Clinical trial NCT02684643: Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients
Official title: Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperphosphatemia
End-stage Renal Disease
Keywords: individualised therapy
hyperphosphatemia
hemodialysis
clinical trials
restricted phosphate diet
phosphate binders
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum phosphate level at the end of the trial
timeFrame: 6 weeks
Secondary outcomes:
measure: Serum calcium
timeFrame: 6 weeks
measure: parathyroid hormone
timeFrame: 6 weeks
measure: cost of the therapy
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References: