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

Primary Purpose

Hyperparathyroidism, Hypercalcemia

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
physiological (1.25 mmol/L ) calcium dialysate
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperparathyroidism focused on measuring Dialysate calcium, Mineral metabolism, Parathyroid hormone, Calcification, Cardiovascular disease, Haemodialysis

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • The 1st Affiliated Hospital, Sun Yet-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PCD

NCD

Arm Description

Physiological calcium (1.25 mmol/L) dialysate therapy All subjects in the study phase will continue to take calcium carbonate and/or active vitamin D agents.

Normal calcium (1.5 mmol/L) dialysate therapy All subjects in the study phase will continue to take calcium carbonate and/or active vitamin D agents.

Outcomes

Primary Outcome Measures

Improvement of mineral metabolism and remission of secondary hyperparathyroidism

Secondary Outcome Measures

Improvement of cardiovascular calcification and decrease of clinical cardiovascular events

Full Information

First Posted
August 28, 2008
Last Updated
May 20, 2015
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT00744302
Brief Title
Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.
Official Title
Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Hypercalcemia
Keywords
Dialysate calcium, Mineral metabolism, Parathyroid hormone, Calcification, Cardiovascular disease, Haemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCD
Arm Type
Experimental
Arm Description
Physiological calcium (1.25 mmol/L) dialysate therapy All subjects in the study phase will continue to take calcium carbonate and/or active vitamin D agents.
Arm Title
NCD
Arm Type
Active Comparator
Arm Description
Normal calcium (1.5 mmol/L) dialysate therapy All subjects in the study phase will continue to take calcium carbonate and/or active vitamin D agents.
Intervention Type
Drug
Intervention Name(s)
physiological (1.25 mmol/L ) calcium dialysate
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement of mineral metabolism and remission of secondary hyperparathyroidism
Time Frame
2006-2009
Secondary Outcome Measure Information:
Title
Improvement of cardiovascular calcification and decrease of clinical cardiovascular events
Time Frame
2006-2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueqing Yu, MD
Organizational Affiliation
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tanqi Luo, MD
Organizational Affiliation
Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qiong Luo, MD
Organizational Affiliation
Department of Nephrology, Shen Zhen Affiliated Hospital of Peking University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yaozhong Kong, MD
Organizational Affiliation
Department of Nephrology, the 1st People's Hospital Fo Shan City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Shi, MD
Organizational Affiliation
Department of nephrology, People's Hospital of Guangdong Province
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haitang Hu, MD
Organizational Affiliation
Department of Nephrology, People's Hospital Shun De City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zaiseng Zhou, MD
Organizational Affiliation
Department of Nephrology, People's Hospital of Zhongshan City
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 1st Affiliated Hospital, Sun Yet-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

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

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