NCT00889629.

Trial name or title	Pilot study evaluating doxercalciferol replacement therapy in kidney transplant recipients
Methods	Country: USA Study design: parallel RCT Duration of follow‐up: 6 months
Participants	Inclusion criteria: adults of both genders between the ages of 18 and 65; kidney transplant at least 1 year prior to enrolment; 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; hypovitaminosis D, as defined by a 25‐OH Vitamin D value of < 25 ng/mL; iPTH value between 150 and 600 pg/mL Exclusion criteria: history of parathyroidectomy; history of prior intolerance to vitamin D therapy (not including hypercalcaemia); history of biopsy proven acute rejection over the 3 months preceding enrolment; recent (over the past month) addition of an ACEi or ARB (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 enrolment are acceptable); postmenopausal woman or women receiving hormone replacement therapy
Interventions	Treatment group Doxercalciferol: 1 µg 4 times/d then up titrated as per protocol Control group Placebo Co‐interventions Not reported
Outcomes	Number of patients achieving the target iPTH value of 100 pg/mL or lower Change in 1,25 D2 and D3, 25‐OH Vitamin D3 levels iPTH at baseline, 1, 3 and 6 months Change in FGF‐23 levels at baseline, 1, 3 and 6 months Change in serum bone turnover markers Change in protein/creatinine ratio and/or 24 hour urine for protein at baseline, 1, 3 and 6 months
Starting date	November 2008
Contact information	Mariana Markell ‐ State University of New York ‐ Downstate Medical Center
Notes	Recruitment status of the study is unknown because the information has not been verified recently. We could not find any contact details for the contact person on the clinicaltrials.gov website