age
Item
1. Is the Patient a man or woman 18 years of age or older?
boolean
C0001779 (UMLS CUI [1])
Item
2. If the patient is currently taking phosphate binder(s) are they willing to stop this and enter a 2 week washout period?
integer
C2347852 (UMLS CUI [1,1])
C0357221 (UMLS CUI [1,2])
Code List
2. If the patient is currently taking phosphate binder(s) are they willing to stop this and enter a 2 week washout period?
fasting or dieting
Item
3. Is the patient willing to avoid any intentional changes in diet such as fasting or dieting?
boolean
C0015663 (UMLS CUI [1])
C2945766 (UMLS CUI [2])
Item
4. If the patient is currently not taking a phosphate binder, does the patient have a Serum phosphorus measurement of >=5.5mg/dL (1.76 mmol/L) at Screening? (If taking a phosphate binder(s) at Screening, please tick NA)
integer
C0202178 (UMLS CUI [1])
Code List
4. If the patient is currently not taking a phosphate binder, does the patient have a Serum phosphorus measurement of >=5.5mg/dL (1.76 mmol/L) at Screening? (If taking a phosphate binder(s) at Screening, please tick NA)
hydroxyvitamin D and iPTH
Item
5. Does the patient have the following central laboratory measurements: a) 25-hydroxyvitamin-D >=10 ng/mL b) iPTH <=800 pg/mL
boolean
C0535968 (UMLS CUI [1])
C0202159 (UMLS CUI [2])
compliant to sevelamer carbonate
Item
6. Is the patient willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study?
boolean
C1321605 (UMLS CUI [1,1])
C1721288 (UMLS CUI [1,2])
stable doses
Item
7. Is the patient willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet for the duration of the study, except for safety reasons?
boolean
C0678766 (UMLS CUI [1,1])
C0042866 (UMLS CUI [1,2])
C1337242 (UMLS CUI [1,3])
contact to aluminium, magnesium, calcium or lanthanum
Item
8. Is the patient willing and able to avoid antacids and phosphate binders containing aluminium, magnesium, calcium or lanthanum for the duration of the study, except for safety reasons?
boolean
C0002367 (UMLS CUI [1])
C0006675 (UMLS CUI [2])
C0024467 (UMLS CUI [3])
C0023031 (UMLS CUI [4])
Item
9. If female and of childbearing potential (pre-menopausal and not surgically steril), is the patient willing to use an effective contraceptive method throughout study, which includes barrier methods, Hormones, or IUDs?
integer
C0700589 (UMLS CUI [1])
Code List
9. If female and of childbearing potential (pre-menopausal and not surgically steril), is the patient willing to use an effective contraceptive method throughout study, which includes barrier methods, Hormones, or IUDs?
dialysis
Item
10. Is the patient expected not to initiate dialysis for the duration of this study?
boolean
C0011946 (UMLS CUI [1])
compliant to phosphate binders
Item
11. Is the patient considered compliant with phosphate binders (if applicable)?
boolean
C1321605 (UMLS CUI [1,1])
C4020599 (UMLS CUI [1,2])
informed consent
Item
12. Is the patient willing and able to provide informed consent?
boolean
C0021430 (UMLS CUI [1])
study participation status
Item
13. Has the patient not participated in any other investigational drug studies within 30 days prior to enrollment?
boolean
C2348568 (UMLS CUI [1])
study compliance
Item
14. Does the patient have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel?
boolean
C1321605 (UMLS CUI [1])
bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders
Item
1. Does the patient have active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders?
boolean
C0021843 (UMLS CUI [1])
C0011168 (UMLS CUI [2])
C0011168 (UMLS CUI [3])
C0854121 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
active substance abuse
Item
2. Does the patient have an active Ethanol or drug abuse, excluding tobacco use?
boolean
C0038586 (UMLS CUI [1])
use of anti-arrhythmic or anti-seizure drugs
Item
3. Does the patient use anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders?
boolean
C0003195 (UMLS CUI [1,1])
C0003286 (UMLS CUI [1,2])
unstable comorbidity
Item
4. In the opinion of the investigator, does the patient have poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition?
boolean
C0009488 (UMLS CUI [1])
pregnant or breast-feeding
Item
5. If female, is the patient pregnant or breast feeding?
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
malignant neoplasms
Item
6. Does the patient have any evidence of active malignancy except for basal cell carcinoma of the skin?
boolean
C0006826 (UMLS CUI [1])
study protocol compliance
Item
7. Is the patient unable to comply with the requirements of the study?
boolean
C2348563 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
hypersensitivity to study drug
Item
8. Does the patient have a known hypersensitivity to sevelamer or any constituents of the study drug?
boolean
C0020517 (UMLS CUI [1,1])
C071805 (UMLS CUI [1,2])
comorbidity prohibiting study inclusion
Item
9. Does the patient have any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study?
boolean
C0009488 (UMLS CUI [1])
date informed consent signed
Item
Date Informed Consent signed
date
C2985782 (UMLS CUI [1])
Patient met all enrollment criteria?
Item
Patient met all enrollment criteria?
boolean
C1302261 (UMLS CUI [1])
date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Ethnicity:
integer
C0015031 (UMLS CUI [1])
if previous answered with other, please specify
Item
if previous answered with other, please specify:
text
C0015031 (UMLS CUI [1])
Item
Sex:
integer
C0079399 (UMLS CUI [1])
Smoker
Item
Smoker?
boolean
C0543414 (UMLS CUI [1])
Diabetes mellitus
Item
Diabetes mellitus?
boolean
C0011849 (UMLS CUI [1])