Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

End-stage Renal Disease Clinical Trial

Official title:

Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684643
• Other study ID #: KY2015-271
• Status: Completed
• Phase: N/A
• First received: January 28, 2016
• Last updated: February 22, 2018
• Start date: January 2016
• Est. completion date: April 2017

Study information

• Verified date: February 2018
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Hyperphosphatemia
• Kidney Failure, Chronic

Intervention

Other:
• enhanced individualised therapy
additional dialysis dosage, modification of medication and prescribed dietary plan
• non-enhanced individualised therapy
modified medication, prescribed dietary plan and regular three times/week dialysis dosage
• 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.

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum phosphate level at the end of the trial		6 weeks
Secondary	Serum calcium		6 weeks
Secondary	parathyroid hormone	serum iPTH level	6 weeks
Secondary	cost of the therapy		6 weeks