The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum
Primary Purpose
Endstage Renal Disease
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
low-dose sucroferric oxyhydroxide
high-dose sucroferric oxyhydroxide
Sponsored by
About this trial
This is an interventional diagnostic trial for Endstage Renal Disease
Eligibility 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
Sites / Locations
- Ordensklinikum Linz GmbH Elisabethinen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
low-dose sucroferric oxyhydroxide
high-dose sucroferric oxyhydroxide
Arm Description
Low dose 250 mg sucroferric oxyhydroxide (PA21) per day (1x 250mg tablets/day) for 14 days.
Uniform dose 2000 mg of sucroferric oxyhydroxide (PA21) per day (4x 500mg tablets/day) for 14 days
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in Serum Phosphate
The secondary outcome is the Change of mean Serum Phosphate Levels between different study visits
Full Information
NCT ID
NCT03010072
First Posted
December 22, 2016
Last Updated
July 19, 2019
Sponsor
Prim. Priv. Doz. Dr. Daniel Cejka
Collaborators
Vifor Fresenius Medical Care Renal Pharma
1. Study Identification
Unique Protocol Identification Number
NCT03010072
Brief Title
The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum
Official Title
The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
May 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Priv. Doz. Dr. Daniel Cejka
Collaborators
Vifor Fresenius Medical Care Renal Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Patients will be randomized in a 1:1 ratio to either receive low-dose (250mg/d) PA-21 followed by high-dose (2000mg/d) PA-21 (sequence A-B) or to receive high-dose PA21 followed by low-dose PA21 (sequence B-A) with washout-phases in between. An open label design with a sub-therapeutic dose of PA21 as control treatment was chosen because creating a convincing placebo for PA21 is not feasible.
The study will start with two study visits on the 2nd and 3rd dialysis session of the week , where dialysis patients are still treated with standard of care to establish baseline values (duration: 0.5 weeks). Next will be an initial run-in wash-out phase, where all phosphate binders taken by the patient as standard of care treatment will be discontinued and no phosphate binders will be introduced. Consequently, there will be a PA21 treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another PA21 treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 days of duration. Patients will be followed up to 10.5 weeks after randomization until the last study visit of the final wash-out phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endstage Renal Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low-dose sucroferric oxyhydroxide
Arm Type
Active Comparator
Arm Description
Low dose 250 mg sucroferric oxyhydroxide (PA21) per day (1x 250mg tablets/day) for 14 days.
Arm Title
high-dose sucroferric oxyhydroxide
Arm Type
Active Comparator
Arm Description
Uniform dose 2000 mg of sucroferric oxyhydroxide (PA21) per day (4x 500mg tablets/day) for 14 days
Intervention Type
Drug
Intervention Name(s)
low-dose sucroferric oxyhydroxide
Other Intervention Name(s)
suroferric oxyhydroxide tablets, Velphoro
Intervention Description
250 mg suroferric oxyhydroxide
Intervention Type
Drug
Intervention Name(s)
high-dose sucroferric oxyhydroxide
Other Intervention Name(s)
suroferric oxyhydroxide tablets, Velphoro
Intervention Description
2000 mg suroferric oxyhydroxide
Primary Outcome Measure Information:
Title
Propensity of serum for calcification - H1
Description
The primary outcome is change in the mean T50- Test values between different study phases (wash-out/treatment/control).
Time Frame
10.5 weeks
Secondary Outcome Measure Information:
Title
Change in Serum Phosphate
Description
The secondary outcome is the Change of mean Serum Phosphate Levels between different study visits
Time Frame
10.5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Cejka, Dr.
Organizational Affiliation
Sponsor/PI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum
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