| Outcome Measures: |
Primary: Number of Subjects With Hyperparathyroidism at One Year, Parathyroid hormone (PTH) is a measure of how well the parathyroid gland is working and is measured by a blood test. Hyperparathyroidism (increased PTH) is defined as PTH blood value greater than 65 picograms/milliliter in the absence of hypocalcemia (low calcium) or if the subject had a parathyroidectomy (surgical removal of parathyroid glands) during the first year post-transplant., 1 year post kidney transplant | Secondary: Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year, 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., 1 year post kidney transplant|Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year, 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., 1 year post kidney transplant|Serum Parathyroid Hormone (PTH) Level Over Time, 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)., Baseline, 3 weeks, 3 months, 1 year post kidney transplant|Serum Bone Alkaline Phosphatase (BAP) Level Over Time, BAP is a marker of bone turn-over, is measured in the serum and reported in micrograms per liter (mcg/L)., Baseline, 21 days, 90 days and 1 year post kidney transplant|Change in Lumbar Spine Bone Mineral Density (BMD), 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., Baseline, 1 year post kidney transplant|Change in Hip Bone Mineral Density (BMD), 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., Baseline, 1 year post kidney transplant|Number of Subjects Who Died or Lost Their Renal Graft During First Year, The number of subject who died (or experienced failure of their kidney surgical graft) during the first year following kidney transplant are reported here., Baseline to 1 year post kidney transplant|Episodes of Acute Cellular Rejection (ACR) of the Renal Transplant, The number of episodes of ACR, as proven by renal biopsy, were recorded., Baseline to 1 year post kidney transplant|Mean Estimated Glomerular Filtration Rate (eGFR) at One Year, 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., 1 year post kidney transplant|Mean Change in Estimated Glomerular Filtration Rate (eGFR) Between 3 Weeks and 1 Year Post Transplant, 3 weeks, 1 year post kidney transplant|24-hour Total Protein in the Urine at 1 Year Post Transplant, 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., 1 year post kidney transplant|Degree of Interstitial Fibrosis on Graft Biopsy at One Year, 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., 1 year post kidney transplant
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| Locations: |
Mayo Clinic, Scottsdale, Arizona, 85259, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States
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