Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Huashan Hospital
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Serum phosphate level at the end of the trial
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
enhanced individualised therapy
Patients' dialysis dosage, medication as well as dietary plan will be modified.
Intervention: enhanced individualised therapy (Other)
non-enhanced individualised therapy
Patients' medication as well as dietary plan will be modified without alteration of dialysis dosage.
Intervention: non-enhanced individualised therapy (Other)
regular intervention
Phosphate binders and calcitriol will be prescribed and adjusted without altering patients' diet habit.
Intervention: regular intervention (Other)
Outcomes
Primary Outcomes
Serum phosphate level at the end of the trial
Time Frame: 6 weeks
Secondary Outcomes
- cost of the therapy(6 weeks)
- Serum calcium(6 weeks)
- parathyroid hormone(6 weeks)
Investigators
Chen Jing
Chief Physician of Division of Nephrology, Professor, Associate Director of Division of Nephrology and Director of Dialysis Centre
Huashan Hospital