CClinicalTrials.gg
Status unknownNCT01839383Updated Apr 30, 2013

The Effects of Different Dialysate Calcium Concentration

An interventional study of different dialysate calcium concentration in Mineral-bone Metabolism, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-04-30.

Sponsored by Beijing Friendship Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Mineral-bone Metabolism
03

In context

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • 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

Interventions

  • Otherdifferent dialysate calcium concentration
06

What researchers measure

Primary outcomes

  1. death

    incidence of death

    Time frame: 24months

  2. cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke)

    incidence of cardio-cerebral vascular disease

    Time frame: 24months

  3. newly nontraumatic bone fracture

    incidence of newly nontraumatic bone fracture

    Time frame: 24months

  4. secondary hyperparathyroidism uncontrolled by medicine

    incidence of secondary hyperparathyroidism uncontrolled by medicine

    Time frame: 24months

  5. valvular or vascular calcification

    incidence of valvular or vascular calcification

    Time frame: 24months

Secondary outcomes

  1. admission or emergency observation

    incidence of admission or emergency observation

    Time frame: 24months

07

Study locations

1 site
  • Beijing Friendship hospital
    Beijing, Beijing 100050, China
    • Wenhu Liu, Doctor · Contact · liuwh2002@yahoo.cn · +86-01-63139144
    • Wenhu Liu, Doctor · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01839383
Lead sponsor
Beijing Friendship Hospital
Responsible party
Wenhu Liu (Professor, Beijing Friendship Hospital) — Principal investigator
First posted
Apr 24, 2013
Start date
Jun 2013
Primary completion
Jun 2015 (estimated)
Last update
Apr 30, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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