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])
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])
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])