Database analysis of patients with Autosomal Dominant Polycystic Kidney Disease
Analysis of Patients With Autosomal Dominant Polycystic Kidney
This study is trying to gather and track health information from people with Autosomal Dominant Polycystic Kidney Disease to see how different treatments affect their kidney function and cyst growth over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06759142 on ClinicalTrials.gov |
What this trial studies
This study aims to create a comprehensive database of clinical and genetic data for patients diagnosed with Autosomal Dominant Polycystic Kidney Disease (ADPKD), particularly those who have received treatments like Tolvaptan or Octreotide. It will involve collecting detailed personal and family histories, and monitoring clinical outcomes over time. The research will focus on understanding the relationship between genetic variants and disease progression, specifically tracking the impact of therapies on renal function and cyst growth. Data will be continuously updated during outpatient visits to ensure accurate monitoring of disease progression.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with ADPKD, particularly those who have undergone specific therapies.
Not a fit: Patients without a diagnosis of ADPKD or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of ADPKD and improve treatment strategies for patients.
How similar studies have performed: While similar studies have been conducted, this specific approach focusing on genotype-phenotype correlation in ADPKD patients receiving targeted therapies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age-matched subjects with a diagnosis of ADPKD defined on the basis of the Unified Criteria of Pei. Diagnosis in subjects with a positive family history is based on age-differentiated ultrasound criteria. The presence of a "total of 3 or more cysts" in subjects aged 18-39 years and "2 or more cysts in each kidney" in at-risk subjects aged 40-59 years are sufficient to make the diagnosis of ADPKD.In the absence of family history, the presence of more than 10 cysts per kidney on ultrasound is typically considered diagnostic. Where the picture appears unclear, and particularly where the diagnosis has a major fallout (related to family planning, renal donation, initiation of specific drug treatment), genetic confirmation is strongly recommended. * Obtaining Informed Written Consent. Exclusion Criteria: * None.
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Gaetano La Manna, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Gaetano La Manna, MD
- Email: gaetano.lamanna@unibo.it
- Phone: +390512144577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.