An observational study in Autosomal Dominant Polycystic Kidney and ADPKD, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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Among 29 studies in Polycystic Kidney, Autosomal Dominant with a site in Italy — 5 open to participants now, 9 under way, none of them phase 3. Polycystic Kidney, Autosomal Dominant · Italy.
Among the 29 studies in Polycystic Kidney, Autosomal Dominant with a site in Italy, this one is the 4th largest by planned enrollment of the 11 observational ones that give a count, is one of 2 that started in 2021, is one of 11 observational ones, and was the 25th registered.
185 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 42 are open to participants now.
Browse Polycystic Kidney, Autosomal Dominant studies →5 of the 29 studies in Polycystic Kidney, Autosomal Dominant with a site in Italy are open now. Recruiting first, the newest first:
Calico Life Sciences LLC · Sites in Italy, United States, Australia and 9 more countries
Ages 18–55
Mario Negri Institute for Pharmacological Research · Sites in Italy
Healthy volunteers
Fondazione IRCCS Policlinico San Matteo di Pavia · Sites in Italy
Ages 18–75
Ospedale San Raffaele · Sites in Italy
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 30 Polycystic Kidney, Autosomal Dominant studies recruiting now, 8 (27%) set no upper age limit and 19 (63%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 7 · Phase 3 12
First in 2006; this study’s year is marked. 2 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 180 is above the median of 150 across 45 observational studies indexed under Polycystic Kidney, Autosomal Dominant.
Median enrollment 128 across the 18 interventional studies, 100 across the 11 observational. Of the 18 that completed or were terminated, 9 (50%) have results posted.
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11 of 29 have an industry lead sponsor. The 10 most frequent:
IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 513 studies on the registry; 288 are open to participants now.
IRCCS Azienda Ospedaliero-Universitaria di Bologna has 1 study filed under Polycystic Kidney, Autosomal Dominant — fewer than ten, so there is no comparison to draw.
1 of the studies in Polycystic Kidney, Autosomal Dominant with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07016282Mario Negri Institute for Pharmacological ResearchSimulated and Synthetic Health Data: Improving Clinical Research on Rare Diseases. A Real-World Data Simulation of Autosomal Dominant Polycystic Kidney Disease (ADPKD) Trials. A Retrospective, Observational Study | 2027-06 |
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Among the 29 studies in Polycystic Kidney, Autosomal Dominant with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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 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:
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.
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Exclusion Criteria:
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.
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2021 (actual). Primary completion is estimated for Jun 2025, 51 months after the start.
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Polycystic Kidney, Autosomal Dominant →
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