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

• Register: EUCTR
• Last refreshed on: 12 July 2021
• Main ID: EUCTR2009-012376-27-IT
• Date of registration: 30/11/2009
• Prospective Registration: No
• Primary sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 16/11/2009
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012376-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Italy

Key inclusion & exclusion 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:
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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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-
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

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.

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) .

Primary end point(s): Total kidney volume (TKV) change (delta TKV.

Secondary ID(s)

ALADIN II

Ethics review

Status: Approved
Approval date: 08/10/2009
Contact: