LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to start in early 2014. An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to 60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30 ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by repeated measures, in the overall population as well as in the two GFR stratus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
159
120 mg, subcutaneously, once every 4 weeks
0,5 ml, subcutaneously, once every 4 weeks
Necker hospital
Paris, France
Glomerular filtration rate (GFR)
Time frame: month 36
Glomerular filtration rate (GFR)
Time frame: month 18
Glomerular filtration rate (GFR) decline
Time frame: month 36
Safety, tolerance
Time frame: month 36
Onset or worsening of hypertension
Time frame: month 18
Onset or worsening of hypertension
Time frame: month 36
Quality of life
SF-36, EQ5D
Time frame: month 0
Quality of life
SF-36, EQ5D
Time frame: month 18
Quality of life
SF-36, EQ5D
Time frame: month 36
Cystic pain
Time frame: month 36
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