Meijer E, et al. - In patients with later-stage autosomal dominant polycystic kidney disease (ADPKD), researchers assessed the renal impacts of the somatostatin analogue lanreotide. The follow-up was performed for 2.5 years, during which no slowing of decline in kidney function was observed in association with treatment with lanreotide vs standard care. Overall, the use of lanreotide for treatment of later-stage ADPKD was not supported.

Methods

• In this open-label randomized clinical trial with blinded end point assessment, researchers examined 309 patients with ADPKD from July 2012 to March 2015 at four nephrology outpatient clinics in the Netherlands.
• Patients with 18 to 60 years of age and having an estimated glomerular filtration rate (eGFR) of 30 to 60 mL/min/1.73 m² were considered eligible.
• Participants were followed-up till August 2017, meaning this trial ran for 2.5-year.
• 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) was randomly administered to patients.
• Annual change in eGFR, evaluated as slope through eGFR values during the 2.5-year treatment phase was 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 all assessed as secondary outcomes.

Results

• Randomization involved 309 patients (mean [SD] age, 48.4 [7.3] years; 53.4% women), of whom, 261 (85.6%) completed the trial.
• According to findings, −3.53 vs −3.46 mL/min/1.73 m²per year (difference, −0.08; [95% CI, −0.71 to 0.56]; P=.81) was the estimated annual rate of eGFR decline for the lanreotide vs the control group.
• In terms of 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), no significant differences were observed.
• The lanreotide group vs the control group demonstrated lower rate of growth in total kidney volume (4.15% vs 5.56%; difference, −1.33% per year [95% CI, −2.41% to −0.24%]; P=.02).
• 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%) were documented as adverse events seen in the lanreotide vs control group.