Adult | Age
Item
1. adult female or male subjects; age ≥18 years.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Kidney Failure, Chronic | Hemodialysis
Item
2. end stage renal disease subjects treated in-center with the modality of hemodialysis for ≥120 days.
boolean
C0022661 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
Anemia
Item
3. diagnosed with anemia.
boolean
C0002871 (UMLS CUI [1])
Epogen Intravenous | Anemia | Unit dose Algorithm Erythropoiesis Stimulating Agents
Item
4. administered routine epogen therapy for at least 16 weeks by an iv route for treatment of anemia using the epogen version of the fresenius medical care north america (fmcna) dosing algorithm for esa.
boolean
C0700704 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0002871 (UMLS CUI [2])
C0869039 (UMLS CUI [3,1])
C0002045 (UMLS CUI [3,2])
C1959590 (UMLS CUI [3,3])
Epogen Intravenous | Unit dose Algorithm Erythropoiesis Stimulating Agents | Anemia Management
Item
5. currently using the iv epogen version of the esa dosing algorithm cmab 5 for anemia management.
boolean
C0700704 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0869039 (UMLS CUI [2,1])
C0002045 (UMLS CUI [2,2])
C1959590 (UMLS CUI [2,3])
C0002871 (UMLS CUI [3,1])
C0376636 (UMLS CUI [3,2])
Hemodialysis | Iron replacement Intravenous | Unit dose Algorithm
Item
6. receiving hemodialysis at a clinic using the fmcna dosing algorithm for iv iron that is the fmcna standard of care for iron replacement.
boolean
C0019004 (UMLS CUI [1])
C0919650 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0869039 (UMLS CUI [3,1])
C0002045 (UMLS CUI [3,2])
Informed Consent Unable
Item
1. subjects unable to provide a signed and dated informed consent for this clinical research study.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Unwilling
Item
2. as determined by the investigator, female subjects of childbearing potential who do not agree to use a highly effective method of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Condition Study Subject Participation Status At risk | Condition Excludes Protocol Compliance
Item
3. any condition as determined by the investigator that would place a subject at an increased risk, or preclude subject's full compliance with the study procedures and visits.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
4. female subjects who are known to be or found to be, pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Inappropriate Erythropoiesis Stimulating Agents | Epogen Package Inserts | Other Coding | Recombinant Erythropoietin Antibodies Positive
Item
5. subjects that are not a candidate for esa therapies per the label warnings listed in the package insert for epogen and/or contraindications to epoetin hospira listed in the investigators' brochure; or have had a known positive test for anti-rhepo antibodies.
boolean
C0681850 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1959590 (UMLS CUI [1,3])
C0700704 (UMLS CUI [2,1])
C0030174 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
C0376541 (UMLS CUI [4,1])
C0003241 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
Investigational New Drugs
Item
6. treatment with any investigational drug within 30 days prior to randomization and throughout this clinical trial.
boolean
C0013230 (UMLS CUI [1])
Condition Resulting in Blood Loss | Menorrhagia | Peptic Ulcer | Gastrointestinal Hemorrhage | Hematological Disease | Hemoglobinopathy | Anticoagulation Therapy | Exception Dialysis | Exception Aspirin therapy
Item
7. diagnosed with any concurrent condition that could lead to greater-than-normal loss of blood, including but not limited to menorrhagia, peptic ulcer disease, gastrointestinal bleeding, blood dyscrasia, hemoglobinopathy, anticoagulation therapy (except when administered for the purpose of dialysis therapy and except aspirin (acetylsalicylic acid [asa] therapies)) etc.
boolean
C0348080 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C3163616 (UMLS CUI [1,3])
C0025323 (UMLS CUI [2])
C0030920 (UMLS CUI [3])
C0017181 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0019045 (UMLS CUI [6])
C0003281 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0011946 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C4303556 (UMLS CUI [9,2])
Blood Transfusion Quantity | Blood Donation Amount | Blood Loss Amount | Plasmapheresis
Item
8. history of transfusion of any blood product in the past 3 months, or 2 or more transfusions in the past 1 year; or donated or lost >475 ml blood volume (including plasmapheresis) in the past 3 months.
boolean
C0005841 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C3163616 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0032134 (UMLS CUI [4])
Erythropoiesis Stimulating Agents Active Long-term
Item
9. subjects currently receiving a long acting esa, or who have received a long acting esa in the 16 weeks prior to study randomization.
boolean
C1959590 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])