Actively Recruiting

Age: 18Years +
All Genders
ID06759142

Analysis of Patients With Autosomal Dominant Polycystic Kidney Disease Focusing on Clinical and Genetic Data

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-06

180

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting clinical and genetic data from patients diagnosed with Autosomal Dominant Polycystic Kidney Disease (ADPKD), focusing especially on those receiving specific treatments such as Tolvaptan or Octreotide. The study aims to analyze and compare clinical, laboratory, and imaging outcomes to better understand disease progression and treatment effects, particularly related to kidney function and cyst development. This observational research is conducted at the Integrated Renal Genetic Diseases Outpatient Clinic of the Sant'Orsola-Malpighi Polyclinic under the direction of Prof. La Manna. Participants will have their personal and family medical histories taken, and data will be gathered and updated through outpatient visits over time. The study pays close attention to the relationship between genetic variants and clinical outcomes, tracking kidney function markers like creatinine, eGFR, proteinuria, and urinary osmolarity. Imaging will be used to monitor changes in kidney cyst size and number, comparing patients on specific therapies versus those not receiving these treatments. Secondary objectives include monitoring cardiovascular health, urologic complications, liver involvement, and side effects related to the specific therapies, such as liver damage or symptoms from water loss or gastrointestinal issues. During the study, patients will undergo regular evaluations including clinical exams, laboratory tests, and imaging to assess kidney disease progression and treatment impact. Researchers will continuously update the database with these findings, focusing on kidney function decline and cyst growth as primary outcomes. Additional monitoring of blood pressure, heart and brain vessel conditions, urinary tract issues, and liver cysts will provide a comprehensive picture of disease effects. The study plans to follow participants for up to five years to build a detailed and ongoing data resource.

CONDITIONS

Brief Title

Analysis of Patients With Autosomal Dominant Polycystic Kidney

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD) based on Unified Criteria of Pei
  • Diagnosis using age-differentiated ultrasound criteria if positive family history
  • Genetic confirmation recommended if diagnosis is unclear or impacts treatment/family planning
  • Ability to provide informed written consent
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored over time to collect clinical, genetic, laboratory, and imaging data related to Autosomal Dominant Polycystic Kidney Disease, including disease progression, treatment effects, and associated complications.

Regular outpatient monitoring visits over the study period

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

G

Gaetano La Manna, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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