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Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

Primary Purpose

Hyperphosphatemia, End-stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

enhanced individualised therapy

non-enhanced individualised therapy

regular intervention

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring individualised therapy, hyperphosphatemia, hemodialysis, clinical trials, restricted phosphate diet, phosphate binders

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Huashan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

enhanced individualised therapy

non-enhanced individualised therapy

regular intervention

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Serum phosphate level at the end of the trial

Secondary Outcome Measures

Serum calcium

parathyroid hormone

serum iPTH level

cost of the therapy

Full Information

NCT ID

NCT02684643

First Posted

January 28, 2016

Last Updated

February 22, 2018

Sponsor

Huashan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02684643

Brief Title

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

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperphosphatemia, End-stage Renal Disease

Keywords

individualised therapy, hyperphosphatemia, hemodialysis, clinical trials, restricted phosphate diet, phosphate binders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

enhanced individualised therapy

Arm Type

Experimental

Arm Description

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

Arm Title

non-enhanced individualised therapy

Arm Type

Experimental

Arm Description

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

Arm Title

regular intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

enhanced individualised therapy

Intervention Description

additional dialysis dosage, modification of medication and prescribed dietary plan

Intervention Type

Other

Intervention Name(s)

non-enhanced individualised therapy

Intervention Description

modified medication, prescribed dietary plan and regular three times/week dialysis dosage

Intervention Type

Other

Intervention Name(s)

regular intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Serum phosphate level at the end of the trial

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Serum calcium

Time Frame

6 weeks

Title

parathyroid hormone

Description

serum iPTH level

Time Frame

6 weeks

Title

cost of the therapy

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Huashan Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200041

Country

China

12. IPD Sharing Statement

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Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

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