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Sponsor: Mariana Markell
Conditions: Chronic Kidney Disease, Kidney Transplantation
Interventions: Doxercalciferol, placebo, 25-OH Vitamin D3
Countries: United States
People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been discovered that many patients with kidney transplants have low Vitamin D levels. The investigators are examining the effects of doxercalciferol on parathyroid hormone levels, proteinuria and bone turnover markers in people who have had a kidney transplant.
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Adults of both genders between the ages of 18 and 65. * Kidney transplant at least 1 year prior to enrollment * Creatinine value of \<2.5 mg/dl with no excursion \>0.5 within the past 3 months * Proteinuria of 500 mg/24 hours or a protein/creatinine ratio of 0.5 or greater * Hypovitaminosis D, as defined by a 25-OH Vitamin D value of \<25 ng/ml * Intact PTH value between 150 and 600 pg/ml Exclusion Criteria: * History of parathyroidectomy * History of prior intolerance to vitamin D therapy (not including hypercalcemia) * History of biopsy proven acute rejection over the 3 months preceding enrollment * Recent (over the past month) addition of an ACE inhibitor or Angiotensin - * Receptor Blocking agent - patients who have been on a stable dose are acceptable * Current use of active Vitamin D supplement (patients in whom therapy has been discontinued more than 1 month prior to enrollment are acceptable) * Postmenopausal woman or women receiving hormone replacement therapy
- Brooklyn, New York, United States