ID

23600

Descripción

Responsible Party: Saarland University ClinicalTrials.gov Identifier: NCT02905539 History of Changes Other Study ID Numbers: P-0101 2015-004808-36 ( EudraCT Number ) U1111-1176-4563 ( Registry Identifier: WHO Universal Trial Number ) DRKS00010766 ( Registry Identifier: Deutsches Register Klinischer Studien ) Study First Received: September 8, 2016 Last Updated: September 13, 2016 A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer (HOMe_aFers_1) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02905539

Link

https://clinicaltrials.gov/ct2/show/NCT02905539

Palabras clave

Versiones (3)
  1. 9/7/17 9/7/17 -
  2. 28/12/17 28/12/17 -
  3. 20/9/21 20/9/21 -
Subido en

9 de julio de 2017

DOI

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Licencia

Creative Commons BY-NC-ND 3.0
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Eligibility Anemia NCT02905539 DRKS00010766

Inglés

Eligibility Anemia NCT02905539 DRKS00010766

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Written informed consent,
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Female,
Descripción

Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
Gynecological blood losses,
Descripción

Gynecological blood losses

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018417
UMLS CUI [1,2]
C3163616
Age ≥ 18 years,
Descripción

Age

Tipo de datos

boolean

Iron deficiency anemia,
Descripción

Iron deficiency anemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0162316
Hemoglobin < 12,0 g/dl,
Descripción

Hemoglobin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019046
Serum-Ferritin ≤ 100 ng/ml or Serum-Ferritin ≤ 300 ng/ml and Transferrin-saturation ≤ 30 %,
Descripción

Serum-Ferritin, Transferrin-saturation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0696113
UMLS CUI [2]
C1277709
Intolerance to or inefficacy of an oral iron supplement
Descripción

Intolerance to oral iron supplement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0721124
UMLS CUI [1,2]
C1744706
Estimated Glomerular Filtration Rate > 15 ml/min/1.73 m²
Descripción

Glomerular Filtration Rate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017654
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Descripción

Control Group

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009932
Known hypersensitivity to MonoFer® or FERINJECT®,
Descripción

Hypersensitivity to iron supplement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0721124
Severe, known hypersensitivity to other intravenous iron preparations,
Descripción

Hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020517
Plasma Phosphate < 2.5 mg/dl at screening,
Descripción

Plasma Phosphate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1276038
Hemochromatosis,
Descripción

Hemochromatosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018995
Untreated hyperparathyroidism,
Descripción

Hyperparathyroidism

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020502
Renal replacement therapy/kidney transplantation,
Descripción

Renal replacement therapy, Kidney transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206074
UMLS CUI [2]
C0022671
Active malignant disease, disease-free survival for less than 5 years,
Descripción

Malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
Intravenous iron administration within the last 30 days,
Descripción

Intravenous iron administration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013125
UMLS CUI [1,2]
C0721124
Treatment with erythropoietin or erythropoietin-stimulating agents, transfusion of red blood cells, radiotherapy or chemotherapy within the last 60 days,
Descripción

Treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
Surgery under anesthetic within the last 10 days,
Descripción

Surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543467
Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 fold above levels in healthy individuals,
Descripción

ALT, AST

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
Acute febrile infections within the last 7 days,
Descripción

Febrile infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948233
Chronic inflammatory diseases requiring a systemic antiinflammatory treatment,
Descripción

Chronic inflammatory diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1290886
self-reported severe asthma or eczema,
Descripción

Asthma or eczema

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0013595
Presence of relative contraindications (any allergy, any immunologic or inflammatory disease, history of atopic allergies), for which a treatment with the medicinal investigational products is not deemed indicated by the investigator,
Descripción

Contraindication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1301624
Pregnancy,
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
Women of childbearing potential without an effective method of contraception,
Descripción

Contraceptive Methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
Lactating women,
Descripción

Lactating

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2828358
Present alcohol or drug dependency,
Descripción

Substance Use Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
Patients with a history of a psychological illness or seizures,
Descripción

Mental disorder, Seizures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0036572
Non-compliance or administration of any investigational drug within 30 days preceding the study start.
Descripción

Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Anemia NCT02905539 DRKS00010766

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed Consent
Item
Written informed consent,
boolean
C0021430 (UMLS CUI [1])
Gender
Item
Female,
boolean
C0079399 (UMLS CUI [1])
Gynecological blood losses
Item
Gynecological blood losses,
boolean
C0018417 (UMLS CUI [1,1])
C3163616 (UMLS CUI [1,2])
Age
Item
Age ≥ 18 years,
boolean
Iron deficiency anemia
Item
Iron deficiency anemia,
boolean
C0162316 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin < 12,0 g/dl,
boolean
C0019046 (UMLS CUI [1])
Serum-Ferritin, Transferrin-saturation
Item
Serum-Ferritin ≤ 100 ng/ml or Serum-Ferritin ≤ 300 ng/ml and Transferrin-saturation ≤ 30 %,
boolean
C0696113 (UMLS CUI [1])
C1277709 (UMLS CUI [2])
Intolerance to oral iron supplement
Item
Intolerance to or inefficacy of an oral iron supplement
boolean
C0721124 (UMLS CUI [1,1])
C1744706 (UMLS CUI [1,2])
Glomerular Filtration Rate
Item
Estimated Glomerular Filtration Rate > 15 ml/min/1.73 m²
boolean
C0017654 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Hypersensitivity to iron supplement
Item
Known hypersensitivity to MonoFer® or FERINJECT®,
boolean
C0020517 (UMLS CUI [1,1])
C0721124 (UMLS CUI [1,2])
Hypersensitivity
Item
Severe, known hypersensitivity to other intravenous iron preparations,
boolean
C0020517 (UMLS CUI [1])
Plasma Phosphate
Item
Plasma Phosphate < 2.5 mg/dl at screening,
boolean
C1276038 (UMLS CUI [1])
Hemochromatosis
Item
Hemochromatosis,
boolean
C0018995 (UMLS CUI [1])
Hyperparathyroidism
Item
Untreated hyperparathyroidism,
boolean
C0020502 (UMLS CUI [1])
Renal replacement therapy, Kidney transplantation
Item
Renal replacement therapy/kidney transplantation,
boolean
C0206074 (UMLS CUI [1])
C0022671 (UMLS CUI [2])
Malignancy
Item
Active malignant disease, disease-free survival for less than 5 years,
boolean
C0006826 (UMLS CUI [1])
Intravenous iron administration
Item
Intravenous iron administration within the last 30 days,
boolean
C0013125 (UMLS CUI [1,1])
C0721124 (UMLS CUI [1,2])
Treatment
Item
Treatment with erythropoietin or erythropoietin-stimulating agents, transfusion of red blood cells, radiotherapy or chemotherapy within the last 60 days,
boolean
C0087111 (UMLS CUI [1])
Surgery
Item
Surgery under anesthetic within the last 10 days,
boolean
C0543467 (UMLS CUI [1])
ALT, AST
Item
Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 fold above levels in healthy individuals,
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Febrile infection
Item
Acute febrile infections within the last 7 days,
boolean
C0948233 (UMLS CUI [1])
Chronic inflammatory diseases
Item
Chronic inflammatory diseases requiring a systemic antiinflammatory treatment,
boolean
C1290886 (UMLS CUI [1])
Asthma or eczema
Item
self-reported severe asthma or eczema,
boolean
C0004096 (UMLS CUI [1])
C0013595 (UMLS CUI [2])
Contraindication
Item
Presence of relative contraindications (any allergy, any immunologic or inflammatory disease, history of atopic allergies), for which a treatment with the medicinal investigational products is not deemed indicated by the investigator,
boolean
C1301624 (UMLS CUI [1])
Pregnancy
Item
Pregnancy,
boolean
C0032961 (UMLS CUI [1])
Contraceptive Methods
Item
Women of childbearing potential without an effective method of contraception,
boolean
C0700589 (UMLS CUI [1])
Lactating
Item
Lactating women,
boolean
C2828358 (UMLS CUI [1])
Substance Use Disorder
Item
Present alcohol or drug dependency,
boolean
C0038586 (UMLS CUI [1])
Mental disorder, Seizures
Item
Patients with a history of a psychological illness or seizures,
boolean
C0004936 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Compliance
Item
Non-compliance or administration of any investigational drug within 30 days preceding the study start.
boolean
C1321605 (UMLS CUI [1])
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