Induction with Alemtuzumab and maintenance with Tacrolimus and Mycophenolate Mofetil. With standard antimicrobial prophylaxis and calcium supplementation.

Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the lower spine made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the lumbar spine at the end of the first post-transplant year based on bone mineral density results.

Parathyroid hormone (PTH) is a hormone synthesized in the body's parathyroid glands that controls bone health. PTH controls calcium and phosphorus levels in the body. It is measured in the serum and reported in picograms per milliliter (pg/mL).

BAP is a marker of bone turn-over, is measured in the serum and reported in micrograms per liter (mcg/L).

BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements of the lower spine made using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.

BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements made of the hip bones using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.

The number of subject who died (or experienced failure of their kidney surgical graft) during the first year following kidney transplant are reported here.

The number of episodes of ACR, as proven by renal biopsy, were recorded.

Glomerular filtration rate describes the amount that fluid is filtered through the kidney and can be estimated by using serum creatinine. eGFR is reported in milliliters per minute per 1.73 m^2 of body-surface area.

A urine total protein test is conducted to detect excess protein in the urine. This test helps determine an individual's kidney functioning. Protein is not usually present in urine; therefore, presence of protein in the urine is a sign of abnormality. The quantity of protein in a sample of urine collected over 24-hour was measured and reported in milligrams per day.

Interstitial fibrosis refers to degree of scarring or fibrous tissue formed in the kidney. Renal pathologists reviewed biopsies of the subject's kidney grafts for fibrosis, with results expressed using the Banff schema; Quantitative criteria: ci0 = fibrosis observed in up to 5% of cortical area, ci1 = fibrosis in 6%-25% of cortical area (mild) , ci2 = fibrosis in 26%-50% of cortical area (moderate), ci3 = fibrosis in greater than 50% of cortical area (severe). The degree of interstital fibrosis for this study was defined and reported as follows: a Banff ci score of greater than 0 and less than 2 considered "mild" fibrosis and a ci score greater than or equal to 2 as "moderate to severe" fibrosis.

Total of all reporting groups

Not all subjects were diabetic, so the total number of subjects within each arm will not match the number of subjects with diabetes within each arm.

Because this was not the first transplant for some subjects, the number of subjects having their first transplant will not match the total number of subjects in each arm.

Because some of the donor kidneys were from cadaver donors, the number of subjects receiving a kidney from living donors will not match the total number of subjects in each arm.

Interstitial fibrosis refers to degree of scarring or fibrous tissue formed in the kidney. Renal pathologists reviewed biopsies of the subject's kidney grafts for fibrosis, with results expressed according to the Banff schema. The degree of fibrosis was reported using Banff scores (ci) as "mild" (ci greater than 0 and less than 2) or "moderate to severe" (ci greater than or equal to 2). Because not all subjects had interstitial fibrosis in their kidneys, the number with fibrosis will differ from the overall number of subjects in each treatment group.

Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).

Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the hip made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the hip at the end of the first post-transplant year based on bone mineral density results.

Per-protocol analysis. Data were not available for 2 control subjects and 2 treatment subjects, as these subjects did not have the DEXA scan of the hip done at one year. [Control n=42/ Treatment=41]

Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the lower spine made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the lumbar spine at the end of the first post-transplant year based on bone mineral density results.

Per-protocol analysis; Data were not available for 1 subject from each arm because these subjects did not have the one year DEXA scan of the spine. [Control n = 43/Treatment n = 42].

Parathyroid hormone (PTH) is a hormone synthesized in the body's parathyroid glands that controls bone health. PTH controls calcium and phosphorus levels in the body. It is measured in the serum and reported in picograms per milliliter (pg/mL).

Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified timepoints. The number of subjects samples per treatment group were as follows [Timepoint: Control(n)/Treatment(n)]:

Baseline: 43/41, Day 21: 44/41, Day 90: 44/43, Day 365: 44/43

BAP is a marker of bone turn-over, is measured in the serum and reported in micrograms per liter (mcg/L).

Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified study visits. The number of subjects samples per treatment group were as follows [Timepoint: Control(n)/Treatment(n)]:

Baseline: 43/41, Day 21: 34/38, Day 90: 36/36, Day 365: 43/41

BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements of the lower spine made using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.

Per-protocol analysis; Not all subjects were able to undergo the DEXA scan of the spine at baseline and one-year [Control n = 42/Treatment n = 41].

BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements made of the hip bones using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.

Per-protocol analysis. Not all subjects were able to undergo the DEXA scan of the hip at baseline and one-year [Control n = 41/Treatment n = 40].

The number of subject who died (or experienced failure of their kidney surgical graft) during the first year following kidney transplant are reported here.

Per-protocol analysis.

The number of episodes of ACR, as proven by renal biopsy, were recorded.

Per-protocol analysis.

Glomerular filtration rate describes the amount that fluid is filtered through the kidney and can be estimated by using serum creatinine. eGFR is reported in milliliters per minute per 1.73 m^2 of body-surface area.

Per-protocol analysis

Per-protocol analysis

A urine total protein test is conducted to detect excess protein in the urine. This test helps determine an individual's kidney functioning. Protein is not usually present in urine; therefore, presence of protein in the urine is a sign of abnormality. The quantity of protein in a sample of urine collected over 24-hour was measured and reported in milligrams per day.

Per-protocol analysis. The 24-hour urine collection was not completed for all subjects.

Interstitial fibrosis refers to degree of scarring or fibrous tissue formed in the kidney. Renal pathologists reviewed biopsies of the subject's kidney grafts for fibrosis, with results expressed using the Banff schema; Quantitative criteria: ci0 = fibrosis observed in up to 5% of cortical area, ci1 = fibrosis in 6%-25% of cortical area (mild) , ci2 = fibrosis in 26%-50% of cortical area (moderate), ci3 = fibrosis in greater than 50% of cortical area (severe). The degree of interstital fibrosis for this study was defined and reported as follows: a Banff ci score of greater than 0 and less than 2 considered "mild" fibrosis and a ci score greater than or equal to 2 as "moderate to severe" fibrosis.

Per-protocol analysis; graft biopsies were not available for all subjects

Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).

The median PTH level at 90 days was compared between the two treatment groups.

The median PTH level at one year was compared between the two treatment groups.

The median BAP level at 90 days was compared between the two treatment groups.

The median BAP level at one year was compared between the two treatment groups.