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

NCT00744302 | Completed Phase 2 DMC

• 1 other identifier: SYSU-PRGHD-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperparathyroidism; Hypercalcemia

Keywords

Dialysate calcium; Mineral metabolism; Parathyroid hormone; Calcification; Cardiovascular disease; Haemodialysis

Outcome Measures

Primary Outcomes (1)

• Improvement of mineral metabolism and remission of secondary hyperparathyroidism

  2006-2009

Secondary Outcomes (1)

• Improvement of cardiovascular calcification and decrease of clinical cardiovascular events

  2006-2009

Study Arms (2)

PCD

EXPERIMENTAL

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

NCD

ACTIVE COMPARATOR

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

Interventions

physiological (1.25 mmol/L ) calcium dialysate DRUG

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

NCD; PCD

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Hyperparathyroidism; Hypercalcemia; Calcinosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: April 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

CN (1)