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

Sponsor
Prim. Priv. Doz. Dr. Daniel Cejka (Other)
Overall Status
Completed
CT.gov ID
NCT03010072
Collaborator
Vifor Fresenius Medical Care Renal Pharma (Industry)
40
Enrollment
1
Location
2
Arms
23
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: low-dose sucroferric oxyhydroxide
  • Drug: high-dose sucroferric oxyhydroxide
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum
Actual Study Start Date :
Jun 9, 2017
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
May 10, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: low-dose sucroferric oxyhydroxide

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

Drug: low-dose sucroferric oxyhydroxide
250 mg suroferric oxyhydroxide
Other Names:
  • suroferric oxyhydroxide tablets
  • Velphoro

    		•
    Active Comparator: high-dose sucroferric oxyhydroxide

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

    Drug: high-dose sucroferric oxyhydroxide
    2000 mg suroferric oxyhydroxide
    Other Names:
  • suroferric oxyhydroxide tablets
  • Velphoro

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Propensity of serum for calcification - H1 [10.5 weeks]

      The primary outcome is change in the mean T50- Test values between different study phases (wash-out/treatment/control).

    Secondary Outcome Measures

    1. Change in Serum Phosphate [10.5 weeks]

      The secondary outcome is the Change of mean Serum Phosphate Levels between different study visits

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ordensklinikum Linz GmbH Elisabethinen Linz Upper Austria Austria 4020

    Sponsors and Collaborators

    • Prim. Priv. Doz. Dr. Daniel Cejka
    • Vifor Fresenius Medical Care Renal Pharma

    Investigators

    • Principal Investigator: Daniel Cejka, Dr., Sponsor/PI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prim. Priv. Doz. Dr. Daniel Cejka, Prim. Priv. Doz. Dr., Elisabethinen Hospital
    ClinicalTrials.gov Identifier:
    NCT03010072
    Other Study ID Numbers:
    • PA21-T50-CKD5D
    First Posted:
    Jan 4, 2017
    Last Update Posted:
    Jul 22, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Kidney Failure, Chronic
    Ferric Compounds

    Study Results

    No Results Posted as of Jul 22, 2019