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ID
23600
Description
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
Keywords
Versions (3)
- 7/9/17 7/9/17 -
- 12/28/17 12/28/17 -
- 9/20/21 9/20/21 -
Uploaded on
July 9, 2017
DOI
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License
Creative Commons BY-NC-ND 3.0
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Eligibility Anemia NCT02905539 DRKS00010766
Eligibility Anemia NCT02905539 DRKS00010766
- StudyEvent: ODM
Similar models
Eligibility Anemia NCT02905539 DRKS00010766
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
C1744706 (UMLS CUI [1,2])
Glomerular Filtration Rate
Item
Estimated Glomerular Filtration Rate > 15 ml/min/1.73 m²
boolean
C0017654 (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])
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])
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])
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])
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])
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])
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])