Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

Fudan University

Status: Completed

Conditions: Hyperphosphatemia; End-stage Renal Disease

Treatments: Other: non-enhanced individualised therapy; Other: enhanced individualised therapy; Other: regular intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02684643

KY2015-271

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

enhanced individualised therapy

Experimental group

Description:

Patients' dialysis dosage, medication as well as dietary plan will be modified.

Treatment:

Other: enhanced individualised therapy

non-enhanced individualised therapy

Experimental group

Description:

Patients' medication as well as dietary plan will be modified without alteration of dialysis dosage.

Treatment:

Other: non-enhanced individualised therapy

regular intervention

Experimental group

Description:

Phosphate binders and calcitriol will be prescribed and adjusted without altering patients' diet habit.

Treatment:

Other: regular intervention