Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia; End-stage Renal Disease
• Intervention / Treatment: Other: enhanced individualised therapy; Other: non-enhanced individualised therapy; Other: regular intervention

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200041
      • Huashan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: enhanced individualised therapy; Patients' dialysis dosage, medication as well as dietary plan will be modified.	Other: enhanced individualised therapy; additional dialysis dosage, modification of medication and prescribed dietary plan
Experimental: non-enhanced individualised therapy; Patients' medication as well as dietary plan will be modified without alteration of dialysis dosage.	Other: non-enhanced individualised therapy; modified medication, prescribed dietary plan and regular three times/week dialysis dosage
Experimental: regular intervention; Phosphate binders and calcitriol will be prescribed and adjusted without altering patients' diet habit.	Other: regular intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum phosphate level at the end of the trial	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum calcium		6 weeks
parathyroid hormone	serum iPTH level	6 weeks
cost of the therapy		6 weeks

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: clinical trials; hemodialysis; hyperphosphatemia; individualised therapy; restricted phosphate diet; phosphate binders
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Phosphorus Metabolism Disorders; Kidney Failure, Chronic; Hyperphosphatemia
• Other Study ID Numbers: KY2015-271