Hyperphosphatemia Clinical Trial
Official title:
Arterial Stiffness and Arterial Calcifications Evolution in ESRD Haemodialysis Patients Treated by Sevelamer or Calcium Acetate
Verified date | December 2017 |
Source | Romanian Society of Nephrology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
End-stage renal disease (ESRD) is a state of increased arterial stiffness of extensive vessel
calcifications, compared with the non-renal population. Both arterial stiffness and arterial
calcifications are potent predictors of all-cause and cardiovascular mortality in ESRD
patients. Several studies have documented the direct relationship between the extent and
severity of arterial/coronary calcifications and outcome in dialysis patients. The
relationship is strong no matter if arterial calcifications were quantified by electron-beam
computed tomography or a radiological calcification score. Calcifications are early and
progressive events in these patients. PWV is strongly related to the degree of sonographic
determined arterial calcifications and EBCT-derived coronary artery calcium score in chronic
kidney disease patients.
Calcium-based phosphate binders are associated with progressive coronary artery and aortic
calcification, especially when mineral metabolism is not well controlled.
According to recent studies, sevelamer hydrochloride is a potent non-calcium-containing
phosphate binder, well tolerated in ESRD. Compared with calcium-based phosphate binders,
sevelamer is less likely to cause hypercalcemia, low levels of PTH, and progressive coronary
and aortic calcification in hemodialysis patients. Moreover, sevelamer has a favorable effect
on the lipid profile.
Less is known about the relationship between sevelamer treatment and progression of arterial
stiffness. To date, there is one single study examining the influence of sevelamer (versus
calcium carbonate) on the evolution of arterial stiffness in a very small number (N=15) of
haemodialysis patients. These study used the same patients as historical controls, thus being
methodologically rather weak. Moreover, the follow-up was quite short - 6 month.
The aim of the trial is to to quantify, in a randomized opened-labeled controlled trial the
effect of sevelamer hydrochloride on the evolution of arterial stiffness parameters (pulse
wave velocity and the augmentation index) in chronic haemodialysis patients and to correlate
these parameters with arterial calcification assessed by a previous described radiological
score of arterial calcification and echocardiographic parameters (left ventricular
hypertrophy, LV dilatation, systolic and diastolic dysfunction).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2017 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - more than 3 months on haemodialysis - willingness to participate - age 18-60 yrs - pre-dialysis blood pressure 120-160 mmHg in the last month prior to the initiation of study or recent (<1 Mo) addition of a new antihypertensive drug - iPTH at entry 200-800 pg/mL (as per severe hyperparathyroidism) - serum calcium at entry 2.2-2.6 mmol/L Exclusion Criteria: - haemodynamic instability - uncontrolled hypertension - any severe, debilitating disease associated with a reduced survival - any major cardiovascular event in the last 12 month before study - cinacalcet therapy before study entrance - history of parathyroidectomy - documented history of poor compliance - serious gastrointestinal disease |
Country | Name | City | State |
---|---|---|---|
Romania | "Dr Carol Davila" Teaching Hospital of Nephrology | Bucharest | |
Romania | "CI Parhon" Clinical Hospital | Iasi |
Lead Sponsor | Collaborator |
---|---|
Romanian Society of Nephrology |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in arterial stiffness parameters | 6 months | ||
Primary | changes in calcification score | 6 months | ||
Secondary | composite of all-cause mortality, cardiovascular mortality and major cardiovascular events | 1 year |
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