Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The DIPAK 1 Study: A Randomised, Controlled Clinical Trial Assessing the Efficacy of Lanreotide to Halt Disease Progression in ADPKD
Brief 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.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sirolimus | Intervention Type: DRUG; Name: Sirolimus; Assigned to Arm(s): 2 | Intervention Type: OTHER; Name: Standard; Assigned to Arm(s): 1
B: Arm Label: standard care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Lanreotide; Type: EXPERIMENTAL; Interventions: Drug: Lanreotide | Intervention Type: DRUG; Name: Lanreotide; Assigned to Arm(s): Lanreotide
C: Arm Label: somatostatin; Type: EXPERIMENTAL; Interventions: Drug: Long-acting somatostatin | Arm Label: Saline solution; Type: PLACEBO_COMPARATOR; Interventions: Other: Saline solution | Intervention Type: DRUG; Name: Long-acting somatostatin; Assigned to Arm(s): somatostatin | Intervention Type: OTHER; Name: Saline solution; Assigned to Arm(s): Saline solution
D: Arm Label: Study A, Arm 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Lisinopril, Drug: Telmisartan, Other: Standard Blood Pressure Control | Arm Label: Study A, Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Lisinopril, Drug: Telmisartan, Other: Low Blood Pressure Control | Arm Label: Study A, Arm 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: Lisinopril, Drug: Placebo, Other: Standard Blood Pressure Control | Arm Label: Study A, Arm 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Lisinopril, Drug: Placebo, Other: Low Blood Pressure Control | Intervention Type: DRUG; Name: Lisinopril; Assigned to Arm(s): Study A, Arm 1, Study A, Arm 2, Study A, Arm 3, Study A, Arm 4 | Intervention Type: DRUG; Name: Telmisartan; Assigned to Arm(s): Study A, Arm 1, Study A, Arm 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Study A, Arm 3, Study A, Arm 4 | Intervention Type: OTHER; Name: Standard Blood Pressure Control; Assigned to Arm(s): Study A, Arm 1, Study A, Arm 3 | Intervention Type: OTHER; Name: Low Blood Pressure Control; Assigned to Arm(s): Study A, Arm 2, Study A, Arm 4

Answer: B