CompletedPhase 2

The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum

Austria40 participantsStarted 2017-06-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Propensity of serum for calcification - H1

Timeframe: 10.5 weeks

Trial details

NCT IDNCT03010072

SponsorPrim. Priv. Doz. Dr. Daniel Cejka

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-31

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