ID

35938

Beschreibung

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

Stichworte

Versionen (2)
  1. 04.04.19 04.04.19 -
  2. 05.04.19 05.04.19 -
Rechteinhaber

Mario Negri Institute for Pharmacological Research

Hochgeladen am

5. April 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Somatostatin In Patients With ADPKD And Moderate To Severe Renal Insufficiency NCT01377246

Englisch

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patient aged > 18 years
Beschreibung

Age

Datentyp

boolean

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

ADPKD = autosomal dominant polycystic kidney disease

Datentyp

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)
Beschreibung

Renal function

Datentyp

boolean

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

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

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)
Beschreibung

Urinary protein excretion rate

Datentyp

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
Beschreibung

Urinary tract lithiasis

Datentyp

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)
Beschreibung

(HbA1c >8%)

Datentyp

boolean

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

Urinary tract infection

Datentyp

boolean

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

Biliary tract lithiasis

Datentyp

boolean

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

Cancer

Datentyp

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
Beschreibung

Psychiatric disorders

Datentyp

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
Beschreibung

estrogen therapy in post menopausal women should not be stopped

Datentyp

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
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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 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])
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