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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

April 22, 2013
April 29, 2013
June 2013
June 2015   (final data collection date for primary outcome measure)
  • 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
  • death [ Time Frame: 24months ] [ Designated as safety issue: No ]
  • cardio-cerebral vascular disease((defined as heart failure, myocardial infarction and stroke) [ Time Frame: 24months ] [ Designated as safety issue: No ]
  • newly nontraumatic bone fracture [ Time Frame: 24months ] [ Designated as safety issue: No ]
  • secondary hyperparathyroidism uncontrolled by medicine [ Time Frame: 24months ] [ Designated as safety issue: No ]
  • valvular or vascular calcification [ Time Frame: 24months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01839383 on ClinicalTrials.gov Archive Site
admission or emergency observation [ Time Frame: 24months ] [ Designated as safety issue: No ]
incidence of admission or emergency observation
admission or emergency observation [ Time Frame: 24months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Mineral-bone Metabolism
Other: different dialysate calcium concentration
  • Active Comparator: DCa1.25
    using dialysate calcium concentration 1.25 mmol/L(DCa1.25)
    Intervention: Other: different dialysate calcium concentration
  • Active Comparator: DCa1.5
    using dialysate calcium concentration 1.5mmol/L
    Intervention: Other: different dialysate calcium concentration
  • Active Comparator: DCa1.75
    using dialysate calcium concentration 1.75mmol/L
    Intervention: Other: different dialysate calcium concentration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
90
Not Provided
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
China
 
NCT01839383
BJFH-EC/2013-020
Not Provided
Wenhu Liu, Beijing Friendship Hospital
Beijing Friendship Hospital
Not Provided
Not Provided
Beijing Friendship Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP