Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

NCT ID: NCT02684643

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-04-30

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.

Conditions

Hyperphosphatemia; End-stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

enhanced individualised therapy

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

Group Type: EXPERIMENTAL

enhanced individualised therapy

Intervention Type: OTHER

additional dialysis dosage, modification of medication and prescribed dietary plan

non-enhanced individualised therapy

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

Group Type: EXPERIMENTAL

non-enhanced individualised therapy

Intervention Type: OTHER

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

regular intervention

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

Group Type: EXPERIMENTAL

regular intervention

Intervention Type: OTHER

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.

Interventions

enhanced individualised therapy

additional dialysis dosage, modification of medication and prescribed dietary plan

Intervention Type: OTHER

non-enhanced individualised therapy

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

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen Jing

Chief Physician of Division of Nephrology, Professor, Associate Director of Division of Nephrology and Director of Dialysis Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Huashan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type: DERIVED

PMID: 40576086 (View on PubMed)

Other Identifiers

KY2015-271

Identifier Type: -

Identifier Source: org_study_id