Polycystic Kidney DiseasesCOMPLIKNCT06036992
Study and Management of Cystic Complications in Autosomal Dominant Polycystic Kidney Disease
An observational study of Polycystic Kidney Diseases, run by University Hospital, Brest at 1 site in France.
Trial summary
Autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. While the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycystic Kidney Diseases
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2023to 1 Aug 2027
- 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: Patients with autosomal dominant polycystic kidney disease included in Genkyst who present at least one cystic complication.
Who may be able to join
- Patient with autosomal dominant polycystic kidney disease (APKD) participating in the Genkyst study
- Patient with at least one cystic complication. The cystic complications retained are the following:
- Acute or chronic cyst-related pain requiring analgesic treatments
- Cyst infection
- Intracystic haemorrhage
- Urinary lithiasis
- Functional complaints related to the cystic mass: digestive disorders with eating disorders, undernutrition, diaphragmatic compression phenomena, portal hypertension, umbilical or linea alba hernias, ventrations
- Need for a cystic reduction procedure: puncture, marsupialization, open surgery (including preparation for grafting)
Who cannot join
- Patients who have expressed their opposition to taking part in the study
- Patient under legal protection (guardianship, curatorship, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. While the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications and lithiasis. To date, there is no reliable epidemiological data on the frequency and clinical impact of these complications. Diagnosis of these complications is often complicated, and their management has not been codified. The latest international recommendations (KDIGO) provide only low-level recommendations. For the most complex cases (recurrent cystic infections, resistant pain, mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.), practitioners are often at a loss and management varies greatly from one centre to another.
Read the detailed description
Autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. While the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications and lithiasis. To date, there is no reliable epidemiological data on the frequency and clinical impact of these complications. Diagnosis of these complications is often complicated, and their management has not been codified. The latest international recommendations (KDIGO) provide only low-level recommendations. For the most complex cases (recurrent cystic infections, resistant pain, mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.), practitioners are often at a loss and management varies greatly from one centre to another.
- Conditions
- Polycystic Kidney Diseases
- Medical subject headings
- Polycystic Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To improve knowledge of the epidemiology of cystic complications within the Genkyst network
number of cases of cystic complications per year per complication
Measured: 12 months
Secondary outcomes (3)
Creation of a specific multidisciplinary consultation meeting
Meetings and exchanges between different health professionals: interventional radiologists, surgeons, infectiologists, hepatologists, pain specialists and nephrologists to discuss the best possible management for patients with complex cystic complications.
Measured: 12 months
Creation of an image bank
consulting images to recalculate and improve diagnostic scores
Measured: 12 months
Creation of a group of control patients
the change from baseline in quality of life scores at 1 year.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Oct 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036992
- Sponsor's protocol ID
- 29BRC22.0232 - COMPLIK
- Acronym
- COMPLIK
- Status last verified
- Aug 2024
- First submitted
- 26 Jun 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study and Management of Cystic Complications in Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT06036992
- Acronym / sponsor ID
- COMPLIK / 29BRC22.0232 - COMPLIK
- Conditions
- Polycystic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. While the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications and lithiasis. To date, there is no reliable epidemiological data on the frequency and clinical impact of these complications. Diagnosis of these complications is often complicated, and their management has not been codified. The latest international recommendations (KDIGO) provide only low-level recommendations. For the most complex cases (recurrent cystic infections, resistant pain, mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.), practitioners are often at a loss and management varies greatly from one centre to another.
Detailed description
Autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. While the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications and lithiasis. To date, there is no reliable epidemiological data on the frequency and clinical impact of these complications. Diagnosis of these complications is often complicated, and their management has not been codified. The latest international recommendations (KDIGO) provide only low-level recommendations. For the most complex cases (recurrent cystic infections, resistant pain, mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.), practitioners are often at a loss and management varies greatly from one centre to another.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with autosomal dominant polycystic kidney disease included in Genkyst who present at least one cystic complication.
Key inclusion criteria (8 listed)
- Patient with autosomal dominant polycystic kidney disease (APKD) participating in the Genkyst study
- Patient with at least one cystic complication. The cystic complications retained are the following:
Key exclusion criteria (2 listed)
- Patients who have expressed their opposition to taking part in the study
- Patient under legal protection (guardianship, curatorship, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To improve knowledge of the epidemiology of cystic complications within the Genkyst network
Time frame: 12 months
number of cases of cystic complications per year per complication
3 secondary outcomes
Creation of a specific multidisciplinary consultation meeting
Time frame: 12 months
Creation of an image bank
Time frame: 12 months
Creation of a group of control patients
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Kidney Diseases, run by University Hospital, Brest at 1 site in France.
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 8 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Aug 2024. 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 France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To improve knowledge of the epidemiology of cystic complications within the Genkyst network (time frame: 12 months). 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 9 Aug 2024.