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NCT Number: NCT02684643

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

enhanced individualised therapy

Other

additional dialysis dosage, modification of medication and prescribed dietary plan

non-enhanced individualised therapy

Other

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

regular intervention

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.

Primary outcomes

  1. Serum phosphate level at the end of the trial

    Time frame: 6 weeks

Secondary outcomes

  1. Serum calcium

    Time frame: 6 weeks

  2. parathyroid hormone

    Time frame: 6 weeks

    serum iPTH level

  3. cost of the therapy

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 18, 2016
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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