Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT01354405
Eligibility Criteria:
Inclusion Criteria:
* Patients with ADPKD with polycystic liver (\> 20 liver cysts)
* Renal function MDRD \>40 ml/hr
* Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements
Exclusion Criteria:
* Kidney transplantation
* Renal failure requiring hemodialysis
* Use of oral contraceptives or estrogen suppletion
* Women who are pregnant or breastfeeding
* History of cardiac/pulmonary disease; symptomatic gallstones, pancreatitis, etc
* Intervention (aspiration or surgical intervention) within three months from baseline
* Treatment with somatostatin analogues within three months from baseline
* Mental illness that interferes with the patient ability to comply with the protocol
* Drug or alcohol abuse within one year from baseline
* Abnormal liver function tests, as determined by blood test (except isolated elevated GGT and AP, which occurs frequently in PLD)
* Clinical diagnosis of pancreatitis
* Diagnosis of diabetes mellitus, as determined by blood test and medical history
* Use of drugs that can interact with lanreotide, such as cyclosporin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01354405
Study Brief:
Protocol Section:
NCT01354405