Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
Chronic Kidney Disease, Kidney Transplantation
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring kidney transplantation, kidney transplant recipients
Eligibility 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
Sites / Locations
- SUNY Downstate Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Doxercalciferol
Cholecalciferol
Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Active group receives doxercalciferol (Hectorol) 1mcgwith active titration based on intact PTH plus 25-OH Vitamin D3 (cholecalciferol) 400 IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol if target PTH value is not achieved by the predetermined midpoint.
Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol) plus 25-OH Vitamin D3 (cholecalciferol) 400IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol placebo if target PTH value is not achieved by the predetermined midpoint.