HyperphosphatemiaNCT00967993
Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
An observational study of Hyperphosphatemia and End-stage Renal Disease, run by Keryx Biopharmaceuticals at 3 sites in Israel.
Trial summary
The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia, End-stage Renal Disease, Renal Failure Chronic Requiring Hemodialysis
- What is being tested?
- ferric citrate
- Type of treatment
- Pill or oral medicine
- How many people
- 22 participants
- Where
- 3 sitesIsrael
- Study dates
- Jan 2010to May 2010
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients selected from pool of dialysis patients at each clinic.
Who may be able to join
- Males and non-pregnant, non-lactating females
- Age > 18 years
- On thrice weekly hemodialysis for at least the previous three months prior to screening
- Serum phosphorus levels ≥ 2.5 mg/dL and < 8.5 mg/dL at Screening Visit (Visit 0)
- Serum phosphorus levels > 5.5 mg/dL at Study Drug Initiation Visit (Visit 3)
- Taking 3 to 18 tablets/capsules/day of calcium acetate calcium carbonate, lanthanum carbonate, sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at screening
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- Serum ferritin <1000micrograms/L and Transferrin Saturation (TSAT) <50%
- Willing to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate)
- Willing and able to give informed consent
Who cannot join
- Parathyroidectomy within six months prior to Screening Visit (Visit 0)
- Actively symptomatic gastrointestinal bleeding and inflammatory bowel disease
- Serum phosphorus levels >10.0 mg/dL documented in the three monthly laboratories (done routinely in the dialysis unit) in the three months prior to the Screening Visit (Visit 0)
- History of multiple drug allergies
- History of malignancy in the last five years (treated cervical or skin cancer may be permitted if approved by Keryx)
- Previous intolerance to oral ferric citrate
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- Absolute requirement for oral iron therapy
- Absolute requirement for Vitamin C (multivitamins [Centrum, Nephrocaps, 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
- Prior exposure to ferric citrate
- Patients with hemochromatosis or Thalassemia
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Barzilai Medical Center Ben-Gurion University
Ashkelon, 78306
Hadassah University Hospital-Ein Kerem
Jerusalem, 91120
Assaf Haraofeh Medical Center
Tsrifin, 70300
About this study
Official title: A 6-Week Feasibility Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD).
Read the detailed description
This is a multi-center, non-blinded, efficacy and tolerability trial in patients with ESRD on dialysis three times per week. Approximately 24 patients (approximately twelve diabetic patients and approximately twelve non-diabetic patients) in Israel will be initiated on KRX-0502 (ferric citrate). The study will consist of a two-week washout period immediately followed by a six-week treatment period in. Patients will be initiated on study drug over two to three weeks.
- Being tested
- ferric citrate
- Keywords
- hyperphosphatemia, end-stage renal disease, ESRD, hemodialysis, diabetes, dialysis
- Medical subject headings
- Hyperphosphatemia, Kidney Failure, Chronic, Diabetes Mellitus
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
KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate
| Study group | Role | What they receive |
|---|---|---|
| KRX-0502 (ferric citrate) | KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate. All patients initiated on study drug will start with a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day.
Patients will be titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels go below normal, there will be a decrease in pills; if serum phosphorus levels go above normal, there wil be an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day will be 12, or 12 g/day of ferric citrate.
Patients will take study drug orally with meals or snacks or within one hour after their meals or snacks. Receives: Drug: ferric citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period.
Measured: 4 weeks
Secondary outcomes (1)
The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
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 (2)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keryx Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Itamar Raz, MD, Principal investigator, Hadassah University Hospital-Ein Kerem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967993
- Sponsor's protocol ID
- KRX-0502-202
- Status last verified
- Nov 2014
- First submitted
- 27 Aug 2009
- Last updated
- 5 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hsu CH, Patel SR, Young EW. New phosphate binding agents: ferric compounds. J Am Soc Nephrol. 1999 Jun;10(6):1274-80. doi: 10.1681/ASN.V1061274.
PubMed 10361865Yang WC, Yang CS, Hou CC, Wu TH, Young EW, Hsu CH. An open-label, crossover study of a new phosphate-binding agent in haemodialysis patients: ferric citrate. Nephrol Dial Transplant. 2002 Feb;17(2):265-70. doi: 10.1093/ndt/17.2.265.
PubMed 11812877
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week Feasibility Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
- ClinicalTrials.gov ID
- NCT00967993
- Acronym / sponsor ID
- KRX-0502-202
- Keywords
- hyperphosphatemia, end-stage renal disease, ESRD, hemodialysis, diabetes, dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Keryx BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Posted 18 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD).
Detailed description
This is a multi-center, non-blinded, efficacy and tolerability trial in patients with ESRD on dialysis three times per week. Approximately 24 patients (approximately twelve diabetic patients and approximately twelve non-diabetic patients) in Israel will be initiated on KRX-0502 (ferric citrate). The study will consist of a two-week washout period immediately followed by a six-week treatment period in. Patients will be initiated on study drug over two to three weeks.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KRX-0502 (ferric citrate) | – | Drug: ferric citrateKRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate. All patients initiated on study drug will start with a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day. Patients will be titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels go below normal, there will be a decrease in pills; if serum phosphorus levels go above normal, there wil be an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day will be 12, or 12 g/day of ferric citrate. Patients will take study drug orally with meals or snacks or within one hour after their meals or snacks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected from pool of dialysis patients at each clinic.
Key inclusion criteria (9 listed)
- Males and non-pregnant, non-lactating females
- Age > 18 years
- On thrice weekly hemodialysis for at least the previous three months prior to screening
- Serum phosphorus levels ≥ 2.5 mg/dL and < 8.5 mg/dL at Screening Visit (Visit 0)
- Serum phosphorus levels > 5.5 mg/dL at Study Drug Initiation Visit (Visit 3)
Key exclusion criteria (17 listed)
- Parathyroidectomy within six months prior to Screening Visit (Visit 0)
- Actively symptomatic gastrointestinal bleeding and inflammatory bowel disease
- Serum phosphorus levels >10.0 mg/dL documented in the three monthly laboratories (done routinely in the dialysis unit) in the three months prior to the Screening Visit (Visit 0)
- History of multiple drug allergies
- History of malignancy in the last five years (treated cervical or skin cancer may be permitted if approved by Keryx)
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-0502KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate | Drug | KRX-0502 (ferric citrate) |
Primary outcome
The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period.
Time frame: 4 weeks
1 secondary outcome
The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10361865Hsu CH, Patel SR, Young EW. New phosphate binding agents: ferric compounds. J Am Soc Nephrol. 1999 Jun;10(6):1274-80. doi: 10.1681/ASN.V1061274.
- Background: PubMed 11812877Yang WC, Yang CS, Hou CC, Wu TH, Young EW, Hsu CH. An open-label, crossover study of a new phosphate-binding agent in haemodialysis patients: ferric citrate. Nephrol Dial Transplant. 2002 Feb;17(2):265-70. doi: 10.1093/ndt/17.2.265.
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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.
Itamar Raz, MD principal investigator
Hadassah University Hospital-Ein Kerem
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperphosphatemia and End-stage Renal Disease, run by Keryx Biopharmaceuticals at 3 sites in Israel.
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 9 inclusion and 17 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 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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?
Yes. Results are posted in the registry (first posted 18 Nov 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 Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period. (time frame: 4 weeks). 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 NCT00967993, which also lists 2 linked publications.
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 5 Dec 2014.