Outcome of ADPKD With Octreotide LAR

NCT06193616 | Active Not Recruiting

• 1 other identifier: ADPKD648
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autosomal Dominant Polycystic Kidney

Keywords

ADPKD; Total kidney volume; Octreotide; Sandostatina LAR

Outcome Measures

Primary Outcomes (1)

• GFR change over time

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

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

Interventions

Octreotide DRUG

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.

Also known as: Octreotide LAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ADPKD who have undergone chronic treatment with octreotide LAR (in accordance with Law N. 648 of December23, 1996), suffering from stage IV CKD and who have been regularly followed, through serial measurements of GFR and TKV and clinical examinations, at the outpatient clinic of the Nephrology Unit at the ASST Papa Giovanni XXIII in Bergamo, Italy.

You may qualify if:

• 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).

You may not qualify if:

• Legal incapacity or limited legal capacity.
• Contraindications to the prescription of octreotide LAR according to Law n. 648, 23 December 1996.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

ASST HPG23 - Unità di Nefrologia

Bergamo, BG, 24100, Italy

Location

Related Publications (3)

• Caroli A, Perico N, Perna A, Antiga L, Brambilla P, Pisani A, Visciano B, Imbriaco M, Messa P, Cerutti R, Dugo M, Cancian L, Buongiorno E, De Pascalis A, Gaspari F, Carrara F, Rubis N, Prandini S, Remuzzi A, Remuzzi G, Ruggenenti P; ALADIN study group. Effect of longacting somatostatin analogue on kidney and cyst growth in autosomal dominant polycystic kidney disease (ALADIN): a randomised, placebo-controlled, multicentre trial. Lancet. 2013 Nov 2;382(9903):1485-95. doi: 10.1016/S0140-6736(13)61407-5. Epub 2013 Aug 21.

  PMID: 23972263 BACKGROUND

• 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 BACKGROUND

• Trillini M, Caroli A, Perico N, Remuzzi A, Brambilla P, Villa G, Perna A, Peracchi T, Rubis N, Martinetti D, Caruso M, Leone VF, Cugini D, Carrara F, Remuzzi G, Ruggenenti P; TOOL Study Group. Effects of Octreotide-Long-Acting Release Added-on Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease: Pilot, Randomized, Placebo-Controlled, Cross-Over Trial. Clin J Am Soc Nephrol. 2023 Feb 1;18(2):223-233. doi: 10.2215/CJN.0000000000000049.

  PMID: 36754009 BACKGROUND

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; 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)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Giuseppe Remuzzi, MD

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 5, 2024
• Study Start: February 12, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)