The Study of Efficacy and Safety of REGPARA Drug in Dialysis Patients Have High Blood Levels of Parathyroid

Launched by CHULALONGKORN UNIVERSITY · Feb 4, 2014

Keywords

ClinConnect Summary

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, second...

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Eligibility criteria

• Inclusion Criteria:
• • 1. The patient have age more equal 18 year on enrollment date. 2. The patient get the dialysis of 3 times per week 3. The parathyroid hormone level greater than or equal to 800 pg per mL during the screening 4.The calcium level in the blood is greater than or equal to 9 mg per dL.
• Exclusion Criteria:
• • 1. The patient had parathyroid gland surgery.
• • 2. The patient have a history of seizures within 12 weeks before randomized.
• • 3. The patient is scheduled for surgery the kidney
• • 4. The patient will expected parathyroid gland surgery within 6 months
• • 5. The liver function have abnormalities, including SGOT, SGPT, more than two fold
• • 6. The patient had history received a drug of bisphosphonates group or expected to be received during the study.
• • 7. The patient had a history of cancer. Pregnant women. Lactating women. And with sepsis -