The Study of Efficacy and Safety of REGPARA Drug in Dialysis Patients Have High Blood Levels of Parathyroid
Condition: Hyperparathyroidism, Secondary
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 4

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 .
    

Detailed description: 
      The renal impairment is caused FGF-23 resistance to the congestion of phosphate and stimulate
      the secretion of parathyroid hormone (PTH) from the parathyroid gland causes secondary
      hyperparathyroidism. They also found that high levels of FGF-23 is also a risk factor of
      vascular calcification.

      The Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) is a disorder caused by renal
      impairment cause abnormalities occurring in the body. Can be summarized into three main parts
      as follows : 1) The disorders of minerals and hormones (laboratory abnormalities) such as
      hyperphosphatemia, secondary hyperparathyroidism. 2 ) The disorders of bone (bone
      abnormalities) , formerly known as renal osteodystrophy 3) The vascular calcification which
      results happened increase the risk of heart disease and stroke (cardiovascular disease) ,
      broken bones (fractures) and death rate (mortality).

      The secondary hyperparathyroidism. PTH secretion from parathyroid glands are more than normal
      and a major cause of the congestion of phosphate , reduced levels of 1,25-dihydroxyvitamin D
      [1,25 (OH) 2D] in the blood and a decrease in blood calcium levels decreased calcium levels
      in the blood is low. will result in a calcium (calcium sensing receptor or CaSR) on
      parathyroid glands make parathyroid cell signaling and increased PTH secretion .

      That PTH increased continuously in the long run will cause the destruction of the bone called
      bone decay know "osteitis fibrosa". Some patients with a bone fracture. Important
      characteristics of osteitis fibrosa is an increase of bone destruction(osteoclastic bone
      resorption). In addition, the bone marrow may also be found associated with bone marrow
      fibrosis which causes anemia and did not respond to erythropoietin.
    

Intervention name(s): calcium sensing receptor agonist
Intervention type(s): Drug
Intervention description(s): For the Regpara 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).
Other intervention name(s): Regpara
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hemodialysis patients; Hyperparathyroidism; Regpara; FGF 23