Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

Not Applicable

Completed

• Conditions: Hyperphosphatemia; End-stage Renal Disease
• Interventions: Other: enhanced individualised therapy; Other: non-enhanced individualised therapy; Other: regular intervention

• Registration Number: NCT02684643
• Lead Sponsor: Huashan Hospital

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enhanced individualised therapy	enhanced individualised therapy	Patients' dialysis dosage, medication as well as dietary plan will be modified.
non-enhanced individualised therapy	non-enhanced individualised therapy	Patients' medication as well as dietary plan will be modified without alteration of dialysis dosage.
regular intervention	regular intervention	Phosphate binders and calcitriol will be prescribed and adjusted without altering patients' diet habit.

Primary Outcome Measures

Name	Time	Method
Serum phosphate level at the end of the trial	6 weeks

Secondary Outcome Measures

Name	Time	Method
Serum calcium	6 weeks
parathyroid hormone	6 weeks	serum iPTH level
cost of the therapy	6 weeks

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China