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Anemia of Chronic Kidney DiseasePhase 3NCT02268994

KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD

A Phase 3 study testing ferric citrate in people with Anemia of Chronic Kidney Disease, run by Keryx Biopharmaceuticals at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period"). 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?
ferric citrate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
234 participants
Where
36 sitesUnited States
Study dates
Oct 2014to Jan 2016
Phase
Phase 3
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

  • Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening
  • Age ≥18 years
  • CKD with Estimated Glomerular Filtration Rate (eGFR) <60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation (with a limit of up to 20% of the target randomization of 230 subjects with eGFR <15 mL/min)
  • Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements (in the opinion of the investigator)
  • Hgb ≥ 9.0 g/dL and ≤11.5 g/dL at Screening
  • Serum ferritin ≤200 ng/mL and Transferrin Saturation (TSAT) ≤25% at Screening
Show all 9Show fewer
  • Serum Intact Parathyroid Hormone (iPTH) ≤600 pg/mL at Screening
  • Must consume a minimum of 2 meals per day
  • Willing and able to give written informed consent

Who cannot join

  • Serum phosphate <3.5 mg/dL at Screening
  • Liver enzymes (ALT/AST) >X3 times upper limit of normal at Screening
  • Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to Screening
  • Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to Screening
  • Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of Screening
  • IV iron administered within 4 weeks prior to Screening
Show all 19Show 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
  • Malignancy (except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy)
  • History of hemochromatosis
  • Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the PI)
  • Subjects with known allergic reaction to previous oral iron therapy
  • 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 (anticipated to last >72 hours) during the randomized period of the trial other than dialysis access related surgery.
  • 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
  • Inability to cooperate with study personnel

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Mendez Center for Clinical Research

    Alexandria, Virginia, 22304

  • Mountain Kidney & Hypertension Associates

    Asheville, North Carolina, 28801

  • Kidney Care Associates, LLC

    Augusta, Georgia, 30909

  • Research Management, Inc

    Austin, Texas, 78732

  • Research Management, Inc.

    Austin, Texas, 78758

  • Renal Associates of Baton Rouge

    Baton Rouge, Louisiana, 70808

  • Metrolina Nephrology

    Charlotte, North Carolina, 28204

  • Creekside Medical Research

    DeLand, Florida, 32123

  • Denver Nephrology

    Denver, Colorado, 80230

  • Renaissance Renal Research

    Detroit, Michigan, 48236

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Advanced Renal Care

    Evergreen Park, Illinois, 60805

  • Nephrology Associates of Northern VA, Inc.

    Fairfax, Virginia, 22033

  • California Renal Research

    Glendale, California, 91204

  • Peninsula Kidney Associates

    Hampton, Virginia, 23666

  • Clinical Research Consultants

    Kansas City, Missouri, 64111

  • Southern California Medical Research Center

    La Palma, California, 90623

  • Lincoln Nephrology & Hypertension

    Lincoln, Nebraska, 68105

  • Academic Medical Research Institute, Inc

    Los Angeles, California, 90022

  • TAD Clinical Research

    Lufkin, Texas, 75904

  • Renal Physicians of Georgia, PC

    Macon, Georgia, 31217

  • Pacific Renal Research Institute

    Meridian, Idaho, 83642

  • Pines Clinical Research, Inc

    Pembroke Pines, Florida, 33028

  • AKDHC Medical Research Services, LLC

    Phoenix, Arizona, 85027

  • Michigan Kidney Consultants, PC

    Pontiac, Michigan, 48341

  • Sierra Nevada Nephrology Asoociates

    Reno, Nevada, 89519

  • Apex Research of Riverside

    Riverside, California, 92505

  • Capital Nephrology Medical Group

    Sacramento, California, 95825

  • Kidney & Hypertension Specialists

    San Antonio, Texas, 78207

  • Clinical Advancement Center

    San Antonio, Texas, 78215

  • San Antonio Kidney Disease Center

    San Antonio, Texas, 78229

  • La Jolla Clinical Research, Inc

    San Diego, California, 92103

  • California Institute of Renal Research

    San Diego, California, 92123

  • Western New England Renal & Transplant Associates

    Springfield, Massachusetts, 01107

  • Southwest Kidney Institute

    Tempe, Arizona, 85284

  • Kansas Nephrology Research Institute

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: A Phase 3 Study of KRX-0502 (Ferric Citrate) for the Treatment of Iron Deficiency Anemia (IDA) in Adult Subjects With Non-Dialysis Dependent (NDD) Chronic Kidney Disease

a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").

Read the detailed description

a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period"). The study will consist of 14 clinic visits over a period of 24 weeks. There will be a screening period of up to 14 days; Approximately 230 subjects will be randomized into the Randomized Period in a 1:1 ratio to receive either KRX-0502 or matching placebo, at baseline

Being tested
ferric citrate, Placebo
Keywords
ferric citrate, Chronic kidney disease, Anemia
Medical subject headings
Renal Insufficiency, Chronic, Anemia

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

    1 g ferric citrate containing approximately 210 mg of ferric iron

  • PlaceboDrug

    Matching placebo

Study groups in NCT02268994
Study groupRoleWhat they receive
KRX-0502 (ferric citrate)Experimental1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
Receives: Drug: ferric citrate
PlaceboPlacebo comparatorMatching Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period

    Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.

    Measured: Week 16

Secondary outcomes (5)

  1. Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline

    The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.

    Measured: Baseline and week 16

  2. Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline

    The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.

    Measured: Baseline and week 16

  3. Mean Change in Ferritin at the End of 16 Weeks Minus Baseline

    The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.

    Measured: Baseline and week 16

  4. Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)

    Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period

    Measured: Week 16

  5. Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline

    The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.

    Measured: Baseline and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02268994
Sponsor's protocol ID
KRX-0502-306
Status last verified
Feb 2018
First submitted
11 Oct 2014
Last updated
22 Mar 2018
Data monitoring committee
No

Publications

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PubMed 40576086

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ferric citrate in people with Anemia of Chronic Kidney Disease, run by Keryx Biopharmaceuticals at 36 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 9 inclusion and 19 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 Feb 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?

Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period (time frame: Week 16). 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 NCT02268994, which also lists 1 linked publication.

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 22 Mar 2018.

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