ID

35276

Descrição

A Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT02504294

Link

https://clinicaltrials.gov/show/NCT02504294

Palavras-chave

Versões (1)
  1. 26/02/2019 26/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease (CKD) NCT02504294

Inglês

Eligibility Chronic Kidney Disease (CKD) NCT02504294

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adult female or male subjects; age ≥18 years.
Descrição

Adult | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
2. end stage renal disease subjects treated in-center with the modality of hemodialysis for ≥120 days.
Descrição

Kidney Failure, Chronic | Hemodialysis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0019004
3. diagnosed with anemia.
Descrição

Anemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002871
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.
Descrição

Epogen Intravenous | Anemia | Unit dose Algorithm Erythropoiesis Stimulating Agents

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0700704
UMLS CUI [1,2]
C1522726
UMLS CUI [2]
C0002871
UMLS CUI [3,1]
C0869039
UMLS CUI [3,2]
C0002045
UMLS CUI [3,3]
C1959590
5. currently using the iv epogen version of the esa dosing algorithm cmab 5 for anemia management.
Descrição

Epogen Intravenous | Unit dose Algorithm Erythropoiesis Stimulating Agents | Anemia Management

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0700704
UMLS CUI [1,2]
C1522726
UMLS CUI [2,1]
C0869039
UMLS CUI [2,2]
C0002045
UMLS CUI [2,3]
C1959590
UMLS CUI [3,1]
C0002871
UMLS CUI [3,2]
C0376636
6. receiving hemodialysis at a clinic using the fmcna dosing algorithm for iv iron that is the fmcna standard of care for iron replacement.
Descrição

Hemodialysis | Iron replacement Intravenous | Unit dose Algorithm

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2,1]
C0919650
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C0869039
UMLS CUI [3,2]
C0002045
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects unable to provide a signed and dated informed consent for this clinical research study.
Descrição

Informed Consent Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
2. as determined by the investigator, female subjects of childbearing potential who do not agree to use a highly effective method of contraception.
Descrição

Childbearing Potential Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
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.
Descrição

Condition Study Subject Participation Status At risk | Condition Excludes Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
4. female subjects who are known to be or found to be, pregnant or lactating.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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.
Descrição

Study Subject Inappropriate Erythropoiesis Stimulating Agents | Epogen Package Inserts | Other Coding | Recombinant Erythropoietin Antibodies Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1959590
UMLS CUI [2,1]
C0700704
UMLS CUI [2,2]
C0030174
UMLS CUI [3]
C3846158
UMLS CUI [4,1]
C0376541
UMLS CUI [4,2]
C0003241
UMLS CUI [4,3]
C1514241
6. treatment with any investigational drug within 30 days prior to randomization and throughout this clinical trial.
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
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.
Descrição

Condition Resulting in Blood Loss | Menorrhagia | Peptic Ulcer | Gastrointestinal Hemorrhage | Hematological Disease | Hemoglobinopathy | Anticoagulation Therapy | Exception Dialysis | Exception Aspirin therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C3163616
UMLS CUI [2]
C0025323
UMLS CUI [3]
C0030920
UMLS CUI [4]
C0017181
UMLS CUI [5]
C0018939
UMLS CUI [6]
C0019045
UMLS CUI [7]
C0003281
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0011946
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C4303556
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.
Descrição

Blood Transfusion Quantity | Blood Donation Amount | Blood Loss Amount | Plasmapheresis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C3163616
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0032134
9. subjects currently receiving a long acting esa, or who have received a long acting esa in the 16 weeks prior to study randomization.
Descrição

Erythropoiesis Stimulating Agents Active Long-term

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1959590
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0443252
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Similar models

Eligibility Chronic Kidney Disease (CKD) NCT02504294

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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