HyperphosphatemiaVERIFIENCT02687594
Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis (HD) or Peritoneal Dialysis (PD)
An observational study of Hyperphosphatemia, run by Vifor Fresenius Medical Care Renal Pharma at 7 sites in 7 countries.
Trial summary
An oral highly potent P binder Velphoro is a mixture of polynuclear iron(III) oxyhydroxide, sucrose, and starches. It was well tolerated in the clinical development program. The approved indication in the European Union (EU) is to control serums phosphorus (sP) levels in adult CKD (Chronic kidney disease) patients on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- sucroferric oxyhydroxide
- How many people
- 1,400 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 6 Apr 2016to 6 Apr 2019
- Phase
- Observational
- 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
Study population: Male or female patients with a diagnosis of hyperphosphataemia who are due to be treated with Velphoro according to the product's Summary of Product Characteristics (SmPC) are eligible for this non-interventional study.
Who may be able to join
- Age ≥18 years
- Signed informed consent
- Indication for Velphoro treatment in accordance with the SmPC
- Prevalent dialysis patients with a dialysis vintage of at least 6 months (HD or PD)
- Treatment-naïve or pre-treated with anti-hyperphosphataemic therapy
Who cannot join
- Prior participation in this NIS (Non-Interventional Study)
- Parallel participation in an interventional study
- Enrolment in a prior clinical trial with Velphoro
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis or Peritoneal Dialysis
An oral highly potent P binder Velphoro is a mixture of polynuclear iron(III) oxyhydroxide, sucrose, and starches. It was well tolerated in the clinical development program. The approved indication in the European Union (EU) is to control serums phosphorus (sP) levels in adult CKD (Chronic kidney disease) patients on HD (Haemodialysis) or PD (Peritoneal dialysis).
It is of major interest to observe the drug in daily use outside of controlled trial settings. The Marketing Authorisation Holder wishes to obtain further systematic data within a non-interventional study to investigate short and long-term safety.
Effectiveness and Treatment adherence during real-life use will be evaluated.
- Conditions
- Hyperphosphatemia
- Being tested
- sucroferric oxyhydroxide
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sucroferric oxyhydroxideDrug
Also called PA21 (Velphoro)
The non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by a sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour.
| Study group | Role | What they receive |
|---|---|---|
| single group | sucroferric oxyhydroxide Receives: Drug: sucroferric oxyhydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Drug Reactions (ADRs)
Measured: through study completion, up to 42 months
Proportion of Adverse Drug Reactions (ADRs)
Measured: through study completion, up to 42 months
Secondary outcomes (3)
Patient Reported Outcome questionnaire - Adherence to Velphoro based on the standard Morisky questionnaire
Patient reported outcomes will be evaluated by descriptive statistics
Measured: through study completion, up to 42 months
Patient Reported Outcome questionnaire - Perceived Pill based on the ACTG questionnaire
Patient reported outcomes will be evaluated by descriptive statistics
Measured: through study completion, up to 42 months
Patient Reported Outcome questionnaire - Treatment satisfaction based on the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Patient reported outcomes will be evaluated by descriptive statistics
Measured: through study completion, up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study start6 Apr 2016
- Primary completion6 Apr 2019
- Study completion6 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphosphatemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Fresenius Medical Care Renal Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastian Walpen, Dr., Study chair, Vifor Fresenius Medical Care Renal Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687594
- Sponsor's protocol ID
- VFMCRP-MEAF-PA21-01-EU
- Acronym
- VERIFIE
- Status last verified
- Sep 2019
- First submitted
- 9 Feb 2016
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis or Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT02687594
- Acronym / sponsor ID
- VERIFIE / VFMCRP-MEAF-PA21-01-EU
- Conditions
- Hyperphosphatemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Vifor Fresenius Medical Care Renal PharmaIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2016 (actual)
- Primary completion
- 6 Apr 2019 (actual)
- Study completion
- 6 Apr 2019 (actual)
- First posted
- 22 Feb 2016 (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.
An oral highly potent P binder Velphoro is a mixture of polynuclear iron(III) oxyhydroxide, sucrose, and starches. It was well tolerated in the clinical development program. The approved indication in the European Union (EU) is to control serums phosphorus (sP) levels in adult CKD (Chronic kidney disease) patients on HD (Haemodialysis) or PD (Peritoneal dialysis).
It is of major interest to observe the drug in daily use outside of controlled trial settings. The Marketing Authorisation Holder wishes to obtain further systematic data within a non-interventional study to investigate short and long-term safety.
Effectiveness and Treatment adherence during real-life use will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group | – | Drug: sucroferric oxyhydroxidesucroferric oxyhydroxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients with a diagnosis of hyperphosphataemia who are due to be treated with Velphoro according to the product's Summary of Product Characteristics (SmPC) are eligible for this non-interventional study.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Signed informed consent
- Indication for Velphoro treatment in accordance with the SmPC
- Prevalent dialysis patients with a dialysis vintage of at least 6 months (HD or PD)
- Treatment-naïve or pre-treated with anti-hyperphosphataemic therapy
Key exclusion criteria (3 listed)
- Prior participation in this NIS (Non-Interventional Study)
- Parallel participation in an interventional study
- Enrolment in a prior clinical trial with Velphoro
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 |
|---|---|---|
| sucroferric oxyhydroxideAlso: PA21 (Velphoro)The non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by a sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour. | Drug | single group |
Primary outcome
Incidence of Adverse Drug Reactions (ADRs)
Time frame: through study completion, up to 42 months
Proportion of Adverse Drug Reactions (ADRs)
Time frame: through study completion, up to 42 months
3 secondary outcomes
Patient Reported Outcome questionnaire - Adherence to Velphoro based on the standard Morisky questionnaire
Time frame: through study completion, up to 42 months
Patient Reported Outcome questionnaire - Perceived Pill based on the ACTG questionnaire
Time frame: through study completion, up to 42 months
Patient Reported Outcome questionnaire - Treatment satisfaction based on the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time frame: through study completion, up to 42 months
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 1 Oct 2019.
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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.
Sebastian Walpen, Dr. study chair
Vifor Fresenius Medical Care Renal Pharma
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperphosphatemia, run by Vifor Fresenius Medical Care Renal Pharma at 7 sites in 7 countries.
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 5 inclusion and 3 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Germany, Greece, Italy, Netherlands and 2 more countries. 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.
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?
Incidence of Adverse Drug Reactions (ADRs) (time frame: through study completion, up to 42 months). The study lists 2 primary outcomes in all. 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 1 Oct 2019.