Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis



Status:Completed
Conditions:Iron Deficiency Anemia, Iron Deficiency Anemia, Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:10/22/2017
Start Date:November 2012
End Date:December 2013

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

A Phase 2 Study of KRX-0502 (Ferric Citrate) in Managing Serum Phosphorus and Iron Deficiency in Anemic Subjects With Stage III to V Chronic Kidney Disease Not on Dialysis

The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and
effective treatment for the management of serum phosphorus levels and iron deficiency in
anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of
treatment is approximately 12 weeks.

This is a randomized, double-blind, placebo-controlled, three-period, multi-center clinical
trial. Following a Screening and Qualification Period and a two-week Washout Period (for
those subjects entering the study on a phosphate binder), eligible subjects will be
randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or placebo for up to
approximately 12 weeks. The purpose of this study is to determine if KRX-0502 (ferric
citrate) is a safe and effective treatment for the management of serum phosphorus levels and
iron deficiency in anemic CKD subjects not on dialysis.

Inclusion Criteria:

- Stage III to V Chronic Kidney Disease

- Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization

- Ferritin 300 ng/mL or less

- Transferrin Saturation (TSAT) 30% or less

- Hemoglobin >9.0 and <12.0 g/dL

- Must consume a minimum of 2 meals per day

Exclusion Criteria:

- Parathyroidectomy within 24 weeks of study

- gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study

- Requirement for dialysis or kidney injury within 8 weeks of study

- Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating
Agent, blood transfusions, and Sensipar during the study

- Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals

- Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins

- History of hemochromatosis

- Allergy to iron products

- History of malignancy in last 5 years
We found this trial at
20
sites
841
mi
from
Detroit, MI
Click here to add this to my saved trials
858
mi
from
Asheville, NC
Click here to add this to my saved trials
1123
mi
from
Bethesda, MD
Click here to add this to my saved trials
409
mi
from
Denver, CO
Click here to add this to my saved trials
1145
mi
from
Edgewater, FL
Click here to add this to my saved trials
603
mi
from
Evergreen Park, IL
Click here to add this to my saved trials
1301
mi
from
Great Neck, NY
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
1133
mi
from
La Mesa, CA
Click here to add this to my saved trials
1050
mi
from
Meridian, ID
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1306
mi
from
Mineola, NY
Click here to add this to my saved trials
995
mi
from
Orangeburg, SC
Click here to add this to my saved trials
836
mi
from
Pontiac, MI
Click here to add this to my saved trials
1188
mi
from
Reno, NV
Click here to add this to my saved trials
1278
mi
from
Sacramento, CA
Click here to add this to my saved trials
583
mi
from
San Antonio, TX
Click here to add this to my saved trials
Springfield, Massachusetts 01199
1364
mi
from
Springfield, MA
Click here to add this to my saved trials
848
mi
from
Tempe, AZ
Click here to add this to my saved trials
Wilmington, North Carolina 28401
1135
mi
from
Wilmington, NC
Click here to add this to my saved trials