ID

35920

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00920309

Stichworte

Versionen (1)
  1. 04.04.19 04.04.19 -
Rechteinhaber

Yale University

Hochgeladen am

4. April 2019

DOI

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Lizenz

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

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

ADPKD = autosomal dominant polycystic kidney disease

Datentyp

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
Beschreibung

Kidney volume

Datentyp

boolean

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

Creatinine clearance

Datentyp

boolean

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

Ferromagnetic implants

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patient aged >70
Beschreibung

Elderly people

Datentyp

boolean

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

Hyperlipidemia

Datentyp

boolean

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

Proteinuria

Datentyp

boolean

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

Cerebral aneurysm

Datentyp

boolean

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

Coronary artery disease

Datentyp

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)
Beschreibung

Comorbidity affecting kidney function

Datentyp

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
Beschreibung

Cancer

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

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

Ferromagnetic implants

Datentyp

boolean

Alias
UMLS CUI [1]
C3693688
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

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