The Effects of Different Dialysate Calcium Concentration

The Effects of Different Dialysate Calcium Concentration on Mineral-bone Metabolism in Chinese Patients on Maintenance Hemodialysis

The investigators enrolled 90 patients on maintenance hemodialysis with dialytic vintage ≥12 months, iPTH 150-300pg/ml and serum calcium<2.5mmol/L. Patients were randomized to three groups with different dialysate calcium concentration , 1.25 mmol/L(DCa1.25), 1.5mmol/L(DCa1.5) and 1.75 mmol/L(DCa1.75) for 24 months respectively. Hemodialysis was performed for 4 hours three times weekly. Serum total calcium(tCa), ionized calcium(iCa),intact parathyroid hormone(iPTH)and phosphorus (P) levels were recorded before and after the study and single dialysis session in every patient. iCa and P levels were measured in spent dialysate.Bone density, bone-specific alkaline phosphatase(BAP), osteoprotegerin(OPG)、β-crosslaps、total Procollagen Type I Intact Propeptide (P1NP）and vascular calcification were measured in every patient periodically. vascular calcification including aortic arch calcification, abdominal aorta calcification and coronary artery calcification were measured by chest radiography, lateral lumbar radiographs and coronary artery computer tomography (CT) respectively. The primary endpoints included death, cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke), newly nontraumatic bone fracture, secondary parathyroidism uncontrolled by medicine and valvular or vascular calcification. The secondary endpoint were admission or emergency observation.

Study Overview

• Status: Unknown
• Conditions: Mineral-bone Metabolism
• Intervention / Treatment: Other: different dialysate calcium concentration

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-65, maintenance hemodialysis, dialytic vintage ≥12 months, iPTH 150-300pg/ml, serum calcium<2.5mmol/L, serum calcium<2.5mmol/L.

Exclusion Criteria:

• Age<18 or >65 Severe acid-base disturbance History of parathyroid glands or adrenal gland combined with consumptions or malnutrition anemia due to acute bleeding or other diseases except for renal failure newly occurred bone fracture within 3 months active stage of immunological diseases using glucocorticoid or immunosuppressor combined with any disease with expect duration <2 year newly occurred acute heart failure, acute myocardial failure , acute cerebral infarction or stroke within 6 months pregnant women of women in preparation for pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: DCa1.25; using dialysate calcium concentration 1.25 mmol/L(DCa1.25)	Other: different dialysate calcium concentration
ACTIVE_COMPARATOR: DCa1.5; using dialysate calcium concentration 1.5mmol/L	Other: different dialysate calcium concentration
ACTIVE_COMPARATOR: DCa1.75; using dialysate calcium concentration 1.75mmol/L	Other: different dialysate calcium concentration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
death	incidence of death	24months
cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke)	incidence of cardio-cerebral vascular disease	24months
newly nontraumatic bone fracture	incidence of newly nontraumatic bone fracture	24months
secondary hyperparathyroidism uncontrolled by medicine	incidence of secondary hyperparathyroidism uncontrolled by medicine	24months
valvular or vascular calcification	incidence of valvular or vascular calcification	24months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
admission or emergency observation	incidence of admission or emergency observation	24months

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: April 22, 2013
• First Posted (ESTIMATE): April 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 30, 2013
• Last Update Submitted That Met QC Criteria: April 29, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Pharmaceutical Solutions; Calcium; Dialysis Solutions
• Other Study ID Numbers: BJFH-EC/2013-020