Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
Completed · Phase 4 · Has a placebo group
Conditions studied: Chronic Kidney Disease, Kidney Transplantation
In brief
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.
Key facts
- Study ID
- NCT00889629
- Run by
- Mariana Markell
- People needed
- 39
- Starts
- 2008-11-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2019-02-22
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- SUNY Downstate Medical Center — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
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