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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:October 2014
End Date:January 2016

Use our guide to learn which trials are right for you!

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").

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

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
We found this trial at
36
sites
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Pembroke Pines, Florida 33028
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
77 Cadillac Drive
Sacramento, California 95825
916-929-8564
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Alexandria, Virginia 22304
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Augusta, Georgia 30901
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Austin, Texas 78751
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78751
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baton Rouge, Louisiana 70808
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Deland, Florida 32720
?
mi
from
Deland, FL
Click here to add this to my saved trials
Denver, Colorado 80230
?
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48236
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Edgewater, Florida 32132
?
mi
from
Edgewater, FL
Click here to add this to my saved trials
Evergreen Park, Illinois 60805
?
mi
from
Evergreen Park, IL
Click here to add this to my saved trials
Glendale, California 91204
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Hampton, Virginia 23666
?
mi
from
Hampton, VA
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
La Palma, California 90623
?
mi
from
La Palma, CA
Click here to add this to my saved trials
Lincoln, Nebraska 68105
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Los Angeles, California 90022
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Lufkin, Texas 75904
?
mi
from
Lufkin, TX
Click here to add this to my saved trials
Macon, Georgia 31217
?
mi
from
Macon, GA
Click here to add this to my saved trials
Meridian, Idaho 83642
?
mi
from
Meridian, ID
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pontiac, Michigan 48341
?
mi
from
Pontiac, MI
Click here to add this to my saved trials
?
mi
from
Reno, NV
Click here to add this to my saved trials
Riverside, California
?
mi
from
Riverside, CA
Click here to add this to my saved trials
San Antonio, Texas 78215
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92154
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Tempe, Arizona 85284
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials