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NCT00646282 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Emory University.

Terminated
Registry status
Phase 4
Development phase
12
Enrollment target

NCT00646282 is a Phase 4 study that was terminated before completion, run by Emory University. The registered enrollment target is 12 participants.

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The verdict

NCT00646282, a Phase 4 study, was terminated before completion, sponsored by Emory University.

TERMINATED
Registry status
Phase 4
Development phase
12 participants
Enrollment target

Study 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.

Interventions

  • DRUG doxercalciferol

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2008-04
Est. Completion 2010-01
Phase Phase 4

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT00646282

The ClinicalTrials.gov registry entry for NCT00646282 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which doxercalciferol is the first listed.

NCT00646282 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00646282 about?

NCT00646282 is a clinical study titled "Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients". 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, w...

What is the current status of trial NCT00646282?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2008-04. Estimated completion is 2010-01.

What interventions are being tested in trial NCT00646282?

The interventions under investigation include: doxercalciferol (DRUG).

Who is sponsoring clinical trial NCT00646282?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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