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

Phase 3

Completed

Conditions: Anemia of Chronic Kidney Disease

Interventions: Drug: Placebo
Drug: ferric citrate

Registration Number: NCT02268994

Lead Sponsor: Keryx Biopharmaceuticals

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 234

Inclusion Criteria

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
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

Exclusion Criteria

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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching Placebo
KRX-0502 (ferric citrate)	ferric citrate	1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron

Primary Outcome Measures

Name	Time	Method
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	Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline	Baseline and week 16	The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.
Mean Change in Ferritin at the End of 16 Weeks Minus Baseline	Baseline and week 16	The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.
Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline	Baseline and week 16	The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.
Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline	Baseline and week 16	The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.
Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)	Week 16	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

Trial Locations

Locations (36): California Renal Research
🇺🇸
Glendale, California, United States
Academic Medical Research Institute, Inc
🇺🇸
Los Angeles, California, United States
Kidney Care Associates, LLC
🇺🇸
Augusta, Georgia, United States
Advanced Renal Care
🇺🇸
Evergreen Park, Illinois, United States
Renal Physicians of Georgia, PC
🇺🇸
Macon, Georgia, United States
Mountain Kidney & Hypertension Associates
🇺🇸
Asheville, North Carolina, United States
Metrolina Nephrology
🇺🇸
Charlotte, North Carolina, United States
TAD Clinical Research
🇺🇸
Lufkin, Texas, United States
California Institute of Renal Research
🇺🇸
San Diego, California, United States
Southwest Kidney Institute
🇺🇸
Tempe, Arizona, 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
Pacific Renal Research Institute
🇺🇸
Meridian, Idaho, United States
Renal Associates of Baton Rouge
🇺🇸
Baton Rouge, Louisiana, United States
Western New England Renal & Transplant Associates
🇺🇸
Springfield, Massachusetts, United States
Lincoln Nephrology & Hypertension
🇺🇸
Lincoln, Nebraska, United States
Michigan Kidney Consultants, PC
🇺🇸
Pontiac, Michigan, United States
Sierra Nevada Nephrology Asoociates
🇺🇸
Reno, Nevada, United States
Apex Research of Riverside
🇺🇸
Riverside, California, United States
La Jolla Clinical Research, Inc
🇺🇸
San Diego, California, United States
Research Management, Inc
🇺🇸
Austin, Texas, United States
Research Management, Inc.
🇺🇸
Austin, Texas, United States
Mendez Center for Clinical Research
🇺🇸
Alexandria, Virginia, United States
Nephrology Associates of Northern VA, Inc.
🇺🇸
Fairfax, Virginia, United States
Kansas Nephrology Research Institute
🇺🇸
Wichita, Kansas, United States
AKDHC Medical Research Services, LLC
🇺🇸
Phoenix, Arizona, United States
Southern California Medical Research Center
🇺🇸
La Palma, California, United States
Denver Nephrology
🇺🇸
Denver, Colorado, United States
Capital Nephrology Medical Group
🇺🇸
Sacramento, California, United States
Renaissance Renal Research
🇺🇸
Detroit, Michigan, United States
San Antonio Kidney Disease Center
🇺🇸
San Antonio, Texas, United States
Kidney & Hypertension Specialists
🇺🇸
San Antonio, Texas, United States
Clinical Advancement Center
🇺🇸
San Antonio, Texas, United States
Clinical Research Consultants
🇺🇸
Kansas City, Missouri, United States
Peninsula Kidney Associates
🇺🇸
Hampton, Virginia, United States