Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mariana Markell; State University of New York - Downstate Medical Center
• Collaborator: Genzyme, a Sanofi Company
• Treatments: 1 alpha-hydroxyergocalciferol; Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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