Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01354405 |
Date of registration:
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13/05/2011 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)
RESOLVE |
Scientific title:
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The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease |
Date of first enrolment:
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May 2011 |
Target sample size:
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43 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01354405 |
Study type:
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Observational |
Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Joost PH Drenth, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Radboud University Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Polycystic Liver Disease
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Intervention(s)
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Drug: Lanreotide
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Primary Outcome(s)
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Liver volume
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Adverse events
[Time Frame: 24 weeks]
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Glomerular filtration rate
[Time Frame: 24 weeks]
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quality of life
[Time Frame: 24 weeks]
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Urinary tubular damage markers
[Time Frame: 24 weeks]
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Kidney volume
[Time Frame: 24 weeks]
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Blood pressure
[Time Frame: 24 weeks]
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Symptoms
[Time Frame: 24 weeks]
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Secondary ID(s)
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PCLD 10-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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