Chronic Kidney DiseasesPhase 4COMPASSNCT03236246
KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)
A Phase 4 study testing KRX-0502 in people with Chronic Kidney Diseases and Iron Deficiency Anemia, run by Keryx Biopharmaceuticals at 28 sites in United States.
Trial summary
The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Iron Deficiency Anemia
- 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
- 206 participants
- Where
- 28 sitesUnited States
- Study dates
- 15 Aug 2017to 27 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min
- Hgb ≥8.5 g/dL and ≤11.5 g/dL
- Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%
- Serum intact parathyroid hormone ≤600 pg/mL
Who cannot join
- Serum phosphate <3.0 mg/dL
- Intravenous (IV) iron administered within 4 weeks prior to Screening
- Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening
- Blood transfusion within 4 weeks prior to Screening
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, 28801
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, 30904
Research Management, Inc.
Austin, Texas, 78751
Research Management, Inc.
Austin, Texas, 78758
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28207
Research by Design, LLC
Chicago, Illinois, 60643
California Institute of Renal Research
Chula Vista, California, 91910
Columbia Nephrology Associates, PA
Columbia, South Carolina, 29203
Renal Associates, LLC
Columbus, Georgia, 31904
Denver Nephrologists, P.C.
Denver, Colorado, 80230
Hypertension and Nephrology Association
Eatontown, New Jersey, 07724
California Institute of Renal Research
El Centro, California, 92243
Division of Kidney/HTN Research
Great Neck, New York, 11021
Eastern Nephrology Associates
Greenville, North Carolina, 27834
South Mississippi Medical Research, LLC
Gulfport, Mississippi, 39501
Southeastern Nephrology Associates
Jacksonville, North Carolina, 28546
Clinical Research Consultants
Kansas City, Missouri, 64111
P & I Clinical Research, LLC
Lufkin, Texas, 75904
Miami Kidney Group
Miami, Florida, 33143
Kidney and Hypertension Specialists of Miami, P.A.
Miami, Florida, 33150
Nephrology Associates, P.C.
Nashville, Tennessee, 37205
Eastern Nephrology Associates
New Bern, North Carolina, 28562
South Carolina Nephrology & Hypertension Center, Inc
Orangeburg, South Carolina, 29118
Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
Phoenix, Arizona, 85032
California Institute of Renal Research
Poway, California, 92064
Sierra Nevada Nephrology Consultants
Reno, Nevada, 89511
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212
Southeastern Nephrology
Wilmington, North Carolina, 28401
About this study
Official title: Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia
The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney disease (CKD).
Read the detailed description
This is a Phase 4, 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods: a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as needed.
- Conditions
- Chronic Kidney Diseases, Iron Deficiency Anemia
- Being tested
- KRX-0502
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia, Iron-Deficiency
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
Oral ferric citrate with meals
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | KRX-0502 1 tablet thrice daily (TID) with meals Receives: Drug: KRX-0502 |
| Group 2 | Experimental | KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals Receives: Drug: KRX-0502 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin (Hgb) at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; Week 24
Secondary outcomes (27)
Change From Baseline in Hgb at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; Week 48
Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period
The Kaplan-Meier estimator of the survival function of time from randomization to the first increase from Baseline Hgb of at least 0.5 g/dL for each of the two starting dose treatment groups were obtained.
Measured: from Randomization to Week 24
Change From Baseline in Transferrin Saturation (TSAT) at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; Week 24
Change From Baseline in TSAT at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; Week 48
Change From Baseline in Ferritin at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; Week 24
Change From Baseline in Ferritin at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; Week 48
Change From Baseline in Serum Phosphate at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; up to Week 24
Change From Baseline in Serum Phosphate at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; Week 48
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; Week 24
Change From Baseline in eGFR at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; Week 48
Change From Baseline in Bicarbonate at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; Week 24
Change From Baseline in Bicarbonate at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Measured: Baseline; Week 48
Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope analysis of covariance (ANCOVA) model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.
Measured: Baseline; Week 24
Change From Baseline in iPTH at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Measured: Baseline; Week 48
Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Measured: Baseline; Week 24
Change From Baseline in C-terminal FGF23 at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Measured: Baseline; Week 48
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.
Measured: Baseline; Week 24
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Measured: Baseline; Week 48
Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Measured: Baseline; Week 24
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Measured: Baseline; Week 48
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Measured: Baseline; Week 24
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Measured: Baseline; Week 48
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.
Measured: Baseline; Week 24
Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.
Measured: Baseline; Week 48
Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period
A hospitalization is defined as admission to the hospital.
Measured: up to Week 48
Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period
A hospitalization is defined as admission to the hospital.
Measured: up to Week 48
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period
Treatment-emergent adverse events are defined as adverse events that began after the first administration of study medication or pre-existing conditions that worsened after the first dose of study medication.
Measured: up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start15 Aug 2017
- Primary completion30 Aug 2019
- Study completion27 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 Chronic Kidney DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keryx Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Keryx Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236246
- Sponsor's protocol ID
- KRX-0502-402
- Acronym
- COMPASS
- Status last verified
- Mar 2021
- First submitted
- 26 Jul 2017
- Last updated
- 12 Mar 2021
- 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 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia
- ClinicalTrials.gov ID
- NCT03236246
- Acronym / sponsor ID
- COMPASS / KRX-0502-402
- Conditions
- Chronic Kidney Diseases, Iron Deficiency Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Keryx BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Posted 12 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney disease (CKD).
Detailed description
This is a Phase 4, 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods: a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: KRX-0502KRX-0502 1 tablet thrice daily (TID) with meals |
| Group 2 | Experimental | Drug: KRX-0502KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min
- Hgb ≥8.5 g/dL and ≤11.5 g/dL
- Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%
- Serum intact parathyroid hormone ≤600 pg/mL
Key exclusion criteria (4 listed)
- Serum phosphate <3.0 mg/dL
- Intravenous (IV) iron administered within 4 weeks prior to Screening
- Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening
- Blood transfusion within 4 weeks prior to Screening
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 citrateOral ferric citrate with meals | Drug | Group 1, Group 2 |
Primary outcome
Change From Baseline in Hemoglobin (Hgb) at Week 24
Time frame: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
27 secondary outcomes
Change From Baseline in Hgb at Week 48
Time frame: Baseline; Week 48
Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period
Time frame: from Randomization to Week 24
Change From Baseline in Transferrin Saturation (TSAT) at Week 24
Time frame: Baseline; Week 24
Change From Baseline in TSAT at Week 48
Time frame: Baseline; Week 48
Change From Baseline in Ferritin at Week 24
Time frame: Baseline; Week 24
Change From Baseline in Ferritin at Week 48
Time frame: Baseline; Week 48
Change From Baseline in Serum Phosphate at Week 24
Time frame: Baseline; up to Week 24
Change From Baseline in Serum Phosphate at Week 48
Time frame: Baseline; Week 48
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Time frame: Baseline; Week 24
Change From Baseline in eGFR at Week 48
Time frame: Baseline; Week 48
Change From Baseline in Bicarbonate at Week 24
Time frame: Baseline; Week 24
Change From Baseline in Bicarbonate at Week 48
Time frame: Baseline; Week 48
Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24
Time frame: Baseline; Week 24
Change From Baseline in iPTH at Week 48
Time frame: Baseline; Week 48
Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24
Time frame: Baseline; Week 24
Change From Baseline in C-terminal FGF23 at Week 48
Time frame: Baseline; Week 48
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24
Time frame: Baseline; Week 24
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48
Time frame: Baseline; Week 48
Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures
Time frame: Baseline; Week 24
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures
Time frame: Baseline; Week 48
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment
Time frame: Baseline; Week 24
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment
Time frame: Baseline; Week 48
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24
Time frame: Baseline; Week 24
Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48
Time frame: Baseline; Week 48
Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period
Time frame: up to Week 48
Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period
Time frame: up to Week 48
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period
Time frame: up to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- 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.
Medical Director study director
Keryx Biopharmaceuticals
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing KRX-0502 in people with Chronic Kidney Diseases and Iron Deficiency Anemia, run by Keryx Biopharmaceuticals at 28 sites 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 4 inclusion and 4 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 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites 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 12 Mar 2021). 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 From Baseline in Hemoglobin (Hgb) at Week 24 (time frame: Baseline; Week 24). 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 12 Mar 2021.