HyperphosphatemiaPhase 2NCT00648167
A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
A Phase 2 study testing ferric citrate in people with Hyperphosphatemia and End-stage Renal Disease, run by Keryx Biopharmaceuticals at 1 site in United States.
Trial summary
This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hyperphosphatemia, End-stage Renal Disease
- 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
- Mar 2008to Jan 2009
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and non-pregnant, nonlactating females
- Age > 18 years
- On thrice weekly hemodialysis for at least the previous 3 months prior to randomization
- Phosphorous levels ≥3.5mg/dL at Screening Visit
- On at least 12 tablets/capsules/day of calcium acetate (667mg), calcium carbonate (500mg), lanthanum carbonate (500mg), sevelamer hydrochloride (800mg or two 400mg tablets), or any combination of these agents
- Serum ferritin <1000micrograms/L and Transferrin Saturation (TSAT) <50%
- Willing to be discontinued from current phosphate binder(s) and initiated on Zerenex
- Willing and able to give informed consent
Who cannot join
- Parathyroidectomy within 6 months prior to Screening
- Actively symptomatic GI disease such as peptic ulcer disease, gastro esophageal reflux, diverticulosis, irritable bowel syndrome (treated asymptomatic is permitted)
- History of documented inflammatory bowel disease or erosive esophagitis
- Serum Phosphorus levels >10.0 mg/dL documented in the 3 monthly laboratories (done routinely in the dialysis unit) in the 3 months prior to the Screening Visit
- History of multiple drug allergies
- History of malignancy in the last 5 years (treated cervical or skin cancer may be permitted if approved by CCC)
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- Previous intolerance to oral ferric citrate
- Absolute requirement for oral iron therapy
- Absolute requirement for Vitamin C (multivitamins [Neprocaps, Renaphro, etc.] allowed)
- Absolute requirement for calcium, magnesium, or aluminum containing drugs with meals
- Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
- Inability to tolerate oral drug intake
- Planned surgery or hospitalization during the study (scheduled outpatient access surgery allowed)
- Any other medical condition that renders the patient unable to or unlikely to complete the study or that would interfere with optimal participation in the study or produce significant risk to the patient
- Receipt of any investigational drug within 30 days of randomization
- Inability to cooperate with study personnel or history of noncompliance
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.
Read the detailed description
The purpose of this study is to evaluate the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease. These patients will be switched to Zerenex™ from their current high dose of phosphate binder and, based on their serum phosphorus levels, will be titrated up from 3.4g/day of Zerenex™ to maximum tolerated and safe doses of Zerenex™. Doses will be adjusted weekly, based on serum phosphorus levels, with the maximum dose administered being approximately 12g/day.
- Conditions
- Hyperphosphatemia, End-stage Renal Disease
- Being tested
- ferric citrate
- Keywords
- ESRD, end-stage renal disease, end stage renal disease, hemodialysis, dialysis, kidney failure, renal failure, kidney, renal, phosphate binder, phosphorus
- Medical subject headings
- Hyperphosphatemia, Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferric citrateDrug
Also called KRX-0502
ferric citrate will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study.
| Study group | Role | What they receive |
|---|---|---|
| KRX-0502 (ferric citrate) | Experimental | All patients will be switched from their current phosphate binder to Zerenex, and titrated to the maximum tolerated dose (up to about 12g/day) based on their serum phosphorus levels. Receives: Drug: ferric citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2009
- Study completionJan 2009
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keryx Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Collaborative Study Group (CSG)
- Responsible party
- Sponsor
- Investigators
- Julia B Lewis, MD, Study chair, Collaborative Study Group at the Nephrology Clinical Trials Center, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648167
- Sponsor's protocol ID
- KRX-0502-201
- Status last verified
- Mar 2017
- First submitted
- 27 Mar 2008
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
- ClinicalTrials.gov ID
- NCT00648167
- Acronym / sponsor ID
- KRX-0502-201
- Conditions
- Hyperphosphatemia, End-stage Renal Disease
- Keywords
- ESRD, end-stage renal disease, end stage renal disease, hemodialysis, dialysis, kidney failure, renal failure, kidney
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Keryx BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Collaborative Study Group (CSG)
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Posted 9 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.
Detailed description
The purpose of this study is to evaluate the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease. These patients will be switched to Zerenex™ from their current high dose of phosphate binder and, based on their serum phosphorus levels, will be titrated up from 3.4g/day of Zerenex™ to maximum tolerated and safe doses of Zerenex™. Doses will be adjusted weekly, based on serum phosphorus levels, with the maximum dose administered being approximately 12g/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KRX-0502 (ferric citrate) | Experimental | Drug: ferric citrateAll patients will be switched from their current phosphate binder to Zerenex, and titrated to the maximum tolerated dose (up to about 12g/day) based on their serum phosphorus levels. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and non-pregnant, nonlactating females
- Age > 18 years
- On thrice weekly hemodialysis for at least the previous 3 months prior to randomization
- Phosphorous levels ≥3.5mg/dL at Screening Visit
- On at least 12 tablets/capsules/day of calcium acetate (667mg), calcium carbonate (500mg), lanthanum carbonate (500mg), sevelamer hydrochloride (800mg or two 400mg tablets), or any combination of these agents
Key exclusion criteria (16 listed)
- Parathyroidectomy within 6 months prior to Screening
- Actively symptomatic GI disease such as peptic ulcer disease, gastro esophageal reflux, diverticulosis, irritable bowel syndrome (treated asymptomatic is permitted)
- History of documented inflammatory bowel disease or erosive esophagitis
- Serum Phosphorus levels >10.0 mg/dL documented in the 3 monthly laboratories (done routinely in the dialysis unit) in the 3 months prior to the Screening Visit
- History of multiple drug allergies
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: KRX-0502ferric citrate will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study. | Drug | KRX-0502 (ferric citrate) |
Primary outcome
The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- 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.
Julia B Lewis, MD study chair
Collaborative Study Group at the Nephrology Clinical Trials Center, Vanderbilt University Medical Center
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 ferric citrate in people with Hyperphosphatemia and End-stage Renal Disease, run by Keryx Biopharmaceuticals 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 8 inclusion and 16 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 4 Apr 2017. 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 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?
Yes. Results are posted in the registry (first posted 9 Oct 2014). 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?
The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28) (time frame: 28 days). 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 4 Apr 2017.