Suspended

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

What is being tested

different dialysate calcium concentration

+ different dialysate calcium concentration

Other

Who is being recruted

From 18 to 65 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: June 2013

See protocol details

Summary

Principal SponsorBeijing Friendship Hospital

Study ContactWenhu Liu, DoctorMore contacts

Last updated: April 30, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01839383

Principal SponsorBeijing Friendship Hospital

Study ContactWenhu Liu, DoctorMore contacts

Last updated: April 30, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate

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

1 exclusion criteria prevent from participating

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

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

using dialysate calcium concentration 1.25 mmol/L(DCa1.25)

Group II

Active Comparator

using dialysate calcium concentration 1.5mmol/L

Group III

Active Comparator

using dialysate calcium concentration 1.75mmol/L

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Beijing Friendship hospital

Beijing, ChinaOpen Beijing Friendship hospital in Google Maps

SuspendedOne Study Center