HyperphosphatemiaPhase 4NCT03079869
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
A Phase 4 study testing Ferric Citrate in people with Hyperphosphatemia, run by Kaiser Permanente at 1 site in United States.
Trial summary
Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Ferric Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 14 Sep 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate
- Mean serum phosphorus 4.0-<8.0 mg/dl for 6 months prior to enrollment
- No allergy to iron
- Mean corrected serum calcium > 8.0 mg/dl for 6 months prior to enrollment
- Mean PTH < 1000 pg/ml for 6 months prior to enrollment
- Mean ferritin < 1500 ng/ml and mean iron sat < 50% for 6 months prior to enrollment
Who cannot join
- History of gastrointestinal bleeding within past 6 months
- History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months
- Acute kidney injury equal to or less than 3 months before the initial screening date
- Active malignancy
- Functioning renal transplant
- Patients with iron overload syndrome (e.g., Hemochromatosis)
- History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease
- Active or past history of calciphylaxis
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
About this study
Official title: Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study From Kaiser Permanente Southern California
Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California
Read the detailed description
PROTOCOL SUMMARY
Title: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California
Short Title: FeCitrate
Protocol Number: KP FeCitrate
Study Phase: 4
Study Site(s): Los Angeles Kaiser Sunset Medical Center
Number of Subjects: 55
Study Arms: 1
Indication: Hyperphosphatemia in end stage renal disease
Primary Purpose: To evaluate the efficacy of ferric citrate for control of serum phosphorus levels and maintenance of adequate iron stores among dialysis-dependent patients before and after conversion from traditional phosphate binders in a "real world" environment
Overview of Study Design: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).
Investigational Product Administration: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
Study Endpoint: Mean serum phosphorus levels and rate of successful phosphorus control (<5.5mg/dl) 6 months before and after treatment with ferric citrate
Statistical Methods: Not powered to detect statistical significance
- Conditions
- Hyperphosphatemia
- Being tested
- Ferric Citrate
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric CitrateDrug
Also called Auryxia
One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
| Study group | Role | What they receive |
|---|---|---|
| Ferric Citrate | Other | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Receives: Drug: Ferric Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phosphorus Levels
Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use
Measured: 6 months
Secondary outcomes (3)
Intravenous (IV) Iron
The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.
Measured: 6 months
Erythropoiesis Stimulating Agents (ESA) Dose
Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome.
Measured: 6 months
Median Pill Count
median pill count of ferric citrate pills/day required to maintain phosphorus control
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start1 May 2017
- Primary completion14 Sep 2019
- Study completion14 Sep 2019
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.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Keryx Biopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Victoria Kumar, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079869
- Sponsor's protocol ID
- FeCitrate
- Other IDs
- 11035
- Status last verified
- Jan 2022
- First submitted
- 1 Mar 2017
- Last updated
- 13 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study From Kaiser Permanente Southern California
- ClinicalTrials.gov ID
- NCT03079869
- Acronym / sponsor ID
- FeCitrate
- Conditions
- Hyperphosphatemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Keryx Biopharmaceuticals
- Study start
- 1 May 2017 (actual)
- Primary completion
- 14 Sep 2019 (actual)
- Study completion
- 14 Sep 2019 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Posted 13 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California
Detailed description
PROTOCOL SUMMARY
Title: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California
Short Title: FeCitrate
Protocol Number: KP FeCitrate
Study Phase: 4
Study Site(s): Los Angeles Kaiser Sunset Medical Center
Number of Subjects: 55
Study Arms: 1
Indication: Hyperphosphatemia in end stage renal disease
Primary Purpose: To evaluate the efficacy of ferric citrate for control of serum phosphorus levels and maintenance of adequate iron stores among dialysis-dependent patients before and after conversion from traditional phosphate binders in a "real world" environment
Overview of Study Design: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).
Investigational Product Administration: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
Study Endpoint: Mean serum phosphorus levels and rate of successful phosphorus control (<5.5mg/dl) 6 months before and after treatment with ferric citrate
Statistical Methods: Not powered to detect statistical significance
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).
| Arm | Type | Receives |
|---|---|---|
| Ferric Citrate | Other | Drug: Ferric CitrateAuryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate
- Mean serum phosphorus 4.0-<8.0 mg/dl for 6 months prior to enrollment
- No allergy to iron
- Mean corrected serum calcium > 8.0 mg/dl for 6 months prior to enrollment
- Mean PTH < 1000 pg/ml for 6 months prior to enrollment
Key exclusion criteria (8 listed)
- History of gastrointestinal bleeding within past 6 months
- History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months
- Acute kidney injury equal to or less than 3 months before the initial screening date
- Active malignancy
- Functioning renal transplant
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 |
|---|---|---|
| Ferric CitrateAlso: AuryxiaOne to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. | Drug | Ferric Citrate |
Primary outcome
Phosphorus Levels
Time frame: 6 months
Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use
3 secondary outcomes
Intravenous (IV) Iron
Time frame: 6 months
Erythropoiesis Stimulating Agents (ESA) Dose
Time frame: 6 months
Median Pill Count
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Victoria Kumar, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Citrate in people with Hyperphosphatemia, run by Kaiser Permanente at 1 site in United States.
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 6 inclusion and 8 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 13 Jan 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 13 Jan 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?
Phosphorus Levels (time frame: 6 months). 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 13 Jan 2022.