NCT02684643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

January 28, 2016

Last Update Submit

February 22, 2018

Conditions

HyperphosphatemiaEnd-stage Renal Disease

Keywords

individualised therapyhyperphosphatemiahemodialysisclinical trialsrestricted phosphate dietphosphate binders

Outcome Measures

Primary Outcomes (1)

  • Serum phosphate level at the end of the trial

    6 weeks

Secondary Outcomes (3)

  • Serum calcium

    6 weeks

  • parathyroid hormone

    6 weeks

  • cost of the therapy

    6 weeks

Study Arms (3)

enhanced individualised therapy

EXPERIMENTAL

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

Other: enhanced individualised therapy

non-enhanced individualised therapy

EXPERIMENTAL

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

Other: non-enhanced individualised therapy

regular intervention

EXPERIMENTAL

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

Other: regular intervention

Interventions

enhanced individualised therapyOTHER

additional dialysis dosage, modification of medication and prescribed dietary plan

enhanced individualised therapy
non-enhanced individualised therapyOTHER

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

non-enhanced individualised therapy
regular interventionOTHER

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.

regular intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200041, China

Location

Related Publications (1)

  • 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.

    PMID: 40576086DERIVED

MeSH Terms

Conditions

HyperphosphatemiaKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician of Division of Nephrology, Professor, Associate Director of Division of Nephrology and Director of Dialysis Centre

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 18, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

February 26, 2018

Record last verified: 2018-02

Locations

CN(1)