International Journal of Nephrology / 2015 / Article / Tab 5

Clinical Study

A Study to Inform the Design of a National Multicentre Randomised Controlled Trial to Evaluate If Reducing Serum Phosphate to Normal Levels Improves Clinical Outcomes including Mortality, Cardiovascular Events, Bone Pain, or Fracture in Patients on Dialysis

Table 5

Measuring trial endpoints.

Outcome measuresAssessment

Percentage of Greater Manchester kidney physicians agreeing to enter patients into a study which includes a “higher range” groupSurvey of the nephrology consultants in the Greater Manchester area

Percentage of eligible invited patients willing to be randomised into a study which includes a “higher range” groupLog of all eligible patients in the Greater Manchester area to be maintained

Percentage of patients achieving consistent control of serum phosphate in each group over a 10-month maintenance periodThis information will be obtained from the trial database

Drop-out rate from the study due to adverse events, kidney transplantation, intercurrent illness, and death; these numbers will inform the power calculation for the larger national studyThis information will be obtained from the trial database

Pill burden per patient to control serum phosphateThe total number of phosphate binding medications needed in every patient to achieve the desired range of serum phosphates will be calculated

Adherence with therapyBAASIS once every 4 weeks

Willingness of subjects to participate in Communicare patient support programmeThe number of patients willing to use the package will be documented

Mean symptom score assessed by Pittsburgh Dialysis Symptoms IndexThis will be done at the beginning, midway, and the end of the study

Incidence of major vascular events, defined as nonfatal myocardial infarction or any cardiac death, any stroke, or any arterial revascularisation excluding dialysis access proceduresThis information will be captured on the CRF and transferred to the trial database

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