Clinical trial NCT02268994: KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia of Chronic Kidney Disease
Keywords: ferric citrate
Chronic kidney disease
Anemia
Lead sponsor: Keryx Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
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
timeFrame: Week 16
Secondary outcomes:
measure: Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline
timeFrame: Baseline and week 16
measure: Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline
timeFrame: Baseline and week 16
measure: Mean Change in Ferritin at the End of 16 Weeks Minus Baseline
timeFrame: Baseline and week 16
measure: Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)
timeFrame: Week 16
measure: Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline
timeFrame: Baseline and week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: AKDHC Medical Research Services, LLC
state: Arizona
city: Tempe
country: United States
facility: Southwest Kidney Institute
state: Arizona
city: Glendale
country: United States
facility: California Renal Research
state: California
city: La Palma
country: United States
facility: Southern California Medical Research Center
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute, Inc
state: California
city: Riverside
country: United States
facility: Apex Research of Riverside
state: California
city: Sacramento
country: United States
facility: Capital Nephrology Medical Group
state: California
city: San Diego
country: United States
facility: La Jolla Clinical Research, Inc
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: Denver
country: United States
facility: Denver Nephrology
state: Colorado
city: DeLand
country: United States
facility: Creekside Medical Research
state: Florida
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Clinical Research, Inc
state: Florida
city: Augusta
country: United States
facility: Kidney Care Associates, LLC
state: Georgia
city: Macon
country: United States
facility: Renal Physicians of Georgia, PC
state: Georgia
city: Meridian
country: United States
facility: Pacific Renal Research Institute
state: Idaho
city: Evergreen Park
country: United States
facility: Advanced Renal Care
state: Illinois
city: Wichita
country: United States
facility: Kansas Nephrology Research Institute
state: Kansas
city: Baton Rouge
country: United States
facility: Renal Associates of Baton Rouge
state: Louisiana
city: Springfield
country: United States
facility: Western New England Renal & Transplant Associates
state: Massachusetts
city: Detroit
country: United States
facility: Renaissance Renal Research
state: Michigan
city: Pontiac
country: United States
facility: Michigan Kidney Consultants, PC
state: Michigan
city: Kansas City
country: United States
facility: Clinical Research Consultants
state: Missouri
city: Lincoln
country: United States
facility: Lincoln Nephrology & Hypertension
state: Nebraska
city: Reno
country: United States
facility: Sierra Nevada Nephrology Asoociates
state: Nevada
city: Asheville
country: United States
facility: Mountain Kidney & Hypertension Associates
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Nephrology
state: North Carolina
city: Austin
country: United States
facility: Research Management, Inc
state: Texas
city: Austin
country: United States
facility: Research Management, Inc.
state: Texas
city: Lufkin
country: United States
facility: TAD Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Kidney & Hypertension Specialists
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney Disease Center
state: Texas
city: Alexandria
country: United States
facility: Mendez Center for Clinical Research
state: Virginia
city: Fairfax
country: United States
facility: Nephrology Associates of Northern VA, Inc.
state: Virginia
city: Hampton
country: United States
facility: Peninsula Kidney Associates
state: Virginia
Study officials:
affiliation: Denver Nephrology
name: Geoffrey Block, MD
role: STUDY_CHAIR
affiliation: Division of Nephrology at Stanford University School of Medicine
name: Glenn Chertow, MD
role: STUDY_CHAIR
affiliation: Kidney Disease and Hypertension at North Shore University Hospital/Long Island Jewish Medical Center
name: Steven Fishbane, MD
role: STUDY_CHAIR
References: