Adult | Age | Chronic haemodialysis Frequency Chronic Kidney Failure
Item
1. adult subject ≥ 18 years of age undergoing chronic hemodialysis for end-stage renal disease (esrd) three times a week
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1740835 (UMLS CUI [3,1])
C0439603 (UMLS CUI [3,2])
C0022661 (UMLS CUI [3,3])
Hemoglobin measurement Quantity
Item
2. hemoglobin (hgb) values on two successive screening/baseline measures immediately prior to the start of the study averaging 10.1 to 11.5 grams/ deciliter (g/dl), inclusive
boolean
C0518015 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Transferrin saturation measurement | Dialysis
Item
3. transferrin saturation (tsat) values that average 20% or more, but not exceeding 35%, prior to dialysis measured during the screening period
boolean
C1277709 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Ferritin measurement
Item
4. ferritin values that average 200 to 800 micrograms/ liter (µg/l), inclusive, measured during the screening period. an average ferritin above 800 µg/l but no greater than 1200 µg/l is allowed if the average tsat is 20% to no greater than 25%.
boolean
C0373607 (UMLS CUI [1])
Exception Vascular access operation | Hospitalization Absent Illness | Blood Transfusion Absent
Item
5. except for vascular access surgery, subject has no hospitalization in previous three months for a significant illness that, in the opinion of the investigator, confers a significant risk of hospitalization during the course of the study. no blood transfusions within the last 4 weeks are allowed.
boolean
C1705847 (UMLS CUI [1,1])
C1868857 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0221423 (UMLS CUI [2,3])
C0005841 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Dialyzer Blood Flow Rate Acceptable
Item
6. subject has an adequate dialyzer blood flow rate that is acceptable to the principal investigator
boolean
C0180409 (UMLS CUI [1,1])
C1999075 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
Hemoglobin measurement Quantity
Item
1. hemoglobin (hgb) values on two successive baseline/screening measurements that average ≥ 11.6g/dl
boolean
C0518015 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Malignant Neoplasm Involving Site | Exception Skin carcinoma
Item
2. subject with a current malignancy involving a site other than skin
boolean
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Substance Use Disorders
Item
3. subject with a history of drug or alcohol abuse within the last six months
boolean
C0038586 (UMLS CUI [1])
Completion of clinical trial Unable | Comorbidity | Life Expectancy
Item
4. subject believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year)
boolean
C2732579 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Study Subject Participation Status Risk Increased
Item
5. subject who the principal investigator considers will be placed at increased risk by the study procedures
boolean
C2348568 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,3])
Hemodialysis Regular Frequency Patient need for
Item
6. subject requiring hemodialysis more than 3 times per week on a regular basis.
boolean
C0019004 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0686904 (UMLS CUI [1,4])
Oral ron Discontinue Unable | Intravenous iron Discontinue Unable
Item
7. subject who is unable to discontinue oral iron or intravenous iron supplements for the duration of the study
boolean
C4518405 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3476073 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Pregnancy
Item
8. subject who is pregnant
boolean
C0032961 (UMLS CUI [1])
Informed Consent incompetent
Item
9. subject considered incompetent to give an informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0231190 (UMLS CUI [1,2])
Hepatitis B surface antigen positive
Item
10. subject with a positive test for hepatitis b surface antigen within the past 30 days or during screening
boolean
C0149709 (UMLS CUI [1])
HIV Infection
Item
11. subject with known hiv infection (if this is not known, no hiv testing will be performed)
boolean
C0019693 (UMLS CUI [1])
Liver Cirrhosis | Ascites | Esophageal Varices | Spider nevus | Hepatic Encephalopathy | Hepatitis C allowed | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
12. subject with cirrhosis of the liver based on histological criteria or clinical criteria (presence of ascites, esophageal varices, spider nevi, or history of hepatic encephalopathy). subject with hepatitis c, in the absence of cirrhosis, is not excluded from participation in the study if alt and ast levels are below 2 times the upper limit of normal consistently during the 2 months preceding enrollment
boolean
C0023890 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0014867 (UMLS CUI [3])
C0085666 (UMLS CUI [4])
C0019151 (UMLS CUI [5])
C0019196 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
C0201836 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
Tuberculosis | Mycoses | Virus Diseases | Parasitic infection
Item
13. subject with active tuberculosis, fungal, viral, or parasitic infection
boolean
C0041296 (UMLS CUI [1])
C0026946 (UMLS CUI [2])
C0042769 (UMLS CUI [3])
C0747256 (UMLS CUI [4])
Bacterial Infection Requirement Antibiotic therapy
Item
14. subject with active bacterial infection requiring antibiotic therapy
boolean
C0004623 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
QTc interval Pre-dialysis
Item
15. subject with pre-dialysis corrected q-wave to t-wave (qtc) interval ≥ 470 milliseconds (ms)
boolean
C0489625 (UMLS CUI [1,1])
C1264634 (UMLS CUI [1,2])
Hypokalemia | Decompensated cardiac failure | Family history of long QT syndrome At risk Torsades de points
Item
16. subject with a history of hypokalemia, decompensated heart failure, or family history of long qt syndrome that in the investigator's judgment poses a risk for torsades de pointe during the study
boolean
C0020621 (UMLS CUI [1])
C0581377 (UMLS CUI [2])
C3839836 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C3842160 (UMLS CUI [3,3])
Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Prolonged QTc interval
Item
17. subject using concomitant medications known to prolong qt/qtc interval (see appendix i, table a)
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C1560305 (UMLS CUI [2,3])
Erythropoietin U/week | Epogen | Procrit | Aranesp
Item
18. subject receiving more than 60,000 units or 120 micrograms of erythropoietin (epogen®, procrit®, or aranesp®) per week
boolean
C0014822 (UMLS CUI [1,1])
C0560588 (UMLS CUI [1,2])
C0700704 (UMLS CUI [2])
C0733467 (UMLS CUI [3])
C1134440 (UMLS CUI [4])
Study Subject Participation Status
Item
19. subject has participated in another clinical trial within 30 days of signing informed consent
boolean
C2348568 (UMLS CUI [1])