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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Emory University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00646282
First received: March 25, 2008
Last updated: March 27, 2008
Last verified: March 2008
  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.

We plan to study the cardiovascular and bone effects of Hectorol® in 100 kidney transplant recipients followed at our Transplant Clinic. We will screen kidney transplant patients 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 our Transplant Clinic. We will follow these patients for 18 months and monitor laboratory values, bone density, vascular calcification and stiffness to detect any effect of Hectorol® compared to the actual standard of care.


Condition Intervention Phase
Hyperparathyroidism, Secondary
Drug: doxercalciferol
Other: standard of care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Emory University:

Primary Outcome Measures:
  • iPTH serum levels [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bone mineral density, vascular calcification, vascular stiffness, endothelial function, estimated glomerular filtration rate, proteinuria, rejection rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
2
Standard of care
Other: standard of care
No study drug
Other Name: No intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646282

Contacts
Contact: Paolo Raggi, MD 404-778-5414 praggi@emory.edu
Contact: Antonio Guasch, MD 404-727-3959 aguasch@emory.edu

Locations
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Paolo Raggi, MD    404-778-5414    praggi@emory.edu   
Contact: Antonio Guasch, MD    404-727-3959    aguasch@emory.edu   
Sub-Investigator: Francesca Cardarelli, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Paolo Raggi and Antonio Guasch, MDs Emory University
  More Information

No publications provided

Responsible Party: Dr Paolo Raggi and Dr Antonio Guasch, Emory University
ClinicalTrials.gov Identifier: NCT00646282     History of Changes
Other Study ID Numbers: IRB00006614
Study First Received: March 25, 2008
Last Updated: March 27, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014