Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

Conditions
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Hyperphosphatemia, End-stage Renal Disease

Intervention / Treatment
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* Other: enhanced individualised therapy
* Other: non-enhanced individualised therapy
* Other: regular intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enhanced individualised therapy<br>Patients' dialysis dosage, medication as well as dietary plan will be modified. | Other: enhanced individualised therapy<br>* additional dialysis dosage, modification of medication and prescribed dietary plan<br>|
| Experimental: non-enhanced individualised therapy<br>Patients' medication as well as dietary plan will be modified without alteration of dialysis dosage. | Other: non-enhanced individualised therapy<br>* modified medication, prescribed dietary plan and regular three times/week dialysis dosage<br>|
| Experimental: regular intervention<br>Phosphate binders and calcitriol will be prescribed and adjusted without altering patients' diet habit. | Other: regular intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum phosphate level at the end of the trial |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum calcium |  | 6 weeks | 
| parathyroid hormone | serum iPTH level | 6 weeks | 
| cost of the therapy |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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individualised therapy, hyperphosphatemia, hemodialysis, clinical trials, restricted phosphate diet, phosphate binders