NCT06193616Active, not recruiting
Outcome of ADPKD With Octreotide LAR
Evaluating Baseline Predictors Including Total Kidney Volume, of Chronic GFR Decline and Other Clinical Outcomes in Outpatients With ADPKD and Stage IV CKD on Chronic Treatment With Octreotide LAR: a Retrospective, Observational Study
Source: ClinicalTrials.gov · Last updated 5 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 14 Dec 2023
- Start date
- 12 Feb 2024
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Diseases
- Polycystic kidney disease
- NCT number
- NCT06193616
What you commit to
- Study type: Observational
- Planned participants: 70
- From 12 Feb 2024 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Legal incapacity or limited legal capacity.
- Contraindications to the prescription of octreotide LAR according to Law n. 648, 23 December 1996.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ASST HPG23 - Unità di Nefrologia Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.