Mineral-bone MetabolismNCT01839383
The Effects of Different Dialysate Calcium Concentration
A study testing different dialysate calcium concentration in people with Mineral-bone Metabolism, run by Beijing Friendship Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mineral-bone Metabolism
- What is being tested?
- different dialysate calcium concentration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65, maintenance hemodialysis, dialytic vintage ≥12 months, iPTH 150-300pg/ml, serum calcium<2.5mmol/L, serum calcium<2.5mmol/L.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship hospital
Beijing, Beijing Municipality, 100050
Wenhu Liu, Doctor, +86-01-63139144, liuwh2002@yahoo.cn
Wenhu Liu, Doctor
About this study
Official title: 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.
- Conditions
- Mineral-bone Metabolism
- Being tested
- different dialysate calcium concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different dialysate calcium concentrationOther
| Study group | Role | What they receive |
|---|---|---|
| DCa1.25 | Active comparator | using dialysate calcium concentration 1.25 mmol/L(DCa1.25) Receives: Other: different dialysate calcium concentration |
| DCa1.5 | Active comparator | using dialysate calcium concentration 1.5mmol/L Receives: Other: different dialysate calcium concentration |
| DCa1.75 | Active comparator | using dialysate calcium concentration 1.75mmol/L Receives: Other: different dialysate calcium concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
incidence of death
Measured: 24months
cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke)
incidence of cardio-cerebral vascular disease
Measured: 24months
newly nontraumatic bone fracture
incidence of newly nontraumatic bone fracture
Measured: 24months
secondary hyperparathyroidism uncontrolled by medicine
incidence of secondary hyperparathyroidism uncontrolled by medicine
Measured: 24months
valvular or vascular calcification
incidence of valvular or vascular calcification
Measured: 24months
Secondary outcomes (1)
admission or emergency observation
incidence of admission or emergency observation
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mineral-bone MetabolismStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenhu Liu, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839383
- Sponsor's protocol ID
- BJFH-EC/2013-020
- Status last verified
- Apr 2013
- First submitted
- 22 Apr 2013
- Last updated
- 30 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Dialysate Calcium Concentration on Mineral-bone Metabolism in Chinese Patients on Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT01839383
- Acronym / sponsor ID
- BJFH-EC/2013-020
- Conditions
- Mineral-bone Metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (estimated)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DCa1.25 | Active comparator | Other: different dialysate calcium concentrationusing dialysate calcium concentration 1.25 mmol/L(DCa1.25) |
| DCa1.5 | Active comparator | Other: different dialysate calcium concentrationusing dialysate calcium concentration 1.5mmol/L |
| DCa1.75 | Active comparator | Other: different dialysate calcium concentrationusing dialysate calcium concentration 1.75mmol/L |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65, maintenance hemodialysis, dialytic vintage ≥12 months, iPTH 150-300pg/ml, serum calcium<2.5mmol/L, serum calcium<2.5mmol/L.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| different dialysate calcium concentration | Other | DCa1.25, DCa1.5, DCa1.75 |
Primary outcome
death
Time frame: 24months
incidence of death
cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke)
Time frame: 24months
incidence of cardio-cerebral vascular disease
newly nontraumatic bone fracture
Time frame: 24months
incidence of newly nontraumatic bone fracture
secondary hyperparathyroidism uncontrolled by medicine
Time frame: 24months
incidence of secondary hyperparathyroidism uncontrolled by medicine
valvular or vascular calcification
Time frame: 24months
incidence of valvular or vascular calcification
1 secondary outcome
admission or emergency observation
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different dialysate calcium concentration in people with Mineral-bone Metabolism, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 24months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.