The Effect of Phosphate Lowering in blood using medication called sucroferric oxyhydroxide (PA21) on Calcification Propensity of the blood– a clinical Trial in which people taking part are put into one or other group at random, the treatment is compared to a control treatment , open-label, cross-over trial

Phase 1

• Conditions: end stage renal disease; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2016-004789-24-AT
• Lead Sponsor: Ordensklinikum Linz, Krankenhaus der Elisabethinen Linz GmbH, III. Interne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-31
• Last Update Posted: 23 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Adults = 18 years old
•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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)
•PTH >800 pg/ml
•Parathyreoidectomy planned or expected
•Significant GI or hepatic disorders
•Hypercalcemia (total sCa >2.6 mmol/l) at screening
•Antacids containing aluminum, calcium, magnesium or bicarbonate
•Oral iron treatments/supplements
•Pregnant and nursing (lactating) women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified