Outcome of ADPKD With Octreotide LAR

NCT06193616 · tracked via the Priya Life Science Italy tracker

Sponsor

Mario Negri Institute for Pharmacological Research

Phase

Observational

Started

2024-02-12

Last updated

2025-09-05

Condition(s) studied

Autosomal Dominant Polycystic Kidney

Investigational drug(s) / intervention(s)

Octreotide →

Octreotide: All consenting patients treated with octreotide LAR according to Determina AIFA n. 1264 del 3 August 2018 and fulfilling the selection criteria will be collected at prespecified time-points according to the routine visits scheduled for these patients and the periodic follow-up visits till dialysis initiation as described in the AIFA indication on GU Serie Generale n.5 del 08-01-2020.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

GFR change over time — change from start (day 0) and month 6,12,18,24,30,36,42,48
Assessed by six-monthly routine iohexol plasma clearance and annual TKV measurements

Trial sites (1)

Facility	City	Region	Status
ASST HPG23 - Unità di Nefrologia	Bergamo	BG

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06193616 on ClinicalTrials.gov ↗ ← All trials in Italy