ID

31627

Description

Study of Lanreotide to Treat Polycystic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01616927 Sponsor: University Medical Center Groningen Collaborators: Leiden University Medical Center Erasmus Medical Center Radboud University Principal Investigator: Ron Gansevoort, MD, PhD University Medical Centre

Lien

https://clinicaltrials.gov/show/NCT01616927

Mots-clés

Versions (1)
  1. 14/09/2018 14/09/2018 -
Détendeur de droits

dr. R.T. Gansevoort, Associate Professor in Nephrology, University Medical Center Groningen

Téléchargé le

14 septembre 2018

DOI

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Licence

Creative Commons BY-NC 3.0
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Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01616927

Anglais

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01616927

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of adpkd, based upon the modified ravine criteria
Description

Diagnosis of adpkd, based upon the modified ravine criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085413
UMLS CUI [1,2]
C0679228
2. age between 18 and 60 years.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. egfr (mdrd) between 30 and 60 ml/min/1.73 m2.
Description

egfr estimated by mdrd formula

Type de données

boolean

Alias
UMLS CUI [1]
C2170215
4. providing informed consent.
Description

Informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who, in the opinion of the study investigator, may present a safety risk.
Description

Patients who, in the opinion of the study investigator, may present a safety risk.

Type de données

boolean

Alias
UMLS CUI [1,1]
C2911688
UMLS CUI [1,2]
C0871010
UMLS CUI [1,3]
C1710101
2. patients who are unlikely to adequately comply with the trial's procedures [due for instance to medical conditions likely to require an extended interruption or discontinuation, history of substance abuse or noncompliance).
Description

Noncompliance, e.g. due to medical conditions requiring discontinuation or history of substance abuse

Type de données

boolean

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1299544
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0525058
3. a. patients taking medications or having concomitant illnesses likely to confound endpoint assessments (e.g. nephrotoxic medications such as chronic nsaid, cyclosporine, lithium immunosuppressant use) b. patients having concomitant illnesses likely to confound endpoint assessments (e.g. diabetes mellitus for which medication is needed and patients with proteinuria > 1 g /24hr).
Description

Comorbidities or concomitant medication likely to confound endpoint assessment, e.g. nephrotoxic drugs or diabetes mellitus, proteinuria

Type de données

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C2603343
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C2603343
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0013227
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0599918
UMLS CUI [5]
C0033687
4. patients who underwent surgical or drainage interventions for cystic kidney disease the year before study-entry or are likely candidates for these procedures within 2 years of start of the study.
Description

History of recent or upcoming surgical or drainage interventions for cystic kidney disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C4035998
UMLS CUI [1,3]
C1691228
UMLS CUI [2,1]
C0750492
UMLS CUI [2,2]
C1548635
UMLS CUI [2,3]
C0013103
UMLS CUI [2,4]
C1691228
UMLS CUI [3,1]
C0750492
UMLS CUI [3,2]
C1548635
UMLS CUI [3,3]
C0543467
UMLS CUI [3,4]
C1691228
5. patients taking other experimental (i.e.,non approved by fda/ema or indication of adpkd) therapies.
Description

Concomitant experimental therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C0304229
6. patients having used lanreotide (or another somatostatin analogue) in the 3 months before study start.
Description

Recent intake of somatostatin analogue

Type de données

boolean

Alias
UMLS CUI [1,1]
C0732165
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0209211
7. patients with known intolerance for lanreotide (or another somatostatin analogue).
Description

Known intolerance for lanreotide or another somatostatin analogue

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0732165
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0209211
8. unwillingness to comply with reproductive precautions. women who are capable of becoming pregnant must be willing to comply with approved birth control from two-weeks prior to, and for 60 days after taking investigational product.
Description

Unwillingness to use proper contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
9. women, who are pregnant or breastfeeding.
Description

Pregnancy or breastfeeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
10. patients, who suffer from cardiac arrhythmias, that are thought to be dangerous in combination with lanreotide administration.
Description

Cardiac arrhythmias contraindicating lanreotide administration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0209211
11. patients, who ever suffered from symptomatic gallstones and did not undergo cholecystectomy.
Description

History of symptomatic gallstones without cholecystectomy

Type de données

boolean

Alias
UMLS CUI [1,1]
C1561969
UMLS CUI [1,2]
C0008320
UMLS CUI [1,3]
C0332197
12. patients, who have a medical history of pancreatitis.
Description

History of pancreatitis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030305
UMLS CUI [1,2]
C0262926
13. patients, who have a medical history of infected liver cysts.
Description

History of infected liver cysts

Type de données

boolean

Alias
UMLS CUI [1,1]
C0267834
UMLS CUI [1,2]
C3714514
UMLS CUI [1,3]
C0262926
In Addition
Description

In Addition

Alias
UMLS CUI-1
C0242801
patients, who underwent liver cyst drainage or surgery in the year before, can enter the study, but will not be assessed for change in liver volume.
Description

History of recent liver cyst drainge or surgery

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0267834
UMLS CUI [1,3]
C0013103
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0267834
UMLS CUI [2,3]
C0543467
patients having contraindications to, or interference with mri assessments, as dictated by local regulation, will not be allowed to undergo mr imaging. however, these patients can enter the study, but will not be assessed for change in kidney and/or liver volume.
Description

Contraindications to or interference with mri assessments

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0521102
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C1301624
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Similar models

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01616927

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diagnosis of adpkd, based upon the modified ravine criteria
Item
1. diagnosis of adpkd, based upon the modified ravine criteria
boolean
C0085413 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
Age
Item
2. age between 18 and 60 years.
boolean
C0001779 (UMLS CUI [1])
egfr estimated by mdrd formula
Item
3. egfr (mdrd) between 30 and 60 ml/min/1.73 m2.
boolean
C2170215 (UMLS CUI [1])
Informed consent
Item
4. providing informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patients who, in the opinion of the study investigator, may present a safety risk.
Item
1. patients who, in the opinion of the study investigator, may present a safety risk.
boolean
C2911688 (UMLS CUI [1,1])
C0871010 (UMLS CUI [1,2])
C1710101 (UMLS CUI [1,3])
Noncompliance, e.g. due to medical conditions requiring discontinuation or history of substance abuse
Item
2. patients who are unlikely to adequately comply with the trial's procedures [due for instance to medical conditions likely to require an extended interruption or discontinuation, history of substance abuse or noncompliance).
boolean
C0457432 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1299544 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Comorbidities or concomitant medication likely to confound endpoint assessment, e.g. nephrotoxic drugs or diabetes mellitus, proteinuria
Item
3. a. patients taking medications or having concomitant illnesses likely to confound endpoint assessments (e.g. nephrotoxic medications such as chronic nsaid, cyclosporine, lithium immunosuppressant use) b. patients having concomitant illnesses likely to confound endpoint assessments (e.g. diabetes mellitus for which medication is needed and patients with proteinuria > 1 g /24hr).
boolean
C2347852 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C2603343 (UMLS CUI [2,3])
C0011849 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0599918 (UMLS CUI [4,2])
C0033687 (UMLS CUI [5])
History of recent or upcoming surgical or drainage interventions for cystic kidney disease
Item
4. patients who underwent surgical or drainage interventions for cystic kidney disease the year before study-entry or are likely candidates for these procedures within 2 years of start of the study.
boolean
C0332185 (UMLS CUI [1,1])
C4035998 (UMLS CUI [1,2])
C1691228 (UMLS CUI [1,3])
C0750492 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C0013103 (UMLS CUI [2,3])
C1691228 (UMLS CUI [2,4])
C0750492 (UMLS CUI [3,1])
C1548635 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
C1691228 (UMLS CUI [3,4])
Concomitant experimental therapy
Item
5. patients taking other experimental (i.e.,non approved by fda/ema or indication of adpkd) therapies.
boolean
C1707479 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Recent intake of somatostatin analogue
Item
6. patients having used lanreotide (or another somatostatin analogue) in the 3 months before study start.
boolean
C0732165 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0209211 (UMLS CUI [2,2])
Known intolerance for lanreotide or another somatostatin analogue
Item
7. patients with known intolerance for lanreotide (or another somatostatin analogue).
boolean
C0020517 (UMLS CUI [1,1])
C0732165 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0209211 (UMLS CUI [2,2])
Unwillingness to use proper contraceptive methods
Item
8. unwillingness to comply with reproductive precautions. women who are capable of becoming pregnant must be willing to comply with approved birth control from two-weeks prior to, and for 60 days after taking investigational product.
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Pregnancy or breastfeeding
Item
9. women, who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiac arrhythmias contraindicating lanreotide administration
Item
10. patients, who suffer from cardiac arrhythmias, that are thought to be dangerous in combination with lanreotide administration.
boolean
C0003811 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0209211 (UMLS CUI [1,3])
History of symptomatic gallstones without cholecystectomy
Item
11. patients, who ever suffered from symptomatic gallstones and did not undergo cholecystectomy.
boolean
C1561969 (UMLS CUI [1,1])
C0008320 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
History of pancreatitis
Item
12. patients, who have a medical history of pancreatitis.
boolean
C0030305 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
History of infected liver cysts
Item
13. patients, who have a medical history of infected liver cysts.
boolean
C0267834 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Item Group
In Addition
C0242801 (UMLS CUI-1)
History of recent liver cyst drainge or surgery
Item
patients, who underwent liver cyst drainage or surgery in the year before, can enter the study, but will not be assessed for change in liver volume.
boolean
C0332185 (UMLS CUI [1,1])
C0267834 (UMLS CUI [1,2])
C0013103 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C0267834 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Contraindications to or interference with mri assessments
Item
patients having contraindications to, or interference with mri assessments, as dictated by local regulation, will not be allowed to undergo mr imaging. however, these patients can enter the study, but will not be assessed for change in kidney and/or liver volume.
boolean
C0024485 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
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