Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency

NCT01377246 | Completed Phase 3

• 2 other identifiers: ALADIN22011-000138-12
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

The general aim of the trial is to assess the efficacy of one year treatment with long-acting somatostatin analogue (Octreotide LAR) compared with placebo in slowing kidney and liver growth rate in patients with ADPKD and moderate/severe renal insufficiency and to assess whether and to which extent this translates into slower renal function decline over 3-year follow-up.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

Somatostatin.; Polycystic kidney disease.; Renal insufficiency.

Outcome Measures

Primary Outcomes (2)

• Total kidney volume (TKV) change (delta TKV) as assessed by spiral computed tomography (spiral CT) scan.

  Short-term (1 year)outcome.

  At 0, 12 and 36 month.

• Rate of GFR decline as assessed by serial measurements of the iohexol plasma clearance.

  Long-term (3 year)outcome.

  At 0, 12, 24 and 36 month.

Secondary Outcomes (4)

• Total renal cyst volume.

  At 0,12 and 36 month.

• Total renal parenchyma volume.

  At 0, 12 and 36 month.

• Total renal intermediate volume.

  At 0,12 and 36 month.

• Total liver and liver cyst volumes.

  At 0, 12 and 36 month.

Study Arms (2)

Saline solution.

PLACEBO COMPARATOR

Other: Saline solution.

Octrotide-LAR

EXPERIMENTAL

Drug: Octreotide-LAR

Interventions

Octreotide-LAR DRUG

40 mg every 28 days (in two intragluteal 20 mg injections) for three years

Octrotide-LAR

Saline solution. OTHER

At the same volume of study drug every 28 days (in two intragluteal injections) for three years.

Saline solution.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Clinical and ultrasound diagnosis of ADPKD
• Estimated GFR between 15 and 40 ml/min/1.73m2 (by the MDRD 4 variable equation)
• Written informed consent

You may not qualify if:

• h Urinary protein excretion rate \>3g (suggestive of a concomitant glomerular disease that could benefit of specific therapy)
• Symptomatic urinary tract lithiasis or obstruction
• Uncontrolled diabetes mellitus (HbA1c \>8%) or hypertension (systolic/diastolic BP \>180/110 mmHg)
• Current urinary tract infection
• Symptomatic 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)

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (6)

Ospedale San giovanni di Dio

Agrigento, AG, Italy

Location

Clinical Research Center fo Rare Diseases Aldo and Cele Daccò

Ranica, Bergamo, 24020, Italy

Location

Hospital "Vito Fazzi"

Lecce, Italy

Location

Hospital "Ospedale Maggiore policlinico, Mangiagalli e Regina elena"

Milan, Italy

Location

University "Federico II"

Naples, Italy

Location

Ospedale Cà Foncello

Treviso, Italy

Location

Related Publications (2)

• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

  PMID: 39356039 DERIVED

• Perico N, Ruggenenti P, Perna A, Caroli A, Trillini M, Sironi S, Pisani A, Riccio E, Imbriaco M, Dugo M, Morana G, Granata A, Figuera M, Gaspari F, Carrara F, Rubis N, Villa A, Gamba S, Prandini S, Cortinovis M, Remuzzi A, Remuzzi G; ALADIN 2 Study Group. Octreotide-LAR in later-stage autosomal dominant polycystic kidney disease (ALADIN 2): A randomized, double-blind, placebo-controlled, multicenter trial. PLoS Med. 2019 Apr 5;16(4):e1002777. doi: 10.1371/journal.pmed.1002777. eCollection 2019 Apr.

  PMID: 30951521 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Polycystic Kidney Diseases; Renal Insufficiency

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 21, 2011
• Study Start: May 1, 2011
• Primary Completion: October 18, 2017
• Study Completion: October 18, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

IT (6)