Clinical Trial: Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.

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 and cardiovascular calcification in prevalent haemodialysis patients. And the long term safety of the 1.25 mmol/L calcium dialysate was also considered.

There are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study.

Phase 2 (intervention phase). Each subject will be randomly allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36 months.

Detailed Summary:

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 calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36 months.

Calcium carbonate was mainly used as the phosphate binder. Active vitamin D metabolite, calcitriol (Rocaltrol, Hoffmann La Roche, and Basel, Switzerland) was given as to control the secondary hyperparathyroidism. The doses of these agents were adjusted according to the serum calcium level, serum phosphate level, calcium-phosphorus product and serum iPTH level, which were recommended by the K/DOQI Guidelines 6.3b and 8B. Aluminum hydroxide might be introduced as a phosphate binder for no more than 4 weeks in addition to calcium carbonate and dietary restriction when serum phosphate level could not get a good control (serum P level≥1.78 mmol/L, lasting above 4 weeks). A non- calcium-containing phosphate binder could be administered for 1~2 weeks in patients with hypercalcaemia during the observation. At the time of the study, non-calcium, non-aluminum based phosphate binders as well as calcium acetate were not available in our country.

Sponsor: Sun Yat-sen University

Current Primary Outcome: Improvement of mineral metabolism and remission of secondary hyperparathyroidism [ Time Frame: 2006-2009 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Improvement of cardiovascular calcification and decrease of clinical cardiovascular events [ Time Frame: 2006-2009 ]

Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: August 28, 2008
Date Started: April 2006
Date Completion:
Last Updated: May 20, 2015
Last Verified: May 2015