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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Sun Yat-sen University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00744302
First received: August 28, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hyperparathyroidism
Hypercalcemia
Drug: physiological (1.25 mmol/L ) calcium dialysate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Improvement of mineral metabolism and remission of secondary hyperparathyroidism [ Time Frame: 2006-2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement of cardiovascular calcification and decrease of clinical cardiovascular events [ Time Frame: 2006-2009 ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: April 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCD
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.
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
Active Comparator: NCD
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.
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

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.

  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744302

Locations
China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Xueqing Yu, MD Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Tanqi Luo, MD Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University
Principal Investigator: Qiong Luo, MD Department of Nephrology, Shen Zhen Affiliated Hospital of Peking University
Principal Investigator: Yaozhong Kong, MD Department of Nephrology, the 1st People's Hospital Fo Shan City
Principal Investigator: Wei Shi, MD Department of nephrology, People's Hospital of Guangdong Province
Principal Investigator: Haitang Hu, MD Department of Nephrology, People's Hospital Shun De City
Principal Investigator: Zaiseng Zhou, MD Department of Nephrology, People's Hospital of Zhongshan City
  More Information

No publications provided

Responsible Party: Xueqing Yu/Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00744302     History of Changes
Other Study ID Numbers: SYSU-PRGHD-001
Study First Received: August 28, 2008
Last Updated: August 28, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Dialysate calcium
Mineral metabolism
Parathyroid hormone
Calcification
Cardiovascular disease
Haemodialysis

Additional relevant MeSH terms:
Hypercalcemia
Hyperparathyroidism
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Parathyroid Diseases
Endocrine System Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014