End-stage Renal Disease Clinical Trial
Official title:
Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients
Verified date | February 2018 |
Source | Huashan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to study and compare the efficacy and cost-effectiveness of individualized phosphate-lowering therapy in comparison with regular guideline-recommended therapy.
Status | Completed |
Enrollment | 72 |
Est. completion date | April 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - aged 18-70 years' old - dialysis vintage more than 3 months on maintenance hemodialysis patients - using internal arteriovenous fistula - S[P] > 1.45 mmol/l, PTH (parathyroid hormone, PTH) < 900 ng/ml - no residual renal function (RRF) - stable dietary habit - clear consciousness and capable of communication - willingness to give written consent and comply with the study protocol Exclusion Criteria: - severe infection, anemia (Hb < 60 g/L), hypoproteinemia (Alb < 30 g/L) - pregnancy, lactating women - history of severe coexisting diseases such as, but not limited to, chronic liver disease, myocardial infection, cerebrovascular accident, malignant hypertension - history of malignancy - participation in other dietary, drug-related, or any other clinical trials within 1 month - history of complications related to elevated S[P] such as, but not limited to primary hypoparathyroidism, type II vitamin D dependent rickets - history of non-compliance - intolerance to the individualized therapy - in use of calcitonin and diphosphonate |
Country | Name | City | State |
---|---|---|---|
China | Huashan Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum phosphate level at the end of the trial | 6 weeks | ||
Secondary | Serum calcium | 6 weeks | ||
Secondary | parathyroid hormone | serum iPTH level | 6 weeks | |
Secondary | cost of the therapy | 6 weeks |
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