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

The Effect of Phosphate Lowering using sucroferric oxyhydroxide (PA21) on Calcification Propensity of Serum – a randomized, controlled, open-label, cross-over trial - PA21-T50-CKD5D

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004789-24-AT

Enrollment

Registered

2017-01-31

Start date

2017-03-10

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

end stage renal disease

Interventions

Trade Name: Velphoro Product Name: sucroferric oxyhydroxide Product Code: PA21 Pharmaceutical Form: Chewable tablet INN or Proposed INN: SUCROFERRIC OXYHYDROXIDE Other descriptive name: SUCROFERRIC O

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary outcome is change in the mean T50 values between different study phases (wash-out/treatment/control).;Secondary Objective: The secondary outcome is change of mean serum phosphate levels between different study phases.;Primary end point(s): The primary endpoint is the change in T50 value;Timepoint(s) of evaluation of this end point: every studyvisit	—

Secondary

Measure	Time frame
Secondary end point(s): change of mean serum phosphate levels ;Timepoint(s) of evaluation of this end point: every studyvisit	—

Countries

Austria

Contacts

Public ContactClinical Trial Administration

Ordensklinikum Linz, Krankenhaus der Elisabethinen Linz GmbH, III. Interne

alexandra.dumfarth@ordensklinikum.at004373276764302

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026