Meijer E, et al. - In this randomized clinical trial, researchers examined the efficacy of somatostatin analog lanreotide for slowing the rate of decline in kidney function in patients with autosomal dominant polycystic kidney disease (ADPKD). Outcomes revealed no slowing of kidney function decline with lanreotide administration in patients with later-stage ADPKD.

Methods

• Researchers performed an open-label randomized clinical trial with blinded end point assessment at 4 nephrology outpatient clinics in the Netherlands; 309 patients with ADPKD were included from July 2012 to March 2015.
• Patients aged 18 to 60 years with an estimated glomerular filtration rate (eGFR) of 30 to 60 mL/min/1.73 m² were eligible for inclusion.
• In August 2017, follow-up of the 2.5-year trial ended.
• They randomly assigned patients to receive either lanreotide (120 mg subcutaneously once every 4 weeks) in addition to standard care (n = 153) or standard care only (target blood pressure <140/90 mm Hg; n = 152).
• Annual change in eGFR assessed as slope through eGFR values during the 2.5-year treatment phase was assessed as the primary outcome.
• Change in eGFR before vs after treatment, incidence of worsening kidney function (start of dialysis or 30% decrease in eGFR), change in total kidney volume and change in quality of life (range: 1 [not bothered] to 5 [extremely bothered]) were included as secondary outcome measures.

Results

• The trial was completed by 261 (85.6%) of 309 randomized patients (mean [SD] age, 48.4 [7.3] years; 53.4% women).
• The lanreotide and the control group had annual rate of eGFR decline of −3.53 vs −3.46 mL/min/1.73 m²per year, respectively (difference, −0.08 [95% CI, −0.71 to 0.56]; P=.81).
• Researchers noted no marked differences for incidence of worsening kidney function (hazard ratio, 0.87 [95% CI, 0.49 to 1.52]; P=.87), change in eGFR (−3.58 vs −3.45; difference, −0.13 mL/min/1.73 m² per year [95% CI, −1.76 to 1.50]; P=.88), and change in quality of life (0.05 vs 0.07; difference, −0.03 units per year [95% CI, −0.13 to 0.08]; P=.67).
• The lanreotide group displayed lower rate of growth in total kidney volume than the control group (4.15% vs 5.56%; difference, −1.33% per year [95% CI, −2.41% to −0.24%]; P=.02).
• The lanreotide vs control group had adverse events including injection site discomfort (32% vs 0.7%), injection site papule (5.9% vs 0%), loose stools (91% vs 6.6%), abdominal discomfort (79% vs 20%), and hepatic cyst infections (5.2% vs 0%).