Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00309283
• Date of registration: 30/03/2006
• Prospective Registration: Yes
• Primary sponsor: Mario Negri Institute for Pharmacological Research
• Public title: Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study ALADIN
• Scientific title: Effect of a Long-acting Somatostatin on Disease Progression in Nephropathy Due to Autosomal Dominant Polycystic Kidney Disease: a Long-term Three Year Follow up Study
• Date of first enrolment: April 2006
• Target sample size: 78
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00309283
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Italy

Contacts

• Name: Norberto Perico, MD
• Affiliation: Mario Negri Institute for Pharmacological Research

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age>18 years

- Clinical and ultrasound diagnosis of ADPKD

- GFR >40 ml/min/1-73 m2 (estimated by the 4 variable MDRD equation)

- Written informed consent

Exclusion Criteria

- Diabetes

- Overt proteinuria (urinary protein excretion rate >1g/24 hours) or abnormal
urinalysis suggestive of concomitant, clinically significant glomerular disease

- Urinary tract lithiasis, infection or obstruction

- Cancer

- Psychiatric disorders and 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: Both

Health Condition(s) or Problem(s) studied

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Intervention(s)

Drug: Long-acting somatostatin

Other: Saline solution

Primary Outcome(s)

Change over baseline of the total kidney volume at 1 and 3 years follow-up (estimated by gadolinium contrast enhanced and T2-weighted magnetic resonance imaging, MRI). [Time Frame: Basal, 1 and 3 years follow-up]

Secondary Outcome(s)

Absolute and percent change over baseline by MRI analysis will be compared in the two ADPKD groups at baseline, at one and three years follow-up of: [Time Frame: Basal, 1 and 3 years follow-up]

Residual renal volume [Time Frame: Basal, 1 and 3 years follow-up]

Renal parenchymal volume taken up by small cysts, minor of five mmcubic [Time Frame: Basal, 1 and 3 years follow-up]

Total renal parenchymal volume [Time Frame: Basal, 1 and 3 years follow-up]

Secondary ID(s)

2005-005552-41

ALADIN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors