ID

44248

Beschrijving

Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT00704678

Link

https://clinicaltrials.gov/show/NCT00704678

Trefwoorden

  1. 06-12-17 06-12-17 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Chronic Kidney Disease NCT00704678

Eligibility Chronic Kidney Disease NCT00704678

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women of at least 18 years old or 20 years old in japan.
Beschrijving

Age | Japan

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0022341
stable maintenance of hemodialysis 3 times per week.
Beschrijving

Hemodialysis Stable Frequency

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0439603
controlled serum phosphate if under phosphate-binder therapy.
Beschrijving

Serum Phosphate Controlled | Phosphate Binder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036820
UMLS CUI [1,2]
C2587213
UMLS CUI [2]
C2267031
serum phosphate level > 6.0 mg/dl (> 1.9 mmol/l) prior to study treatment initiation.
Beschrijving

Serum Phosphate Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1883013
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
peritoneal dialysis or a non-conventional hemodialysis technique .
Beschrijving

Peritoneal Dialysis | Hemodialysis experimental

Datatype

boolean

Alias
UMLS CUI [1]
C0031139
UMLS CUI [2,1]
C0019004
UMLS CUI [2,2]
C1517586
parathyroidectomy or transplant scheduled during the study.
Beschrijving

Parathyroidectomy | Transplantation Scheduled

Datatype

boolean

Alias
UMLS CUI [1]
C0079989
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C0205539
uncontrolled hyperparathyroidism
Beschrijving

Hyperparathyroidism Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020502
UMLS CUI [1,2]
C0205318
history of hemochromatosis or ferritin > 800 µg/l.
Beschrijving

Hemochromatosis | Ferritin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0018995
UMLS CUI [2]
C0373607
clinically significant gi disorder
Beschrijving

Gastrointestinal Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0017178
unstable medical condition other than chronic kidney disease.
Beschrijving

Medical condition Unstable | Exception Chronic Kidney Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1561643
treated with sevelamer hcl monotherapy or sbr759.
Beschrijving

Sevelamer hcl | SBR 759

Datatype

boolean

Alias
UMLS CUI [1]
C0772463
UMLS CUI [2]
C3490450
treated with oral iron.
Beschrijving

Oral iron

Datatype

boolean

Alias
UMLS CUI [1]
C4518405
other protocol-defined inclusion/exclusion criteria may apply.
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Chronic Kidney Disease NCT00704678

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Japan
Item
men or women of at least 18 years old or 20 years old in japan.
boolean
C0001779 (UMLS CUI [1])
C0022341 (UMLS CUI [2])
Hemodialysis Stable Frequency
Item
stable maintenance of hemodialysis 3 times per week.
boolean
C0019004 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serum Phosphate Controlled | Phosphate Binder
Item
controlled serum phosphate if under phosphate-binder therapy.
boolean
C0036820 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
C2267031 (UMLS CUI [2])
Serum Phosphate Measurement
Item
serum phosphate level > 6.0 mg/dl (> 1.9 mmol/l) prior to study treatment initiation.
boolean
C1883013 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Peritoneal Dialysis | Hemodialysis experimental
Item
peritoneal dialysis or a non-conventional hemodialysis technique .
boolean
C0031139 (UMLS CUI [1])
C0019004 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Parathyroidectomy | Transplantation Scheduled
Item
parathyroidectomy or transplant scheduled during the study.
boolean
C0079989 (UMLS CUI [1])
C0040732 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Hyperparathyroidism Uncontrolled
Item
uncontrolled hyperparathyroidism
boolean
C0020502 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hemochromatosis | Ferritin measurement
Item
history of hemochromatosis or ferritin > 800 µg/l.
boolean
C0018995 (UMLS CUI [1])
C0373607 (UMLS CUI [2])
Gastrointestinal Diseases
Item
clinically significant gi disorder
boolean
C0017178 (UMLS CUI [1])
Medical condition Unstable | Exception Chronic Kidney Diseases
Item
unstable medical condition other than chronic kidney disease.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1561643 (UMLS CUI [2,2])
Sevelamer hcl | SBR 759
Item
treated with sevelamer hcl monotherapy or sbr759.
boolean
C0772463 (UMLS CUI [1])
C3490450 (UMLS CUI [2])
Oral iron
Item
treated with oral iron.
boolean
C4518405 (UMLS CUI [1])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

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