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Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients

NCT00646282 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-01-26

Study results available
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Summary

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.

Conditions

  • Hyperparathyroidism, Secondary

Interventions

DRUG

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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Paolo Raggi and Antonio Guasch, MDs · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00646282 on ClinicalTrials.gov