The Effects and Safety of Low Calcium Dialysis on Coronary Artery Calcification in Maintenance Hemodialysis Patients
The First Affiliated Hospital of Chongqing Medical University
1 other identifier
interventional
200
1 country
1
Brief Summary
This study aim to observe the preventive effect and the long term safety of low calcium dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 13, 2015
CompletedFirst Posted
Study publicly available on registry
July 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJuly 15, 2015
July 1, 2015
1.4 years
July 13, 2015
July 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in coronary artery calcification after 1 year's treatment
1 year
Secondary Outcomes (1)
The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study
1 year
Study Arms (2)
low calcium dialysis
ACTIVE COMPARATORpatients in this group will be dialyzed using a dialysate with a calcium concentration 1.25mmol/L.
Routine dialysis
OTHERPatients in this groups will be dialyzed using routine dialysate with a calcium concentration 1.5mmol/L.
Interventions
patients in this group will receive low calcium dialysis for 1 year.
Eligibility Criteria
You may qualify if:
- Maintenance hemodialysis (MHD) patients who dialyze thrice weekly in our hospital with serum iPTH \<500pg/ml, adjusted serum calcium≧8.4mg/dl in two serial tests.
- Patients who have no chronic infection or malignant tumour and with relatively stable heart and lung function.
- Patients who signed informed consent documents at the time of enrollment in the study.
You may not qualify if:
- Patients whose heart or lung function are poor, or with unstable hemodynamics.
- Patients who are diagnosed active pulmonary tuberculosis, AIDS, malignant tumour, or decompensated liver cirrhosis.
- Patients who are unable or unwilling to cooperate with the researchers in the treatment and follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Study Officials
- STUDY DIRECTOR
Hua Gan, Dr.
First Affiliated Hospital of Chongqing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Nephrology
Study Record Dates
First Submitted
July 13, 2015
First Posted
July 15, 2015
Study Start
September 1, 2014
Primary Completion
February 1, 2016
Study Completion
March 1, 2016
Last Updated
July 15, 2015
Record last verified: 2015-07