the first 4weeks after transplant. Trough levels will be maintained between 5 and 10 ng/mL thereafter throughout the duration of the study.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus
Description: Participants receiving tacrolimus (in lieu of Cyclosporine) will have the dose adjusted to maintain a whole blood trough level between 10 and 15 ng/mL for the first 4weeks after transplant. Trough levels will be maintained between 5 and 10 ng/mL thereafter throughout the duration of the study.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sirolimus
Description: Participants take daily (orally, either as tablets or as liquid) starting on postoperative day 1 at a dose of 6 mg/m2 and will be adjusted to maintain a trough level of 10-20 ng/mL throughout the study.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sirolimus
Description: Participants take daily (orally, either as tablets or as liquid) starting on postoperative day 1 at a dose of 6 mg/m2 and will be adjusted to maintain a trough level of 10-20 ng/mL throughout the study.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylprednisolone
Description: Administered at 10 mg/kg intravenously perioperatively and on postoperative day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylprednisolone
Description: Administered at 10 mg/kg intravenously perioperatively and on postoperative day 1.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prednisone
Description: Administered orally beginning on Post-Op Day 2 and maintained for all participants until day 180. Randomization will determine whether patients will maintain this treatment following day 180.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Administered orally beginning on Post-Op Day 2 and maintained for all participants until day 180. Randomization will determine whether patients will maintain this treatment following day 180.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Bactrim
Description: All subjects will receive TMP SMX (Bactrim), pneumocystis jiroveci (carinii) prophylaxis, beginning on postoperative day 1 and continuing for 6 months following transplant. Dosage: 10 mg/kg taken orally three times weekly (maximum dose 160 mg).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bactrim
Description: All subjects will receive TMP SMX (Bactrim), pneumocystis jiroveci (carinii) prophylaxis, beginning on postoperative day 1 and continuing for 6 months following transplant. Dosage: 10 mg/kg taken orally three times weekly (maximum dose 160 mg).