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

NCT ID: NCT02268994

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-01-31

Brief 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").

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

Conditions

Anemia of Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

KRX-0502 (ferric citrate)

1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

Group Type: EXPERIMENTAL

ferric citrate

Intervention Type: DRUG

1 g ferric citrate containing approximately 210 mg of ferric iron

Placebo

Matching Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo

Interventions

ferric citrate

1 g ferric citrate containing approximately 210 mg of ferric iron

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

Other Intervention Names

KRX-0502

Eligibility Criteria

Inclusion Criteria

1. Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening

2. Age ≥18 years

3. 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)

4. Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements (in the opinion of the investigator)

5. Hgb ≥ 9.0 g/dL and ≤11.5 g/dL at Screening

6. Serum ferritin ≤200 ng/mL and Transferrin Saturation (TSAT) ≤25% at Screening

7. Serum Intact Parathyroid Hormone (iPTH) ≤600 pg/mL at Screening

8. Must consume a minimum of 2 meals per day

9. Willing and able to give written informed consent

Exclusion Criteria

1. Serum phosphate <3.5 mg/dL at Screening

2. Liver enzymes (ALT/AST) >X3 times upper limit of normal at Screening

3. Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to Screening

4. Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to Screening

5. Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of Screening

6. IV iron administered within 4 weeks prior to Screening

7. Erythropoiesis-stimulating agent (ESA) administered within 4 weeks prior to Screening

8. Blood transfusion within 4 weeks prior to Screening

9. Receipt of any investigational drug within 4 weeks prior to Screening

10. Cause of anemia other than iron deficiency or chronic kidney disease

11. Malignancy (except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy)

12. History of hemochromatosis

13. 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)

14. Subjects with known allergic reaction to previous oral iron therapy

15. Previous intolerance to oral ferric citrate

16. Psychiatric disorder that interferes with the subject's ability to comply with the study protocol

17. Planned surgery or hospitalization (anticipated to last >72 hours) during the randomized period of the trial other than dialysis access related surgery.

18. 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

19. Inability to cooperate with study personnel

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keryx Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffrey Block, MD

Role: STUDY_CHAIR

Denver Nephrology

Glenn Chertow, MD

Role: STUDY_CHAIR

Division of Nephrology at Stanford University School of Medicine

Steven Fishbane, MD

Role: STUDY_CHAIR

Kidney Disease and Hypertension at North Shore University Hospital/Long Island Jewish Medical Center

Locations

AKDHC Medical Research Services, LLC

Phoenix, Arizona, United States

Southwest Kidney Institute

Tempe, Arizona, United States

California Renal Research

Glendale, California, United States

Southern California Medical Research Center

La Palma, California, United States

Academic Medical Research Institute, Inc

Los Angeles, California, United States

Apex Research of Riverside

Riverside, California, United States

Capital Nephrology Medical Group

Sacramento, California, United States

La Jolla Clinical Research, Inc

San Diego, California, United States

California Institute of Renal Research

San Diego, California, United States

Denver Nephrology

Denver, Colorado, United States

Creekside Medical Research

DeLand, Florida, United States

Riverside Clinical Research

Edgewater, Florida, United States

Pines Clinical Research, Inc

Pembroke Pines, Florida, United States

Kidney Care Associates, LLC

Augusta, Georgia, United States

Renal Physicians of Georgia, PC

Macon, Georgia, United States

Pacific Renal Research Institute

Meridian, Idaho, United States

Advanced Renal Care

Evergreen Park, Illinois, United States

Kansas Nephrology Research Institute

Wichita, Kansas, United States

Renal Associates of Baton Rouge

Baton Rouge, Louisiana, United States

Western New England Renal & Transplant Associates

Springfield, Massachusetts, United States

Renaissance Renal Research

Detroit, Michigan, United States

Michigan Kidney Consultants, PC

Pontiac, Michigan, United States

Clinical Research Consultants

Kansas City, Missouri, United States

Lincoln Nephrology & Hypertension

Lincoln, Nebraska, United States

Sierra Nevada Nephrology Asoociates

Reno, Nevada, United States

Mountain Kidney & Hypertension Associates

Asheville, North Carolina, United States

Metrolina Nephrology

Charlotte, North Carolina, United States

Research Management, Inc

Austin, Texas, United States

Research Management, Inc.

Austin, Texas, United States

TAD Clinical Research

Lufkin, Texas, United States

Kidney & Hypertension Specialists

San Antonio, Texas, United States

Clinical Advancement Center

San Antonio, Texas, United States

San Antonio Kidney Disease Center

San Antonio, Texas, United States

Mendez Center for Clinical Research

Alexandria, Virginia, United States

Nephrology Associates of Northern VA, Inc.

Fairfax, Virginia, United States

Peninsula Kidney Associates

Hampton, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40576086 (View on PubMed)

Other Identifiers

KRX-0502-306

Identifier Type: -

Identifier Source: org_study_id