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Autosomal Dominant Polycystic KidneyNCT06759142

Analysis of Patients With Autosomal Dominant Polycystic Kidney

An observational study of Autosomal Dominant Polycystic Kidney and ADPKD, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main objective of the study is to establish a database of clinical data and genetic data of patients diagnosed with ADPKD, with particular focus on those who have undertaken a specific therapy (Tolvaptan or Octreotide), afferent to the Integrated Renal Genetic Diseases Outpatient Clinic of the U.O. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Autosomal Dominant Polycystic Kidney, ADPKD
How many people
180 participants
Where
1 siteItaly
Study dates
20 Feb 2021to 1 Jun 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients with a definite diagnosis of ADPKD referred to the Integrated Renal Genetic Disease Outpatient Clinic of theTU.O. Nephrology, Dialysis and Transplantation of Policlinico Sant'Orsola-Malpighi directed by Prof La Manna from 01/01/2017 to 01/06/2025.

Who may be able to join

  • 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.

Who cannot join

  • None.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gaetano La Manna, MD contact

+390512144577

gaetano.lamanna@unibo.it

Italy1 site, 1 recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138

    Gaetano La Manna, MD, +0512144577, gaetano.lamanna@unibo.it

    Recruiting

Other trials in Italy

About this study

The main objective of the study is to establish a database of clinical data and genetic data of patients diagnosed with ADPKD, with particular focus on those who have undertaken a specific therapy (Tolvaptan or Octreotide), afferent to the Integrated Renal Genetic Diseases Outpatient Clinic of the U.O. Nephrology, Dialysis and Transplantation of the Sant'Orsola-Malpighi Polyclinic directed by Prof. La Manna. In-depth analysis and comparison on clinical, laboratory and instrumental outcomes will be performed within this population.

A thorough personal and family history will be obtained, and once informed consent is obtained, data will be entered and updated during subsequent outpatient monitoring.

Attention is paid to the clinical course of the disease in relation to genetic variants (genotype-phenotype correlation) and treatments performed by patients, in order to monitor the progression of the disease to end-stage renal failure (ESRD) and the impact that specific therapy has on various parameters identified as indicating such progression. In particular, monitoring of the reduction in renal function, as assessed by creatinine, eGFR, 24-hour proteinuria, and urinary osmolarity values, with attention to comparing developmental trends toward ESDR between patients not receiving therapy and patients on specific therapy, and monitoring of the numerical and/or volumetric increase in renal cysts, as assessed by imaging comparison of the TKV value at the time of diagnosis of polycystic kidney disease and at subsequent re-evaluation, with attention to the extent of progression following the initiation of specific therapy, will be performed.

Read the detailed description

The main objective of the study is to establish a database of clinical data and genetic data of patients diagnosed with ADPKD, with particular focus on those who have undertaken a specific therapy (Tolvaptan or Octreotide), afferent to the Integrated Renal Genetic Diseases Outpatient Clinic of the U.O. Nephrology, Dialysis and Transplantation of the Sant'Orsola-Malpighi Polyclinic directed by Prof. La Manna. In-depth analysis and comparison on clinical, laboratory and instrumental outcomes will be performed within this population.

A thorough personal and family history will be obtained, and once informed consent is obtained, data will be entered and updated during subsequent outpatient monitoring.

Attention is paid to the clinical course of the disease in relation to genetic variants (genotype-phenotype correlation) and treatments performed by patients, in order to monitor the progression of the disease to end-stage renal failure (ESRD) and the impact that specific therapy has on various parameters identified as indicating such progression. In particular, monitoring of the reduction in renal function, as assessed by creatinine, eGFR, 24-hour proteinuria, and urinary osmolarity values, with attention to comparing developmental trends toward ESDR between patients not receiving therapy and patients on specific therapy, and monitoring of the numerical and/or volumetric increase in renal cysts, as assessed by imaging comparison of the TKV value at the time of diagnosis of polycystic kidney disease and at subsequent re-evaluation, with attention to the extent of progression following the initiation of specific therapy, will be performed.

The secondary objectives of the study are:

  1. cardiovascular monitoring, understood as analysis of the pressor profile, valvular and cerebral pathologies: special attention will be paid to the diagnosis and course of hypertension and its therapeutic management, the presence of valvulopathy and its course, the presence of aneurysmal changes in the cerebral circulation and its course
  2. the monitoring of urologic complications associated with polycystic disease, such as stones, urinary tract infections, and episodes of macrohematuria.
  3. the monitoring of other conditions associated with polycystic disease, such as hepatic involvement, considering cystic involvement by imaging and laboratory indices of damage, and presence of reported and/or objective bulking syndrome (presence of abdominal wall hernias)
  4. monitoring of side effects of specific therapy: increased uricemia with possible need for therapeutic adjustment, acute liver damage, quality and severity of symptoms related to water loss with regard to Tolvaptan, quality and severity of gastrointestinal symptoms with regard to Octreotide. In both subgroups of patients on specific treatment, the possible need for momentary or permanent discontinuation of therapy will also be analyzed.
Keywords
ADPKD
Medical subject headings
Polycystic Kidney, Autosomal Dominant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To establish a database of clinical data and genetic data of patients diagnosed with ADPKD

    The main objective of the study is to establish a database of clinical data and genetic data of patients diagnosed with ADPKD, with particular focus on those who have undertaken a specific therapy (Tolvaptan or Octreotide), afferent to the Integrated Renal Genetic Diseases Outpatient Clinic of the U.O. Nephrology, Dialysis and Transplantation of the Sant'Orsola-Malpighi Polyclinic directed by Prof. La Manna. In-depth analysis and comparison on clinical, laboratory and instrumental outcomes will be performed within this population.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start20 Feb 2021
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06759142
Sponsor's protocol ID
ADPKD-TO2020
Status last verified
Dec 2024
First submitted
30 Dec 2024
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Autosomal Dominant Polycystic Kidney and ADPKD, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gaetano La Manna, MD (+390512144577, gaetano.lamanna@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To establish a database of clinical data and genetic data of patients diagnosed with ADPKD (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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