Endstage Renal Disease
Conditions
Brief summary
This is a single-center, prospective, open-label, controlled, randomized, cross-over study in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with hyperphosphatemia.
Detailed description
Patients will be randomized in a 1:1 ratio to either receive low-dose (250mg/d) PA-21 followed by high-dose (2000mg/d) PA-21 (sequence A-B) or to receive high-dose PA21 followed by low-dose PA21 (sequence B-A) with washout-phases in between. An open label design with a sub-therapeutic dose of PA21 as control treatment was chosen because creating a convincing placebo for PA21 is not feasible. The study will start with two study visits on the 2nd and 3rd dialysis session of the week , where dialysis patients are still treated with standard of care to establish baseline values (duration: 0.5 weeks). Next will be an initial run-in wash-out phase, where all phosphate binders taken by the patient as standard of care treatment will be discontinued and no phosphate binders will be introduced. Consequently, there will be a PA21 treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another PA21 treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 days of duration. Patients will be followed up to 10.5 weeks after randomization until the last study visit of the final wash-out phase.
Interventions
DRUGlow-dose sucroferric oxyhydroxide
250 mg suroferric oxyhydroxide
DRUGhigh-dose sucroferric oxyhydroxide
2000 mg suroferric oxyhydroxide
Sponsors
Vifor Fresenius Medical Care Renal Pharma
Prim. Priv. Doz. Dr. Daniel Cejka
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prevalent patients (≥ 3 months on dialysis) treated with thrice weekly hemodialysis (HD) or hemodiafiltration (HDF) * Hyperphosphatemia (serum phosphate \> upper limit of normal within the last 3 months) or current phosphate binder use * No use or constant dose of vitamin D and/or calcimimetics for ≥2 weeks
Exclusion criteria
* Allergy to sucroferric oxyhydroxide (PA21), to other ingredients of Velphoro or to any iron-medication * Current or history of calciphylaxis (calcific uremic arteriolopathy - CUA) * parathormone \>800 pg/ml * Parathyreoidektomie planned or expected * Significant GI or hepatic disorders * Hypercalcemia (total serum calcium \>2.6 mmol/l) at screening * Antacids containing aluminum, calcium, magnesium or bicarbonate * Oral iron treatments/supplements * Pregnant and nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Propensity of serum for calcification - H1 | 10.5 weeks | The primary outcome is change in the mean T50- Test values between different study phases (wash-out/treatment/control). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Phosphate | 10.5 weeks | The secondary outcome is the Change of mean Serum Phosphate Levels between different study visits |
Countries
Austria
Outcome results
None listed