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

Uploaded on

September 20, 2021

DOI

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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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