Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/24/2019 |
| Start Date: | November 2008 |
| End Date: | January 2010 |
Pilot Study: Effects of Hectorol (Doxercalciferol) Vitamin D Replacement on Proteinuria, PTH Level and Bone Turnover in Stable Kidney Transplant Recipients: a Single-Blind, Placebo-Controlled Study in Patients Receiving 25-OH Vitamin D3
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.
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.
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.
25-OH Vitamin D3 is now recommended to treat kidney transplant patients with low vitamin D
levels but it may not be enough to treat the parathyroid problems and bone disease.
Doxercalciferol is a form of Vitamin D that has been used to treat bone disease and
parathyroid problems in dialysis patients but has not yet been studied in patients with
kidney transplants. We are interested in seeing whether doxercalciferol given together with
25-OH Vitamin D3 will be a better treatment for the overactive parathyroid gland and bone
disease than 25-OH Vitamin D3 alone in patients with kidney transplants.
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.
25-OH Vitamin D3 is now recommended to treat kidney transplant patients with low vitamin D
levels but it may not be enough to treat the parathyroid problems and bone disease.
Doxercalciferol is a form of Vitamin D that has been used to treat bone disease and
parathyroid problems in dialysis patients but has not yet been studied in patients with
kidney transplants. We are interested in seeing whether doxercalciferol given together with
25-OH Vitamin D3 will be a better treatment for the overactive parathyroid gland and bone
disease than 25-OH Vitamin D3 alone in patients with kidney transplants.
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
We found this trial at
1
site
450 Clarkson Avenue
Brooklyn, New York 11203
Brooklyn, New York 11203
(718) 270-1000
Principal Investigator: Mariana Markell, MD
Phone: 718-270-8216
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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