Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study (ALADIN)
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal disease, responsible for 8% to 10% of the cases of end stage renal disease (ESRD) in Western countries. At comparable levels of blood pressure control and proteinuria, patients with ADPKD have faster decline in glomerular filtration rate than those with other renal diseases and do not seem to benefit to the same extent of ACE inhibitor therapy. A reasonable explanation for the above findings is that in ADPKD progression is largely dependent on the development and growth of cysts and secondary disruption of normal tissue. Thus, renoprotective interventions in ADPKD - in addition to achieve maximal reduction of arterial blood pressure and proteinuria and to limit the effects of additional potential promoters of disease progression such as dyslipidemia, chronic hyperglycemia or smoking - should also be specifically aimed to correct the dysregulation of epithelial cell growth, secretion, and matrix interactions characteristic of the disease.
Evidence that specific receptors for somatostatin are present in the kidney tissue, arises the possibility that somatostatin treatment in patients with ADPKD might inhibit fluid formation and eventually induce the shrinking of renal cysts.To evaluate the tolerability and the safety of long-acting somatostatin in ADPKD patients, a prospective cross-over controlled study has been recently performed. This pilot study demonstrated the safety of six month treatment of long-acting somatostatin in patients with ADPKD. Moreover, the percent increase of total kidney volume was significantly lower in patients on somatostatin than in placebo. Overall, these findings provide the basis for designing a long-term study in ADPKD patients aimed to document the efficacy of the somatostatin treatment in preventing further increase or even reducing the total kidney volume and the renal volume taken up by small cysts, eventually halting kidney disease progression.
|Autosomal Dominant Polycystic Kidney Disease (ADPKD)||Drug: Long-acting somatostatin Other: Saline solution||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official 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|
- 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 ]
- 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 ]
- Total renal parenchymal volume [ 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 ]
|Study Start Date:||April 2006|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Drug: Long-acting somatostatin
Patients randomized to treatment will be given intramuscularly long-acting somatostatin (Sandostatin-LAR, Novartis, Basel) at the dose of 40 mg every 28 days (in two intragluteal 20 mg injections).
|Placebo Comparator: Saline solution||
Other: Saline solution
Patients randomized to placebo will be given intramuscularly the same volume of solvent used to dissolve somatostatin every 28 days (in two intragluteal injections).
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309283
|Hospital "Ospedali Riuniti" Unit of Nephrology and Dialysis|
|Bergamo, Italy, 24128|
|Hospital "V. Fazzi" - Unit of neprology and Dialysis|
|Hospital "Presidio Osp. Maggiore Policlinico"|
|University "Federico II" of Naples|
|Hospital Cà Foncello|
|Principal Investigator:||Norberto Perico, MD||Mario Negri Institute for Pharmacological Research|