Peritoneal Dialysis ComplicationPhase 4NCT04046263

Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients

A Phase 4 study testing Sucroferric Oxyhydroxide Chewable Tablet in people with Peritoneal Dialysis Complication and Hyperphosphatemia, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prospective pilot study to determine if changing the phosphate binder to sucroferric oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in peritoneal dialysis patients. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Peritoneal Dialysis Complication, Hyperphosphatemia, Hypoalbuminemia
What is being tested?: Sucroferric Oxyhydroxide Chewable Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2020to 31 Jul 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years
On peritoneal dialysis at least 3 months with a Kt/V of ≥ 1.7
Use of Automated Peritoneal Dialysis
Serum phosphate > 5.5 mg/dL or <5.5 mg/dL on a binder other than velphoro
Serum albumin ≤ 3.7 g/dL
Able to provide consent
Ability to complete self-reported questionnaire

Who cannot join

Inadequate dialysis
Current use of sucroferric oxyhydroxide
Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 6 months
Active malignancy
Recent episode of peritonitis
Pregnancy or planning to become pregnant

Show all 9Show fewer

Anticipated kidney transplantation within 6 months
Factors judged to limit adherence to interventions
Known adverse side effect to sucroferric oxydroxide

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045

Other trials in United States

About this study

Conditions: Peritoneal Dialysis Complication, Hyperphosphatemia, Hypoalbuminemia
Being tested: Sucroferric Oxyhydroxide Chewable Tablet
Medical subject headings: Hyperphosphatemia, Hypoalbuminemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sucroferric Oxyhydroxide Chewable TabletDrug
Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal

Study groups in NCT04046263
Study group	Role	What they receive
Intervention	Experimental	Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal. Receives: Drug: Sucroferric Oxyhydroxide Chewable Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Phosphate at Baseline
Serum phosphate at baseline
Measured: Baseline
Serum Phosphate at 6 Months
Serum phosphate at end of study (6 months)
Measured: 6 months

Secondary outcomes (4)

Serum Albumin
Changes in serum albumin from baseline to 6 months
Measured: Baseline, 6 months
Serum FGF23
Change in serum FGF23 from baseline to 6 months
Measured: 6 months
Serum PTH
Change in serum PTH (perathyroid hormone) from baseline to 6 months
Measured: Baseline, 6 months
Serum Prealbumin
Change in prealbumin from baseline to 6 months
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202031 Jul 2021

First posted6 Aug 2019
Study start1 Feb 2020
Primary completion31 Jul 2021
Study completion31 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Peritoneal Dialysis ComplicationStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04046263
Sponsor's protocol ID: 19-1027
Status last verified: Aug 2022
First submitted: 2 Aug 2019
Last updated: 31 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: At the end of the study deidentified data will be available to other researchers

Publications

Perez L, You Z, Teitelbaum I, Andrews ES, Reddin R, Ramirez-Renteria L, Wilson G, Kendrick J. A 6-Month clinical practice pilot study of sucroferric oxyhydroxide on nutritional status in patients on peritoneal dialysis. BMC Nephrol. 2022 Jul 9;23(1):245. doi: 10.1186/s12882-022-02878-5.
PubMed 35810296

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication

All Peritoneal Dialysis Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
ClinicalTrials.gov ID: NCT04046263
Acronym / sponsor ID: 19-1027
Conditions: Peritoneal Dialysis Complication, Hyperphosphatemia, Hypoalbuminemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: 1 Feb 2020 (actual)
Primary completion: 31 Jul 2021 (actual)
Study completion: 31 Jul 2021 (actual)
First posted: 6 Aug 2019 (actual)
Results: Posted 31 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention	Experimental	Drug: Sucroferric Oxyhydroxide Chewable TabletOpen-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age ≥ 18 years
On peritoneal dialysis at least 3 months with a Kt/V of ≥ 1.7
Use of Automated Peritoneal Dialysis
Serum phosphate > 5.5 mg/dL or <5.5 mg/dL on a binder other than velphoro
Serum albumin ≤ 3.7 g/dL

Key exclusion criteria (9 listed)

Inadequate dialysis
Current use of sucroferric oxyhydroxide
Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 6 months
Active malignancy
Recent episode of peritonitis

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 Oxyhydroxide Chewable TabletPatients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal	Drug	Intervention

Primary outcome

Serum Phosphate at Baseline
Time frame: Baseline
Serum phosphate at baseline
Serum Phosphate at 6 Months
Time frame: 6 months
Serum phosphate at end of study (6 months)

4 secondary outcomes

Serum Albumin
Time frame: Baseline, 6 months
Serum FGF23
Time frame: 6 months
Serum PTH
Time frame: Baseline, 6 months
Serum Prealbumin
Time frame: 6 months

Results and safety

Results posted to the registry on 31 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sucroferric Oxyhydroxide	17	12

Primary outcome: Serum Phosphate at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: mg/dL

Measure	Intervention n = 17
Value	7.47 (1.76)

Primary outcome: Serum Phosphate at 6 Months

Time frame: 6 months. Mean (Standard Deviation). Unit: mg/dL

Measure	Intervention n = 12
Value	5.69 (1.17)

Population analysed: Outcome measure data could not be collected for all participants at the 6 month timepoint due to some participants discontinuing the study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	2 of 17 (11.8%)	9 of 17 (52.9%)	2 of 17

Limitations and caveats (from the sponsor): Study sample size is very small and there is no control group. This was due to complications that arose from the COVID-19 public health crisis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35810296Perez L, You Z, Teitelbaum I, Andrews ES, Reddin R, Ramirez-Renteria L, Wilson G, Kendrick J. A 6-Month clinical practice pilot study of sucroferric oxyhydroxide on nutritional status in patients on peritoneal dialysis. BMC Nephrol. 2022 Jul 9;23(1):245. doi: 10.1186/s12882-022-02878-5.
Individual participant dataSharing planned: Yes. At the end of the study deidentified data will be available to other researchers

Related trials for Peritoneal Dialysis Complication

Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication

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.

Jessica Kendrick, MD principal investigator

University of Colorado Denver | Anschutz

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 31 Aug 2022. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Serum Phosphate at Baseline (time frame: Baseline). 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?

On the ClinicalTrials.gov record for NCT04046263, which also lists 1 linked publication.

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 31 Aug 2022.