Chronic Kidney Disease, Kidney Transplantation
Conditions
Keywords
kidney transplantation, kidney transplant recipients
Brief summary
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.
Detailed description
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.
Interventions
DRUGDoxercalciferol
Active group receives doxercalciferol (Hectorol) 1mcg
DRUGplacebo
Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol)
DRUG25-OH Vitamin D3
All groups received cholecalciferol
Sponsors
Genzyme, a Sanofi Company
Mariana Markell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| - iPTH value of 100 pg/ml or lower | 6 months | The number of patients achieving the target iPTH value of 100 pg/ml or lower measured. Change in the level of iPTH (baseline as compared with 3 and 6 months) using both absolute value and percent change from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 1,25 D2 and D3, 25-OH Vitamin D3 levels | 6 months | The Change in the levels of 1,25 D2 and D3, 25-OH Vitamin D3 levels (baseline as compared with 3 month and end of study) |
| Change in FGF-23 levels | 6 months | The Change in FGF-23 levels (baseline as compared with 3 and 6 months) were measured. |
| Change in serum bone turnover markers | 6 months | The Change in the levels of serum osteocalcin, bone alkaline phosphatase and n-telopeptide of Type I collagen levels (baseline versus 3 and 6 months |
| Change in Protein/creatinine ratio | 6 months | Change in the level of Protein/creatinine ratio and or 24 hour urine for protein (baseline as compared with 3 and 6 months) 6\. Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months) The Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months) |
Countries
United States
Outcome results
None listed