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Trial · Observational

Active, not recruitingPhase not statedRegistry data

Outcome of ADPKD With Octreotide LAR

Short name ADPKD648

NCTNCT06193616 (opens ClinicalTrials.gov in a new tab)Other idADPKD648
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase not stated
Enrollment
70 participants (estimated)
Sponsor
Mario Negri Institute for Pharmacological Research · Other
Design
Not stated
Countries
1 country

Italy

Start
12 Feb 2024
Primary completion
31 Dec 2024
Completion
Dec 2025 (estimated)
First posted
5 Jan 2024
Last update posted
5 Sept 2025
Conditions
Autosomal Dominant Polycystic Kidney

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph –

    ADPKD648

    NCT06193616

    12 Feb 2024 to est. Dec 2025

Registry summary

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

In this observational, retrospective study we will primarily aim at evaluating the independent role of baseline clinical and laboratory parameters, including TKV, in the prediction of long term chronic GFR decline and other clinical outcomes and, secondarily, the relationships between GFR and TKV changes over time, in a cohort of ADPKD patients with Stage IV CKD on chronic treatment with octreotide LAR and routinely monitored with serial GFR, TKV and clinical evaluations, at the outpatient clinic of the Nephrology Unit of the Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.

Interventions

  • OctreotideDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. GFR change over time

    Time frame · change from start (day 0) and month 6,12,18,24,30,36,42,48

    Registry description

    Assessed by six-monthly routine iohexol plasma clearance and annual TKV measurements

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.

A trial that is still running, or that stopped early, may post results later.

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

Studies2

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)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2023

Effects of Octreotide-Long-Acting Release Added-on Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease: Pilot, Randomized, Placebo-Controlled, Cross-Over Trial.

Trillini et al. 2023Clinical journal of the American Society of Nephrology : CJASNcited by 24

PMID 36754009PMC10103320DOI 10.2215/cjn.0000000000000049PUB-36754009

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * ADPKD patients with criteria for the prescription of octreotide LAR according to Law n. 648, 23 December 1996: ≥ 18 year-old; Clinical and instrumental diagnosis of ADPKD; Estimated GFR (MDRD): ≥ 15 ml/min/1.73m2 and \<30 ml/min/1.73m2. * Written informed consent to participate in the observational study and to the use of recorded data for research purposes. * Availability of an adequate (for quantitative volumetric analyses) non-contrast enhanced Computed Tomography (CT) scan acquired before starting octreotide-LAR therapy. * Follow-up of at least six months (eg. up to the first post-treatment GFR evaluation from the start of chronic octreotide LAR treatment). Exclusion Criteria: * Legal incapacity or limited legal capacity. * Contraindications to the prescription of octreotide LAR according to Law n. 648, 23 December 1996.

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