Anemia of Chronic Kidney DiseasePhase 2NCT02128074
A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia
A Phase 2 study testing KRX-0502 in people with Anemia of Chronic Kidney Disease, run by Keryx Biopharmaceuticals at 3 sites in Israel.
Trial summary
The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- KRX-0502
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesIsrael
- Study dates
- Apr 2014to Nov 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and non-lactating females with negative serum pregnancy test (for females of child-bearing potential) at Screening
- Age ≥ 18 years
- Serum ferritin ≤ 300 ng/mL and TSAT ≤ 25% at Screening
- Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL at Screening
- eGFR <60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation
Who cannot join
- Subjects receiving phosphate binder medication(s) at, or within 4 weeks prior to, screening
- Symptomatic gastrointestinal bleeding, inflammatory bowel disease, inflammatory bowel syndrome and/or Crohn's Disease within 24 weeks prior to \ Screening
- Evidence of acute kidney injury or requirement for dialysis within 8 weeks prior to Screening
- Kidney transplant anticipated or start of dialysis expected within 16 weeks of Screening
- History of hemochromatosis
- IV iron administered within 4 weeks prior to Screening
Show all 17Show fewer
- Erythropoiesis-Stimulating Agent (ESA) administered within 4 weeks prior to Screening
- Blood transfusion within 4 weeks prior to Screening
- Receipt of any investigational drug within 4 weeks prior to Screening
- Cause of anemia other than iron deficiency or chronic kidney disease
- History of malignancy in the last five years
- Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12 months prior to Screening
- Any known allergies to iron products
- Previous intolerance to oral ferric citrate
- Psychiatric disorder that interferes with the subject's ability to comply with the study protocol
- Planned surgery or hospitalization during the trial
- Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Barzilai Medical Center
Ashkelon
Western Galilee Hospital
Nahariya
Nazareth Hospital- EMMS
Nazareth
About this study
Official title: A Phase 2 Pilot Study of KRX-0502 (Ferric Citrate) in Treating Iron-deficiency Anemia in Patients With Stage 3-5 Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD)
The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).
Read the detailed description
Previous clinical trials have tested KRX-0502 administered with food, in dialysis-dependent and NDD-CKD patients.
This clinical trial will evaluate the safety and efficacy of KRX-0502 in treating iron deficiency anemia in anemic, stage III to V NDD-CKD patients in a new dosing regimen (without food).
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- KRX-0502
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRX-0502Drug
Also called ferric citrate
1g tablets of KRX-0502
| Study group | Role | What they receive |
|---|---|---|
| KRX-0502 | Experimental | KRX-0502 (ferric citrate) Receives: Drug: KRX-0502 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin From Baseline to the End of 8-week Treatment Period
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionNov 2014
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 Anemia of Chronic Kidney DiseaseStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keryx Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoram Yagil, MD, Study chair, The Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128074
- Sponsor's protocol ID
- KRX-0502-207
- Status last verified
- Nov 2017
- First submitted
- 28 Apr 2014
- Last updated
- 24 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Pilot Study of KRX-0502 (Ferric Citrate) in Treating Iron-deficiency Anemia in Patients With Stage 3-5 Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD)
- ClinicalTrials.gov ID
- NCT02128074
- Acronym / sponsor ID
- KRX-0502-207
- Conditions
- Anemia of Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Keryx BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Posted 24 Aug 2018
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 the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).
Detailed description
Previous clinical trials have tested KRX-0502 administered with food, in dialysis-dependent and NDD-CKD patients.
This clinical trial will evaluate the safety and efficacy of KRX-0502 in treating iron deficiency anemia in anemic, stage III to V NDD-CKD patients in a new dosing regimen (without food).
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 | Experimental | Drug: KRX-0502KRX-0502 (ferric citrate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and non-lactating females with negative serum pregnancy test (for females of child-bearing potential) at Screening
- Age ≥ 18 years
- Serum ferritin ≤ 300 ng/mL and TSAT ≤ 25% at Screening
- Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL at Screening
- eGFR <60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation
Key exclusion criteria (17 listed)
- Subjects receiving phosphate binder medication(s) at, or within 4 weeks prior to, screening
- Symptomatic gastrointestinal bleeding, inflammatory bowel disease, inflammatory bowel syndrome and/or Crohn's Disease within 24 weeks prior to \ Screening
- Evidence of acute kidney injury or requirement for dialysis within 8 weeks prior to Screening
- Kidney transplant anticipated or start of dialysis expected within 16 weeks of Screening
- History of hemochromatosis
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 |
|---|---|---|
| KRX-0502Also: ferric citrate1g tablets of KRX-0502 | Drug | KRX-0502 |
Primary outcome
Change in Hemoglobin From Baseline to the End of 8-week Treatment Period
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Anemia of Chronic Kidney Disease
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruitingPhase 1
Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
Chronic Kidney Disease, Anemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
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.
Yoram Yagil, MD study chair
The Barzilai Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KRX-0502 in people with Anemia of Chronic Kidney 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 5 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 24 Aug 2018. 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.
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 24 Aug 2018). 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?
Change in Hemoglobin From Baseline to the End of 8-week Treatment Period (time frame: 8 weeks). 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 24 Aug 2018.