Patient preference-based phosphate binding therapy will improve patient’s satisfaction with the treatment leading to higher adherence and subsequently to an improved serum phosphate control. In this pilot study we will test the feasibility of a…
ID
Bron
Verkorte titel
Aandoening
Chronic Kidney Disease, end-stage renal disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Patient satisfaction with phosphate treatment measured with the Treatment Satisfaction Questionnaire for Medication (TSQM, version II).
Achtergrond van het onderzoek
Hyperphosphatemia is associated with increased mortality and (cardiovascular) morbidity, especially in patients on dialysis. In addition to dietary interventions and optimization of dialysis schemes, most dialysis patients also require phosphate binding medication. However, a substantial proportion of these patients do not attain adequate phosphate control due to non-adherence. Importantly, there are no firm scientific data that dictate which phosphate binder should be used as first line intervention with the possible exception of higher doses of calcium containing phosphate binders, which are associated with a higher mortality risk. The most effective therapy might be the therapy that best fits the preferences of the individual patient, i.e. the binder that is best tolerated and is the easiest to use in daily routine of an individual patient. In this pilot study we will test the feasibility of a strategy in which patient preference, after a short exposure to treatment options, determines the choice for a specific phosphate binder and whether this improves patient satisfaction with treatment and subsequently leads to higher adherence and improved phosphate control.
Doel van het onderzoek
Patient preference-based phosphate binding therapy will improve patient’s satisfaction with the treatment leading to higher adherence and subsequently to an improved serum phosphate control. In this pilot study we will test the feasibility of a strategy in which patient preference, after a short exposure to treatment options, determines the choice for a specific phosphate binder.
Onderzoeksopzet
Baseline measurement will be followed by a 2 weeks wash-out period. The intervention periods consists of 22 weeks (6 weeks trial periods (3*2 wks), 10 weeks up titration and 4 weeks trial efficacy phase.
Onderzoeksproduct en/of interventie
Patients will use three different phosphate lowering agents consecutively in random order for 2 weeks per treatment: sevelamer, lanthanumcarbonate and sucroferric oxyhydroxide. After these trial periods the patient will choose their initial treatment followed by a period of 10 weeks in which treatment will be up titrated to reach the phosphate goal (i.e. <1.8 mmol/L). End points will be measured after a final 4 weeks “trial efficacy phase”.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age ≥ 18 years
- Haemodialysis patients (since at least 3 months)
- Necessity of phosphate binding therapy
- Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Intolerance to one of three types of phosphate binders
- Expected cessation of dialysis treatment within 6 months
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
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NTR-new | NL8400 |
Ander register | METc VUmc : pending |