ID

35920

Beskrivning

This trial is designed to determine whether rapamycin is safe and effective treatment for patients with polycystic kidney disease (ADPKD). Patients will be followed by volumetric magnetic resonance imaging (MRI) to observe for change in kidney (and cyst) size. Blood and urine samples will also be collected to evaluate for change in biomarkers with treatment. ODM derived from: https://clinicaltrials.gov/show/NCT00920309

Länk

https://clinicaltrials.gov/show/NCT00920309

Nyckelord

Versioner (1)
  1. 2019-04-04 2019-04-04 -
Rättsinnehavare

Yale University

Uppladdad den

4 april 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease NCT00920309

Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patient with ADPKD aged 18-70
Beskrivning

ADPKD = autosomal dominant polycystic kidney disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0001675
UMLS CUI [1,3]
C0085413
Patient with a combined kidney volume >1200 ml
Beskrivning

Kidney volume

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2827452
UMLS CUI [1,2]
C0205195
Patient with an estimated creatinine clearance >60 ml/min
Beskrivning

Creatinine clearance

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
Patient has no implanted ferromagnetic objects
Beskrivning

Ferromagnetic implants

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3693688
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patient aged >70
Beskrivning

Elderly people

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Patient with uncontrolled hyperlipidemia
Beskrivning

Hyperlipidemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020473
UMLS CUI [1,2]
C0205318
Patient with proteinuria >500 mg/day
Beskrivning

Proteinuria

Datatyp

boolean

Alias
UMLS CUI [1]
C0033687
Patient with an unstable cerebral aneurysm
Beskrivning

Cerebral aneurysm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0917996
UMLS CUI [1,2]
C0443343
Patient with an active coronary artery disease
Beskrivning

Coronary artery disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0205177
Patient diagnosed with another systemic condition affecting kidney function (ie: diabetes, hepatitis b or c, hiv)
Beskrivning

Comorbidity affecting kidney function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0392760
Patient diagnosed with cancer other than skin cancer
Beskrivning

Cancer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0699893
Patient is pregnant or breastfeeding
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Patients has implanted ferromagnetic objects
Beskrivning

Ferromagnetic implants

Datatyp

boolean

Alias
UMLS CUI [1]
C3693688
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Patient with ADPKD aged 18-70
boolean
C0001779 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
C0085413 (UMLS CUI [1,3])
Kidney volume
Item
Patient with a combined kidney volume >1200 ml
boolean
C2827452 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
Creatinine clearance
Item
Patient with an estimated creatinine clearance >60 ml/min
boolean
C0373595 (UMLS CUI [1])
Ferromagnetic implants
Item
Patient has no implanted ferromagnetic objects
boolean
C3693688 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Elderly people
Item
Patient aged >70
boolean
C0001779 (UMLS CUI [1])
Hyperlipidemia
Item
Patient with uncontrolled hyperlipidemia
boolean
C0020473 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Proteinuria
Item
Patient with proteinuria >500 mg/day
boolean
C0033687 (UMLS CUI [1])
Cerebral aneurysm
Item
Patient with an unstable cerebral aneurysm
boolean
C0917996 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Coronary artery disease
Item
Patient with an active coronary artery disease
boolean
C1956346 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Comorbidity affecting kidney function
Item
Patient diagnosed with another systemic condition affecting kidney function (ie: diabetes, hepatitis b or c, hiv)
boolean
C0442893 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
Cancer
Item
Patient diagnosed with cancer other than skin cancer
boolean
C0027651 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0699893 (UMLS CUI [1,3])
Pregnancy
Item
Patient is pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Ferromagnetic implants
Item
Patients has implanted ferromagnetic objects
boolean
C3693688 (UMLS CUI [1])
Tillbaka till toppen 

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