Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients (PAD)
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|ClinicalTrials.gov Identifier: NCT00646282|
Recruitment Status : Terminated (slow enrollment and discontinued once original principal investigator left Emory)
First Posted : March 28, 2008
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Patients with kidney failure on dialysis can be successfully transplanted. However, many of them do not attain a normal kidney function and/or present a slow deterioration of kidney function after transplantation. As a consequence, they can develop an endocrine disorder called hyperparathyroidism, which can cause bone disease and a high risk of bone fractures. In spite of the known bone disease and hyperparathyroidism, there is no well defined treatment for these patients.
Moreover, kidney transplant recipients present a higher mortality rate compared to the general population, and the principal cause of death is cardiovascular disease. Dialysis patients are known to have extensive cardiovascular calcifications and increased vascular stiffness, and these factors have been closely associated with cardiovascular mortality.
The effect of vitamin D on bone health is well known in the general population. Many studies showed a reduction in fracture rate in post-menopausal women and older men receiving vitamin D and calcium supplements. Vitamin D analogues are also commonly used to treat hyperparathyroidism in dialysis patients. Finally, vitamin D has been suggested to have beneficial effects on the cardiovascular system and to reduce mortality in dialysis patients.
Hectorol® is a vitamin D analog which has been demonstrated to effectively treat hyperparathyroidism in dialysis and pre-dialysis patients.
The effects of vitamin D supplementation on bone disease, hyperparathyroidism and cardiovascular function in kidney transplant recipients have not been properly studied.
Whether Hectorol® therapy helps reducing the severity of bone disease and improving vascular function in kidney transplant recipients is still unknown.
|Condition or disease||Intervention/treatment||Phase|
|Hyperparathyroidism, Secondary||Drug: doxercalciferol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney|
|Study Start Date :||April 2008|
|Primary Completion Date :||January 2010|
|Study Completion Date :||January 2010|
Stable kidney transplant recipients will receive Doxercalciferol
The study drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
Other Name: Hectorol
No Intervention: Control
Stable kidney transplant recipients will not receive any drug
- Number of Subjects With 50% Reduction of Intact Parathyroid Hormone (iPTH) Levels [ Time Frame: 18 months ]Number of participants that have 50% reduction in iPTH levels (but not lower than 65 pg/ml) at 18 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646282
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Paolo Raggi and Antonio Guasch, MDs||Emory University|