Status:
COMPLETED
Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hyperparathyroidism
Hypercalcemia
Eligibility:
All Genders
14-65 years
Phase:
PHASE2
Brief Summary
A prospective, randomized, controlled multicenter trial to evaluate 1.25 mmol/L (physiological) vs. 1.5 mmol/L calcium dialysate on serum markers of mineral metabolism, secondary hyperparathyroidism a...
Detailed Description
All patients recruited from these centers who met the inclusion criteria were randomly allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calciu...
Eligibility Criteria
Inclusion
- Willingness to sign an informed consent
- Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
- Secondary hyperparathyroidism defined as serum intact parathyroid hormone (iPTH) \> 150 pg/mL, hypercalcemia defined as serum Ca \> 2.2 mmol/L and /or calcium phosphate product ≥55mg2/dl2
Exclusion
- Inability or unwillingness to sign the informed consent
- Cardiac arrhythmia
- Serious renal osteopathy
- Oral active vitamin D and/or calcium carbonate intolerance
- Poor compliance or unwillingness to meet the scheme demands raised by the investigators
- Patients who had undergone percutaneous ethanol injection therapy or parathyroidectomy for secondary hyperparathyroidism
- Patients who had previously been treated and/or were being treated with glucocorticoid, which affects bone metabolism.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00744302
Start Date
April 1 2006
End Date
December 1 2009
Last Update
May 22 2015
Active Locations (1)
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1
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China, 510080