0 Ratings
ID

44242

Description

Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT00548249

Link

https://clinicaltrials.gov/show/NCT00548249

Keywords

Versions (2)
  1. 12/6/17 12/6/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

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September 20, 2021

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License

Creative Commons BY 4.0
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    Eligibility Chronic Kidney Disease NCT00548249

    English

    Eligibility Chronic Kidney Disease NCT00548249

    1 forms  
    Criteria
    Description

    Criteria

    1. adult subject ≥ 18 years of age undergoing chronic hemodialysis for end-stage renal disease (esrd) three times a week
    Description

    Adult | Age | Chronic haemodialysis Frequency Chronic Kidney Failure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2]
    C0001779
    UMLS CUI [3,1]
    C1740835
    UMLS CUI [3,2]
    C0439603
    UMLS CUI [3,3]
    C0022661
    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
    Description

    Hemoglobin measurement Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0518015
    UMLS CUI [1,2]
    C1265611
    3. transferrin saturation (tsat) values that average 20% or more, but not exceeding 35%, prior to dialysis measured during the screening period
    Description

    Transferrin saturation measurement | Dialysis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1277709
    UMLS CUI [2]
    C0011946
    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%.
    Description

    Ferritin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0373607
    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.
    Description

    Exception Vascular access operation | Hospitalization Absent Illness | Blood Transfusion Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1705847
    UMLS CUI [1,2]
    C1868857
    UMLS CUI [2,1]
    C0019993
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [2,3]
    C0221423
    UMLS CUI [3,1]
    C0005841
    UMLS CUI [3,2]
    C0332197
    6. subject has an adequate dialyzer blood flow rate that is acceptable to the principal investigator
    Description

    Dialyzer Blood Flow Rate Acceptable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0180409
    UMLS CUI [1,2]
    C1999075
    UMLS CUI [1,3]
    C1879533
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. hemoglobin (hgb) values on two successive baseline/screening measurements that average ≥ 11.6g/dl
    Description

    Hemoglobin measurement Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0518015
    UMLS CUI [1,2]
    C1265611
    2. subject with a current malignancy involving a site other than skin
    Description

    Malignant Neoplasm Involving Site | Exception Skin carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C1314939
    UMLS CUI [1,3]
    C1515974
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0699893
    3. subject with a history of drug or alcohol abuse within the last six months
    Description

    Substance Use Disorders

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    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)
    Description

    Completion of clinical trial Unable | Comorbidity | Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2732579
    UMLS CUI [1,2]
    C1299582
    UMLS CUI [2]
    C0009488
    UMLS CUI [3]
    C0023671
    5. subject who the principal investigator considers will be placed at increased risk by the study procedures
    Description

    Study Subject Participation Status Risk Increased

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0035647
    UMLS CUI [1,3]
    C0205217
    6. subject requiring hemodialysis more than 3 times per week on a regular basis.
    Description

    Hemodialysis Regular Frequency Patient need for

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019004
    UMLS CUI [1,2]
    C0205272
    UMLS CUI [1,3]
    C0439603
    UMLS CUI [1,4]
    C0686904
    7. subject who is unable to discontinue oral iron or intravenous iron supplements for the duration of the study
    Description

    Oral ron Discontinue Unable | Intravenous iron Discontinue Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4518405
    UMLS CUI [1,2]
    C1444662
    UMLS CUI [1,3]
    C1299582
    UMLS CUI [2,1]
    C3476073
    UMLS CUI [2,2]
    C1444662
    UMLS CUI [2,3]
    C1299582
    8. subject who is pregnant
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    9. subject considered incompetent to give an informed consent
    Description

    Informed Consent incompetent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0231190
    10. subject with a positive test for hepatitis b surface antigen within the past 30 days or during screening
    Description

    Hepatitis B surface antigen positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0149709
    11. subject with known hiv infection (if this is not known, no hiv testing will be performed)
    Description

    HIV Infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    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
    Description

    Liver Cirrhosis | Ascites | Esophageal Varices | Spider nevus | Hepatic Encephalopathy | Hepatitis C allowed | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023890
    UMLS CUI [2]
    C0003962
    UMLS CUI [3]
    C0014867
    UMLS CUI [4]
    C0085666
    UMLS CUI [5]
    C0019151
    UMLS CUI [6,1]
    C0019196
    UMLS CUI [6,2]
    C0683607
    UMLS CUI [7]
    C0201836
    UMLS CUI [8]
    C0201899
    13. subject with active tuberculosis, fungal, viral, or parasitic infection
    Description

    Tuberculosis | Mycoses | Virus Diseases | Parasitic infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0041296
    UMLS CUI [2]
    C0026946
    UMLS CUI [3]
    C0042769
    UMLS CUI [4]
    C0747256
    14. subject with active bacterial infection requiring antibiotic therapy
    Description

    Bacterial Infection Requirement Antibiotic therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004623
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0338237
    15. subject with pre-dialysis corrected q-wave to t-wave (qtc) interval ≥ 470 milliseconds (ms)
    Description

    QTc interval Pre-dialysis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0489625
    UMLS CUI [1,2]
    C1264634
    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
    Description

    Hypokalemia | Decompensated cardiac failure | Family history of long QT syndrome At risk Torsades de points

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020621
    UMLS CUI [2]
    C0581377
    UMLS CUI [3,1]
    C3839836
    UMLS CUI [3,2]
    C1444641
    UMLS CUI [3,3]
    C3842160
    17. subject using concomitant medications known to prolong qt/qtc interval (see appendix i, table a)
    Description

    Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Prolonged QTc interval

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0678227
    UMLS CUI [1,3]
    C0151878
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0678227
    UMLS CUI [2,3]
    C1560305
    18. subject receiving more than 60,000 units or 120 micrograms of erythropoietin (epogen®, procrit®, or aranesp®) per week
    Description

    Erythropoietin U/week | Epogen | Procrit | Aranesp

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0014822
    UMLS CUI [1,2]
    C0560588
    UMLS CUI [2]
    C0700704
    UMLS CUI [3]
    C0733467
    UMLS CUI [4]
    C1134440
    19. subject has participated in another clinical trial within 30 days of signing informed consent
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
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    Similar models

    Eligibility Chronic Kidney Disease NCT00548249

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    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])
    Item Group
    C0680251 (UMLS CUI)
    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])
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