Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01377246
• Date of registration: 20/06/2011
• Prospective Registration: No
• Primary sponsor: Mario Negri Institute for Pharmacological Research
• Public title: Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency ALADIN2
• Scientific title: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL TO ASSESS THE EFFECTS OF LONG-ACTING SOMATOSTATIN (OCTREOTIDE LAR) THERAPY ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE TO SEVERE RENAL INSUFFICIENCY
• Date of first enrolment: May 2011
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01377246
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > 18 years

- Clinical and ultrasound diagnosis of ADPKD

- Estimated GFR between 15 and 40 ml/min/1.73m2 (by the MDRD 4 variable equation)

- Written informed consent

Exclusion Criteria:

- 24-h Urinary protein excretion rate >3g (suggestive of a concomitant glomerular
disease that could benefit of specific therapy)

- Symptomatic urinary tract lithiasis or obstruction

- Uncontrolled diabetes mellitus (HbA1c >8%) or hypertension (systolic/diastolic BP
>180/110 mmHg)

- Current urinary tract infection

- Symptomatic biliary tract lithiasis

- Active cancer

- Psychiatric disorders or any condition that might prevent full comprehension of the
purposes and risks of the study

- Pregnancy, lactation or child bearing potential and ineffective contraception
(estrogen therapy in post menopausal women should not be stopped)



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Autosomal Dominant Polycystic Kidney Disease

Intervention(s)

Drug: Octreotide-LAR

Other: Saline solution.

Primary Outcome(s)

Total kidney volume (TKV) change (delta TKV) as assessed by spiral computed tomography (spiral CT) scan. [Time Frame: At 0, 12 and 36 month.]

Rate of GFR decline as assessed by serial measurements of the iohexol plasma clearance. [Time Frame: At 0, 12, 24 and 36 month.]

Secondary Outcome(s)

Total renal intermediate volume. [Time Frame: At 0,12 and 36 month.]

Total renal parenchyma volume. [Time Frame: At 0, 12 and 36 month.]

Total liver and liver cyst volumes. [Time Frame: At 0, 12 and 36 month.]

Total renal cyst volume. [Time Frame: At 0,12 and 36 month.]

Secondary ID(s)

ALADIN2

2011-000138-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors