The Effects of Different Dialysate Calcium Concentration

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Beijing Friendship Hospital
Sponsor:
Information provided by (Responsible Party):
Wenhu Liu, Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT01839383
First received: April 22, 2013
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Mineral-bone Metabolism
Other: different dialysate calcium concentration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Different Dialysate Calcium Concentration on Mineral-bone Metabolism in Chinese Patients on Maintenance Hemodialysis

Resource links provided by NLM:


Further study details as provided by Beijing Friendship Hospital:

Primary Outcome Measures:
  • death [ Time Frame: 24months ] [ Designated as safety issue: No ]
    incidence of death

  • cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke) [ Time Frame: 24months ] [ Designated as safety issue: No ]
    incidence of cardio-cerebral vascular disease

  • newly nontraumatic bone fracture [ Time Frame: 24months ] [ Designated as safety issue: No ]
    incidence of newly nontraumatic bone fracture

  • secondary hyperparathyroidism uncontrolled by medicine [ Time Frame: 24months ] [ Designated as safety issue: No ]
    incidence of secondary hyperparathyroidism uncontrolled by medicine

  • valvular or vascular calcification [ Time Frame: 24months ] [ Designated as safety issue: No ]
    incidence of valvular or vascular calcification


Secondary Outcome Measures:
  • admission or emergency observation [ Time Frame: 24months ] [ Designated as safety issue: No ]
    incidence of admission or emergency observation


Estimated Enrollment: 90
Study Start Date: June 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01839383

Locations
China, Beijing
Beijing Friendship hospital Not yet recruiting
Beijing, Beijing, China, 100050
Contact: Wenhu Liu, Doctor    +86-01-63139144    liuwh2002@yahoo.cn   
Principal Investigator: Wenhu Liu, Doctor         
Sponsors and Collaborators
Beijing Friendship Hospital
  More Information

No publications provided

Responsible Party: Wenhu Liu, Professor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT01839383     History of Changes
Other Study ID Numbers: BJFH-EC/2013-020
Study First Received: April 22, 2013
Last Updated: April 29, 2013
Health Authority: China:Capital Medical University

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014