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

This study has been completed.
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01354405
First received: May 13, 2011
Last updated: July 8, 2014
Last verified: July 2014

May 13, 2011
July 8, 2014
May 2011
June 2014   (final data collection date for primary outcome measure)
Liver volume [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry
Same as current
Complete list of historical versions of study NCT01354405 on ClinicalTrials.gov Archive Site
  • Kidney volume [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in kidney volume between baseline and 24 weeks, as determined by CT volumetry
  • Glomerular filtration rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in GFR between baseline and 24 weeks, as determined by serum and 24 hrs urinary creatinine measurement
  • Urinary tubular damage markers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in urinary tubular damage markers between baseline and 24 weeks
  • Symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in symptoms between baseline and 24 weeks, assessed by GI-questionnaire
  • Blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in blood pressure between baseline and 24 weeks
  • quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in quality of life between baseline and 24 weeks, measured by EuroQoL-questionnaire
  • Adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    All adverse events that occur during 24 weeks of treatment
Same as current
Not Provided
Not Provided
 
Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)
The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease

The aim of this study is to determine the effect of Lanreotide on polycystic liver and kidneys in patients with autosomal dominant polycystic kidney disease.

The aim of this single center observational study is to assess the effect of lanreotide on polycystic liver and kidney. This is achieved by assessing total liver and kidney volume, and several urinary markers that could predict kidney damage or kidney dysfunction, such as GFR, blood pressure, and urinary tubular damage markers and serum biomarker FGF23.

The investigators aim to include 43 patients affected by a polycystic liver due to ADPKD. The duration of the trial will be 28 weeks. The treatment will be 24 weeks and the first screening visit will take place four weeks before start of treatment. Eligible patients will be invited to participate.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples

Non-Probability Sample

ADPKD patients in Radboud University Hospital

Polycystic Liver Disease
Drug: Lanreotide
120 mg every 28 days intramuscular
Other Name: Somatuline
Lanreotide
Intervention: Drug: Lanreotide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01354405
PCLD 10-03
Yes
Radboud University
Radboud University
Ipsen
Principal Investigator: Joost PH Drenth, MD, PhD Radboud University Hospital
Radboud University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP