EFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN II

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012376-27-IT

Enrollment

Registered

2009-11-30

Start date

2009-11-16

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Kidney MedDRA version: 12.1 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant

Interventions

Trade Name: SANDOSTATINA LAR Pharmaceutical Form: Suspension for injection INN or Proposed INN: Octreotide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age > 18 years Clinical and ultrasound diagnosis of ADPKD Estimated GFR between 40-15 ml/min/1.73m2 (by the MDRD 4 variable equation) Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Diabetes Mellitus Other primary or secondary renal diseases. Proteinuria excretion rate >1g/24 hours or abnormal urinalysis suggestive of concomitant glomerular disease Urinary tract lithiasis or obstruction Current urinary tract infection 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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of long acting somatostatin analogue versus placebo on the total kidney volume (TKV) change (delta TKV) assessed by spiral computed tomography (spiral CT) after one year of treatment in patients with ADPKD and moderate/severe renal failure (estimated GFR by MDRD 4 variables: 40-15 ml/min/1.73m2) .;Secondary Objective: To compare, among the two groups, absolute and relative changes in renal and liver volume parameters (at month 0 and 12 and, if appropriate, 36) as well as in functional and biochemical parameters by quarterly clinical visits during the 12 month follow-up.;Primary end point(s): Total kidney volume (TKV) change (delta TKV.	—

Measure

Time frame

Main Objective: To compare the effect of long acting somatostatin analogue versus placebo on the total kidney volume (TKV) change (delta TKV) assessed by spiral computed tomography (spiral CT) after one year of treatment in patients with ADPKD and moderate/severe renal failure (estimated GFR by MDRD 4 variables: 40-15 ml/min/1.73m2) .;Secondary Objective: To compare, among the two groups, absolute and relative changes in renal and liver volume parameters (at month 0 and 12 and, if appropriate, 36) as well as in functional and biochemical parameters by quarterly clinical visits during the 12 month follow-up.;Primary end point(s): Total kidney volume (TKV) change (delta TKV.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026