Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)

• 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
• 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)

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]

Adverse events [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