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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-09

Study Completion Date

2019-05-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endstage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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low-dose sucroferric oxyhydroxide

Low dose 250 mg sucroferric oxyhydroxide (PA21) per day (1x 250mg tablets/day) for 14 days.

Group Type ACTIVE_COMPARATOR

low-dose sucroferric oxyhydroxide

Intervention Type DRUG

250 mg suroferric oxyhydroxide

high-dose sucroferric oxyhydroxide

Uniform dose 2000 mg of sucroferric oxyhydroxide (PA21) per day (4x 500mg tablets/day) for 14 days

Group Type ACTIVE_COMPARATOR

high-dose sucroferric oxyhydroxide

Intervention Type DRUG

2000 mg suroferric oxyhydroxide

Interventions

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low-dose sucroferric oxyhydroxide

250 mg suroferric oxyhydroxide

Intervention Type DRUG

high-dose sucroferric oxyhydroxide

2000 mg suroferric oxyhydroxide

Intervention Type DRUG

Other Intervention Names

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suroferric oxyhydroxide tablets Velphoro suroferric oxyhydroxide tablets Velphoro

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No