Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

Huashan Hospital72 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperphosphatemia End-stage Renal Disease

Interventions

enhanced individualised therapyOTHER

additional dialysis dosage, modification of medication and prescribed dietary plan

non-enhanced individualised therapyOTHER

modified medication, prescribed dietary plan and regular three times/week dialysis dosage

regular interventionOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Huashan Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Serum phosphate level at the end of the trial

Time frame: 6 weeks

Secondary Outcomes

Serum calcium

Time frame: 6 weeks

parathyroid hormone

serum iPTH level

Time frame: 6 weeks

cost of the therapy

Time frame: 6 weeks

Data from ClinicalTrials.gov

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