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Trial · Interventional

CompletedPhase 3Registry data

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

Short name ALADIN2

NCTNCT01377246 (opens ClinicalTrials.gov in a new tab)Other idALADIN2Other id2011-000138-12
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
100 participants (actual)
Sponsor
Mario Negri Institute for Pharmacological Research · Other
Design
Randomized · Quadruple masking
Countries
1 country

Italy

Start
May 2011
Primary completion
18 Oct 2017
Completion
18 Oct 2017
First posted
21 Jun 2011 (estimated)
Last update posted
10 Jan 2018
Conditions
Autosomal Dominant Polycystic Kidney Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201420162018
  1. Ph 3

    ALADIN2

    NCT01377246

    May 2011 to 18 Oct 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Octreotide-LARDrug
  • Saline solution.Other

Arms2

  • Placebo comparator

    Saline solution.

  • Experimental

    Octrotide-LAR

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · At 0, 12 and 36 month.

    Registry description

    Short-term (1 year)outcome.

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

    Time frame · At 0, 12, 24 and 36 month.

    Registry description

    Long-term (3 year)outcome.

Secondary outcomes(4)

  1. Total renal cyst volume.

    Time frame · At 0,12 and 36 month.

  2. Total renal parenchyma volume.

    Time frame · At 0, 12 and 36 month.

  3. Total renal intermediate volume.

    Time frame · At 0,12 and 36 month.

  4. Total liver and liver cyst volumes.

    Time frame · At 0, 12 and 36 month.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

6 results

Octreotide-LAR in later-stage autosomal dominant polycystic kidney disease (ALADIN 2): A randomized, double-blind, placebo-controlled, multicenter trial.

Perico et al. 2019PLoS medicinecited by 61

PMID 30951521PMC6450618DOI 10.1371/journal.pmed.1002777PUB-30951521

CC BY6 results
Download PDFSee results (6)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedSt 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 24-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)

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