Endstage Renal DiseasePhase 2NCT03010072
The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum
A Phase 2 study testing low-dose sucroferric oxyhydroxide and high-dose sucroferric oxyhydroxide in people with Endstage Renal Disease, run by Prim. Priv. Doz. Dr. Daniel Cejka at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endstage Renal Disease
- What is being tested?
- low-dose sucroferric oxyhydroxide and high-dose sucroferric oxyhydroxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 9 Jun 2017to 10 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Antacids containing aluminum, calcium, magnesium or bicarbonate
- Oral iron treatments/supplements
- Pregnant and nursing (lactating) women
Trial locations and contacts
1 site in 1 country.
Austria1 site
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020
About this study
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.
Read the 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.
- Conditions
- Endstage Renal Disease
- Being tested
- low-dose sucroferric oxyhydroxide, high-dose sucroferric oxyhydroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose sucroferric oxyhydroxideDrug
Also called suroferric oxyhydroxide tablets, Velphoro
250 mg suroferric oxyhydroxide
high-dose sucroferric oxyhydroxideDrug
Also called suroferric oxyhydroxide tablets, Velphoro
2000 mg suroferric oxyhydroxide
| Study group | Role | What they receive |
|---|---|---|
| low-dose sucroferric oxyhydroxide | Active comparator | Low dose 250 mg sucroferric oxyhydroxide (PA21) per day (1x 250mg tablets/day) for 14 days. Receives: Drug: low-dose sucroferric oxyhydroxide |
| high-dose sucroferric oxyhydroxide | Active comparator | Uniform dose 2000 mg of sucroferric oxyhydroxide (PA21) per day (4x 500mg tablets/day) for 14 days Receives: Drug: high-dose sucroferric oxyhydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10.5 weeks
Secondary outcomes (1)
Change in Serum Phosphate
The secondary outcome is the Change of mean Serum Phosphate Levels between different study visits
Measured: 10.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start9 Jun 2017
- Primary completion31 Dec 2018
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endstage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prim. Priv. Doz. Dr. Daniel Cejka
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Fresenius Medical Care Renal Pharma
- Responsible party
- Sponsor-investigator, Prim. Priv. Doz. Dr. Daniel Cejka, Elisabethinen Hospital
- Investigators
- Daniel Cejka, Dr., Principal investigator, Sponsor/PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010072
- Sponsor's protocol ID
- PA21-T50-CKD5D
- Status last verified
- Jul 2019
- First submitted
- 22 Dec 2016
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum
- ClinicalTrials.gov ID
- NCT03010072
- Acronym / sponsor ID
- PA21-T50-CKD5D
- Conditions
- Endstage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prim. Priv. Doz. Dr. Daniel CejkaUniversity, hospital or other
- Collaborators
- Vifor Fresenius Medical Care Renal Pharma
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-dose sucroferric oxyhydroxide | Active comparator | Drug: low-dose sucroferric oxyhydroxideLow dose 250 mg sucroferric oxyhydroxide (PA21) per day (1x 250mg tablets/day) for 14 days. |
| high-dose sucroferric oxyhydroxide | Active comparator | Drug: high-dose sucroferric oxyhydroxideUniform dose 2000 mg of sucroferric oxyhydroxide (PA21) per day (4x 500mg tablets/day) for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-dose sucroferric oxyhydroxideAlso: suroferric oxyhydroxide tablets, Velphoro250 mg suroferric oxyhydroxide | Drug | low-dose sucroferric oxyhydroxide |
| high-dose sucroferric oxyhydroxideAlso: suroferric oxyhydroxide tablets, Velphoro2000 mg suroferric oxyhydroxide | Drug | high-dose sucroferric oxyhydroxide |
Primary outcome
Propensity of serum for calcification - H1
Time frame: 10.5 weeks
The primary outcome is change in the mean T50- Test values between different study phases (wash-out/treatment/control).
1 secondary outcome
Change in Serum Phosphate
Time frame: 10.5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Cejka, Dr. principal investigator
Sponsor/PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing low-dose sucroferric oxyhydroxide and high-dose sucroferric oxyhydroxide in people with Endstage Renal Disease, run by Prim. Priv. Doz. Dr. Daniel Cejka at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propensity of serum for calcification - H1 (time frame: 10.5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.