Vitamin D and Carboxy PTH Fragments in Coronary Calcification
Withdrawn before enrolling · Phase 4
Conditions studied: Coronary Calcification, Endstage Renal Disease, Parathyroid Hormone
In brief
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.
Key facts
- Study ID
- NCT00502268
- Run by
- Southeast Renal Research Institute
- People needed
- 0
- Starts
- 2008-02-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2020-12-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient age > 18 and < 80 years of age
- Patients receiving outpatient hemodialysis for > 3 or <24 months duration
- Patients must have baseline coronary calcification defined as at one ROI (regions of interest with >130 Hounsfield units) in 1 or more coronary vessels
- Patients must have a stable dose of phosphate binder for 30 days prior to study enrollment
You may not qualify if…
- Patients intact PTH < 100 or > 1000 pg/ml
- Patients on peritoneal dialysis
- Patients with a previous parathyroidectomy
- Patients with dry weight > 300 lbs
- Patients with chronic atrial flutter or fibrillation
- Patients receiving chronic coumadin therapy
- Patients with known allergies to contrast dyes
- Patients receiving current Cinacalcet therapy or during previous 30 days
- Patients unable to take Metoprolol therapy
- Patients with resting heart rate >100 and unresponsive to beta blockade
- Patients with known pregnancy or unwilling to use contraception during the course of the study
- Patients unable to tolerate the confines of CT scanner
- Patients with a renal transplant within the previous 5 years
- Patients with known aluminum toxicity
- Patients undergoing recent PTCA or CABG within the previous 12 months
- Patients with ESRD secondary to Sarcoidosis
- Patients unwilling to use Selevamer as a primary phosphate binder
Where it is running
- Davita East Charlotte Dialysis Unit — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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