Status:
COMPLETED
Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
Lead Sponsor:
Mariana Markell
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Chronic Kidney Disease
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ma...
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 ma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00889629
Start Date
November 1 2008
End Date
January 1 2010
Last Update
February 22 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11234