Vitamin D and Carboxy PTH Fragments in Coronary Calcification

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. Identifier: NCT00502268
Recruitment Status : Withdrawn (study never initiated)
First Posted : July 17, 2007
Last Update Posted : March 28, 2016
Information provided by:
Southeast Renal Research Institute

Brief Summary:
Arterial calcification within the coronaries and other vessels is greatly accelerated among patients with chronic or end-stage kidney disease. The mechanisms leading to increased calcification are unknown, but include hyperphosphatemia, hyperparathyroidism and altered vitamin D metabolism. Moreover, recent data demonstrates that circulating carboxy fragments of PTH (7-84) are physiologic antagonists of intact PTH (1-84) and may directly contribute to vascular calcification. Current PTH assays no not distinguish between intact and carboxy PTH fragments leading to an overestimation of intact PTH levels. Because second generation PTH assays detect both 1-84 and 7-84 PTH fragments, the use of vitamin D analogues to treat secondary hyperparathyroidism could lead to excessive suppression of 1-84 and a preponderance of carboxy PTH fragments. Moreover, increased administration of vitamin D analogues amy contribute to vascular calcifications. To investigate these questions, we plan to investigate the effect of managing new ESRD patients using conventional and third generation PTH assays on vitamin D administration and the development of coronary calcification. Hypothesis #1: Clinical management of secondary hyperparathyroidism in new hemodialysis patients using the Scantibodies 1-84/7-84 PTH ratio for one year will reduce the amount of Vitamin D administration resulting in reduced coronary calcification compared to patients in which PTH management is accomplished by conventional, second generation PTH assay.

Condition or disease Intervention/treatment Phase
Coronary Calcification Endstage Renal Disease Parathyroid Hormone Drug: Doxercalciferol administration Drug: Doxercalciferol administered by 1-84-7-84 Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Open-Label Trial Investigating the Effect of 1 Alpha Hydroxy Vitamin D2 on the Development of Coronary Calcification in New ESRD Patients Using the 1-84/7-84 PTH Ratio to Determine Dosing
Study Start Date : February 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Group 1
Doxercalciferol administration by DOQI and 2nd Gen PTH assay
Drug: Doxercalciferol administration
Doxercalciferol administration
Active Comparator: Group 2
Doxercalciferol administered by 1-84-7-84 ratio between 1.4-1.6
Drug: Doxercalciferol administered by 1-84-7-84
Doxercalciferol administered by 1-84-7-84

Primary Outcome Measures :
  1. Percent Change in Hounsfield units of coronary calcification between baseline and after one year of therapy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean dose of Vitamin D2 administered over 12 months [ Time Frame: 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient age > 18 and < 80 years of age
  2. Patients receiving outpatient hemodialysis for > 3 or <24 months duration
  3. Patients must have baseline coronary calcification defined as at one ROI (regions of interest with >130 Hounsfield units) in 1 or more coronary vessels
  4. Patients must have a stable dose of phosphate binder for 30 days prior to study enrollment

Exclusion Criteria:

  1. Patients intact PTH < 100 or > 1000 pg/ml
  2. Patients on peritoneal dialysis
  3. Patients with a previous parathyroidectomy
  4. Patients with dry weight > 300 lbs
  5. Patients with chronic atrial flutter or fibrillation
  6. Patients receiving chronic coumadin therapy
  7. Patients with known allergies to contrast dyes
  8. Patients receiving current Cinacalcet therapy or during previous 30 days
  9. Patients unable to take Metoprolol therapy
  10. Patients with resting heart rate >100 and unresponsive to beta blockade
  11. Patients with known pregnancy or unwilling to use contraception during the course of the study
  12. Patients unable to tolerate the confines of CT scanner
  13. Patients with a renal transplant within the previous 5 years
  14. Patients with known aluminum toxicity
  15. Patients undergoing recent PTCA or CABG within the previous 12 months
  16. Patients with ESRD secondary to Sarcoidosis
  17. Patients unwilling to use Selevamer as a primary phosphate binder

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 identifier (NCT number): NCT00502268

United States, North Carolina
Davita East Charlotte Dialysis Unit
Charlotte, North Carolina, United States, 28208
Sponsors and Collaborators
Southeast Renal Research Institute
Principal Investigator: James A. Tumlin, MD Southeast Renal Research Institute

Responsible Party: James A. Tumlin MD, Southeast Renal Research Institute Identifier: NCT00502268     History of Changes
Other Study ID Numbers: SBPTH-CC1
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016

Keywords provided by Southeast Renal Research Institute:
Coronary Calcification
Endstage Renal Disease
Parathyroid hormone

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vitamin D
1 alpha-hydroxyergocalciferol
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents