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

NCT00744302 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2015-05-22

No results posted yet for this study

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.

Conditions

  • Hyperparathyroidism
  • Hypercalcemia

Interventions

DRUG

physiological (1.25 mmol/L ) calcium dialysate

Using the physiological calcium dialysate (1.25 mmol/L calcium dialysate)for Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xueqing Yu, MD · Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

  • Tanqi Luo, MD · Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University

  • Qiong Luo, MD · Department of Nephrology, Shen Zhen Affiliated Hospital of Peking University

  • Yaozhong Kong, MD · Department of Nephrology, the 1st People's Hospital Fo Shan City

  • Wei Shi, MD · Department of nephrology, People's Hospital of Guangdong Province

  • Haitang Hu, MD · Department of Nephrology, People's Hospital Shun De City

  • Zaiseng Zhou, MD · Department of Nephrology, People's Hospital of Zhongshan City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00744302 on ClinicalTrials.gov