The Study of Efficacy and Safety of REGPARA Drug in Dialysis Patients Have High Blood Levels of Parathyroid
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
The dialysis patient of chronic kidney disease and parathyroid hormone levels greater than or
equal to 800 Pg per ml were divided into two groups by randomized 1:1, one group to receive
medication and a control group that did not receive the medication. By group to receive in
those taking 25 mg per day to get the default dose and the dose is adjusted according to the
levels of calcium and parathyroid hormone. By adjusting the dose of 25 mg every 3 weeks for a
period of 12 weeks, the drug is between 25-75 mg dose , with a maximum dose of not more than
100 mg per day (weeks 3, 6 , 9).
After a follow-up treatment in weeks 12, 24 and 36 with an blood,ultrasound test parathyroid
glands , abdominal x-ray side . To evaluate the changes without the drug .Unless the track
during treatment the patients with low blood calcium levels over 8.4 mg per dL . No dose
adjustment . regpara while if blood calcium levels less than 7.5 mg per deciliter . Must be
stop taking medication for patients in the control group will receive standard treatment .
Which consisted of dose vitamin D sterol and parathyroid surgery . Unable to control the
level of parathyroid hormone with vitamin D sterol.
While participating in the research are not allowed to adjust the amount of vitamin D sterol
in the two groups . But the amount of dialysate calcium phosphate binders and can be adjusted
as appropriate to healthcare is fine .