Study of Lanreotide to Treat Polycystic Kidney Disease
Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive cyst
formation in both kidneys, in most patients leading to end stage renal disease. It is the
most common hereditary renal disease with a prevalence of approximately 1 in 1,000 persons.
The majority of patients also have progressive cyst formation in the liver, leading to pain,
gastrointestinal discomfort and sometimes the need for liver transplantation. At present
there is no proven therapeutic intervention to slow the rate of disease progression in human
ADPKD. The development of renoprotective treatments that are well tolerated, is therefore of
major importance.
In this respect, somatostatin analogues are promising for especially polycystic liver
disease, but also for the renal phenotype. However, the studies that have been performed thus
far with these agents, were underpowered and of too short duration to reach a definitive
conclusion on the potential reno- and hepatoprotective efficacy of somatostatin analogues.
Therefore, the present study is designed as a randomised clinical trial with sufficient
duration of follow-up to investigate whether the somatostatin analogue Lanreotide slows
progression of polycystic kidney and liver disease in ADPKD-patients.
To this end, 300 ADPKD patients, aged 18-60years, with an eGFR 30-60 ml/min/1.73 m2) will be
randomized 1:1 to standard care or monthly subcutaneous lanreotide injections on top off
standard care. These 300 subjects will go through 15 study visits in 3 years and 1 follow up
visit. During these visits, questionnaires will be filled in, physical examinations will be
performed, blood will be drawn and urine collected. After study completion, rate of renal
function decline in lanreotide treated subjects will be compared to that of subject who
received standard care.
Phase:
Phase 3
Details
Lead Sponsor:
University Medical Center Groningen
Collaborators:
Erasmus Medical Center Leiden University Medical Center Radboud University