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

• Status: Completed
• Trial end date: 2019-05-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prim. Priv. Doz. Dr. Daniel Cejka
• Collaborator: Vifor Fresenius Medical Care Renal Pharma
• Treatments: Ferric Compounds

Criteria

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