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

This study has been terminated.
(slow enrollment and discontinued once original principal investigator left Emory)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00646282
First Posted: March 28, 2008
Last Update Posted: January 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Antonio Guasch, M.D., Emory University
  Purpose

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 Intervention Phase
Hyperparathyroidism, Secondary Drug: doxercalciferol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney

Resource links provided by NLM:


Further study details as provided by Antonio Guasch, M.D., Emory University:

Primary Outcome Measures:
  • 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


Enrollment: 12
Study Start Date: April 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxercalciferol
Stable kidney transplant recipients will receive Doxercalciferol
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.
Other Name: Hectorol
No Intervention: Control
Stable kidney transplant recipients will not receive any drug

Detailed Description:
The investigators plan to study the cardiovascular and bone effects of Hectorol® in 100 kidney transplant recipients. The kidney transplant patients will be screened for kidney transplant dysfunction and hyperparathyroidism. The study medication will be given to 50 patients. The other 50 patients will continue to be treated with the actual standard of care at the transplant clinic. Subjects will be followed for 18 months and their laboratory values, bone density, vascular calcification and stiffness will be collected to see if there is an effect of Hectorol® compared to the actual standard of care.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kidney transplant recipient > 18 year/old with reduced and stable kidney function (estimated GFR 25-60 ml/min/1.73m2)
  • iPTH levels between 120 and 500 pg/ml
  • Stable immunosuppressive therapy (5-10 mg Prednisone/day, stable dosage of calcineurin inhibitors, or other immunosuppressive agents for at least 6 months)

Exclusion Criteria:

  • Recent rejection episode (< 3 months)
  • One of the following: baseline estimated GFR>60 ml/min/1.73m2 or <25 ml/min/1.73m2, albumin-corrected Ca>9.5 mg/dl or serum phosphorus >4.6 mg/dl.
  • Recipients of dual transplant organs with exception of kidney-pancreas
  • Patients already receiving treatment with Vitamin D analogues
  • Severe peripheral vascular disease or coronary artery disease
  • History of previous parathyroidectomy
  • Current alcohol or drug abuse
  • Pregnant or nursing woman or female of child-bearing age not receiving contraception
  • Other comorbidities that in the opinion of the investigators would reduce expected patient's survival and preclude study completion
  • Medications that could interfere with Hectorol® metabolism
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Paolo Raggi and Antonio Guasch, MDs Emory University
  More Information

Responsible Party: Antonio Guasch, M.D., Professor, Emory University
ClinicalTrials.gov Identifier: NCT00646282     History of Changes
Other Study ID Numbers: IRB00006614
First Submitted: March 25, 2008
First Posted: March 28, 2008
Results First Submitted: January 14, 2015
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
Vitamin D
1 alpha-hydroxyergocalciferol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents