Patient preference-based phosphate binder therapy in haemodialysis patients: a feasibility study on patient satisfaction

Patient preference-based phosphate binder therapy in haemodialysis patients: a feasibility study on patient satisfaction - Triple-P

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55060

Enrollment

Registered

2021-04-07

Start date

2022-05-05

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney disease end stage renal disease

Interventions

Patients in the intervention group will use three different phosphate lowering agents consecutively in random order for 2 weeks per treatment (sevelamer, lanthanumcarbonate and sucroferric oxyhydrox

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age >= 18 years • Haemodialysis patients (since at least 3 months) • Necessity of phosphate binding therapy • Written informed consent

Exclusion criteria

Exclusion criteria: • Intolerance of one of three types of phosphate binders • Expected cessation of dialysis treatment within 6 months

Design outcomes

Primary

Measure	Time frame
Patient satisfaction with phosphate treatment measured with the Treatment Satisfaction Questionnaire for Medication (TSQM, version II).	—

Secondary

Measure	Time frame
At the end of the trial efficacy phase the following secondary endpoints will be determined: • Plasma phosphate (before the first hemodialysis session after the long interval). • Quality of life (SF-12 questionnaire) • Dialysis symptoms index (DSI) • Side effects phosphate binding therapy (questionnaire) • PTH and alkaline phosphatase levels • Adherence to the phosphate binders (questionnaire and pill count)	—

Measure

Time frame

At the end of the trial efficacy phase the following secondary endpoints will be determined: • Plasma phosphate (before the first hemodialysis session after the long interval). • Quality of life (SF-12 questionnaire) • Dialysis symptoms index (DSI) • Side effects phosphate binding therapy (questionnaire) • PTH and alkaline phosphatase levels • Adherence to the phosphate binders (questionnaire and pill count)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)