ID

35938

Description

The general aim of the trial is to assess the efficacy of one year treatment with long-acting somatostatin analogue (Octreotide LAR) compared with placebo in slowing kidney and liver growth rate in patients with ADPKD and moderate/severe renal insufficiency and to assess whether and to which extent this translates into slower renal function decline over 3-year follow-up. ODM derived from: https://clinicaltrials.gov/show/NCT01377246

Link

https://clinicaltrials.gov/show/NCT01377246

Keywords

  1. 4/4/19 4/4/19 -
  2. 4/5/19 4/5/19 -
Copyright Holder

Mario Negri Institute for Pharmacological Research

Uploaded on

April 5, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Somatostatin In Patients With ADPKD And Moderate To Severe Renal Insufficiency NCT01377246

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patient aged > 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Patient with a clinical and ultrasound diagnosis of adpkd
Description

ADPKD = autosomal dominant polycystic kidney disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0085413
UMLS CUI [1,2]
C0332140
UMLS CUI [2,1]
C0085413
UMLS CUI [2,2]
C0041618
Patient with an estimated GFR between 15 and 40 ml/min/1.73m2 (by the mdrd 4 variable equation)
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C2170215
UMLS CUI [1,2]
C0439801
Patient signed informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patient with 24-h urinary protein excretion rate >3g (suggestive of a concomitant glomerular disease that could benefit of specific therapy)
Description

Urinary protein excretion rate

Data type

boolean

Alias
UMLS CUI [1,1]
C3897352
UMLS CUI [1,2]
C3163633
UMLS CUI [2,1]
C0268731
UMLS CUI [2,2]
C0243087
UMLS CUI [2,3]
C0332299
Patient with symptomatic urinary tract lithiasis or obstruction
Description

Urinary tract lithiasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0451641
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0178879
UMLS CUI [2,2]
C0231220
Patient with uncontrolled diabetes mellitus (HbA1c >8%) or hypertension (systolic/diastolic bp >180/110 mmHg)
Description

(HbA1c >8%)

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1868885
Patient has a current urinary tract infection
Description

Urinary tract infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0042029
UMLS CUI [1,2]
C0521116
Patient has a symptomatic biliary tract lithiasis
Description

Biliary tract lithiasis

Data type

boolean

Alias
UMLS CUI [1,1]
C4228051
UMLS CUI [1,2]
C0231220
Patient with active cancer
Description

Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0205177
Patient has a psychiatric disorder or any condition that might prevent full comprehension of the purposes and risks of the study
Description

Psychiatric disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C0681832
UMLS CUI [1,4]
C0439801
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C0035647
UMLS CUI [2,4]
C0439801
Patient is pregnant, breastfeeding or has a child bearing potential and uses ineffective contraception
Description

estrogen therapy in post menopausal women should not be stopped

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C3242229

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Patient aged > 18 years
boolean
C0001779 (UMLS CUI [1])
ADPKD
Item
Patient with a clinical and ultrasound diagnosis of adpkd
boolean
C0085413 (UMLS CUI [1,1])
C0332140 (UMLS CUI [1,2])
C0085413 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
Renal function
Item
Patient with an estimated GFR between 15 and 40 ml/min/1.73m2 (by the mdrd 4 variable equation)
boolean
C2170215 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Informed consent
Item
Patient signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Urinary protein excretion rate
Item
Patient with 24-h urinary protein excretion rate >3g (suggestive of a concomitant glomerular disease that could benefit of specific therapy)
boolean
C3897352 (UMLS CUI [1,1])
C3163633 (UMLS CUI [1,2])
C0268731 (UMLS CUI [2,1])
C0243087 (UMLS CUI [2,2])
C0332299 (UMLS CUI [2,3])
Urinary tract lithiasis
Item
Patient with symptomatic urinary tract lithiasis or obstruction
boolean
C0451641 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0178879 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Metabolic syndrom
Item
Patient with uncontrolled diabetes mellitus (HbA1c >8%) or hypertension (systolic/diastolic bp >180/110 mmHg)
boolean
C0011849 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
Urinary tract infection
Item
Patient has a current urinary tract infection
boolean
C0042029 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Biliary tract lithiasis
Item
Patient has a symptomatic biliary tract lithiasis
boolean
C4228051 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Cancer
Item
Patient with active cancer
boolean
C0027651 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Psychiatric disorders
Item
Patient has a psychiatric disorder or any condition that might prevent full comprehension of the purposes and risks of the study
boolean
C0004936 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C0681832 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
Pregnancy and contraception
Item
Patient is pregnant, breastfeeding or has a child bearing potential and uses ineffective contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3242229 (UMLS CUI [3,3])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial