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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT00309283
First received: March 30, 2006
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Drug: Long-acting somatostatin
Other: Saline solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Total renal parenchymal volume [ Time Frame: Basal, 1 and 3 years follow-up ] [ Designated as safety issue: No ]
  • Residual renal volume [ Time Frame: Basal, 1 and 3 years follow-up ] [ Designated as safety issue: No ]
  • Renal parenchymal volume taken up by small cysts, minor of five mmcubic [ Time Frame: Basal, 1 and 3 years follow-up ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: April 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: somatostatin 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).

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  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00309283

Locations
Italy
Hospital "Ospedali Riuniti" Unit of Nephrology and Dialysis
Bergamo, Italy, 24128
Hospital "V. Fazzi" - Unit of neprology and Dialysis
Lecce, Italy
Hospital "Presidio Osp. Maggiore Policlinico"
Milan, Italy
University "Federico II" of Naples
Napoli, Italy
Hospital Cà Foncello
Treviso, Italy
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
Principal Investigator: Norberto Perico, MD Mario Negri Institute for Pharmacological Research
  More Information

No publications provided by Mario Negri Institute for Pharmacological Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT00309283     History of Changes
Other Study ID Numbers: ALADIN, 2005-005552-41
Study First Received: March 30, 2006
Last Updated: April 23, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Urogenital Abnormalities
Congenital Abnormalities
Pharmaceutical Solutions
Somatostatin
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014