Hyperphosphatemia, End-stage Renal Disease
Conditions
Keywords
individualised therapy, hyperphosphatemia, hemodialysis, clinical trials, restricted phosphate diet, phosphate binders
Brief summary
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.
Detailed description
Hyperphosphatemia in hemodialysis patients has been one of the most difficult conundrums for nephrologist for the past two decades. Elevated phosphate contributes to secondary hyperparathyroidism, elevated FGF23 levels, and vascular calcification, which in turn predispose to mortality in this population. Current guidelines recommend limiting dietary phosphate intake, strengthening dialysis and using phosphate binders as three therapies for treatment of hyperphosphatemia. Yet exact clinical implication remains ambiguous: how intense restricted phosphate intake should be and how dosage of phosphate binders and dialysis should be adjusted accordingly. Thus, treatments of hyperphosphatemia have not been effective enough, but appear to be refractory. In the current study, the investigators designed individualized phosphate-lowering therapy based on each patient's phosphate-clearing ability, in order to observe and compare the efficacy and cost-effectiveness of the individualized therapy and the regular guideline-recommended therapy.
Interventions
OTHERenhanced individualised therapy
additional dialysis dosage, modification of medication and prescribed dietary plan
OTHERnon-enhanced individualised therapy
modified medication, prescribed dietary plan and regular three times/week dialysis dosage
OTHERregular intervention
Phosphate binders and calcitriol would be prescribed according to the guidelines. Phosphate binders included in the study are calcium acetate, calcium carbonate or sevelamer. Dosage is based on patients serum phosphate and calcium level. Calcitriol prescribed in the study is Rocaltrol and the dosage is based on PTH, serum phosphate and calcium level. Patients' diet habit will not be altered.
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum phosphate level at the end of the trial | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum calcium | 6 weeks | — |
| parathyroid hormone | 6 weeks | serum iPTH level |
| cost of the therapy | 6 weeks | — |
Countries
China
Outcome results
None listed