The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedStudy Start
First participant enrolled
June 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2019
CompletedJuly 22, 2019
July 1, 2019
1.6 years
December 22, 2016
July 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Propensity of serum for calcification - H1
The primary outcome is change in the mean T50- Test values between different study phases (wash-out/treatment/control).
10.5 weeks
Secondary Outcomes (1)
Change in Serum Phosphate
10.5 weeks
Study Arms (2)
low-dose sucroferric oxyhydroxide
ACTIVE COMPARATORLow dose 250 mg sucroferric oxyhydroxide (PA21) per day (1x 250mg tablets/day) for 14 days.
high-dose sucroferric oxyhydroxide
ACTIVE COMPARATORUniform dose 2000 mg of sucroferric oxyhydroxide (PA21) per day (4x 500mg tablets/day) for 14 days
Interventions
250 mg suroferric oxyhydroxide
2000 mg suroferric oxyhydroxide
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020, Austria
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Cejka, Dr.
Sponsor/PI
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prim. Priv. Doz. Dr.
Study Record Dates
First Submitted
December 22, 2016
First Posted
January 4, 2017
Study Start
June 9, 2017
Primary Completion
December 31, 2018
Study Completion
May 10, 2019
Last Updated
July 22, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share