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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01354405
Date of registration: 13/05/2011
Prospective Registration: No
Primary sponsor: Radboud University
Public title: Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE) RESOLVE
Scientific title: The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease
Date of first enrolment: May 2011
Target sample size: 43
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01354405
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Netherlands
Contacts
Name:     Joost PH Drenth, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Radboud University Hospital
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Polycystic Liver Disease
Intervention(s)
Drug: Lanreotide
Primary Outcome(s)
Liver volume [Time Frame: 24 weeks]
Secondary Outcome(s)
Adverse events [Time Frame: 24 weeks]
Glomerular filtration rate [Time Frame: 24 weeks]
quality of life [Time Frame: 24 weeks]
Urinary tubular damage markers [Time Frame: 24 weeks]
Kidney volume [Time Frame: 24 weeks]
Blood pressure [Time Frame: 24 weeks]
Symptoms [Time Frame: 24 weeks]
Secondary ID(s)
PCLD 10-03
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ipsen
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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