Autosomal Dominant Polycystic Kidney DiseasePDP-ADPKDNCT03970018
ADPKD and Peritoneal Dialysis: How Anticipate Peritoneal Pressure?
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by CHU de Reims at 1 site in France.
Trial summary
Autosomal dominant polycystic kidney disease (ADPKD) is first genetic kidney disease and fourth etiology of end stage renal disease in the world. Peritoneal dialysis is underuse in this population. Indeed in this pathology, behind big kidneys and big liver, a hyper pressure is feared with technical failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- What is being tested?
- Intra-peritoneal pressure
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Autosomal dominant polycystic kidney disease (ADPKD) patients starting peritoneal dialysis for end stage renal failure
Who may be able to join
- Major ADPKD patients starting peritoneal dialysis for end stage renal disease between 2010 January 1st and 2015 December 31
- Must have an abdominal tomodensitometry in 2 years around start (between 1 year before and 1 year after)
- Must have an intraperitoneal pressure measurement in the first year of peritoneal dialysis.
- Major ADPKD patients starting peritoneal dialysis for end stage renal disease between 2015 January 1st and 2017 December 31
- Non-inclusion criteria:
- Lack of tomodensitometry or intraperitoneal pressure.
- History of nephrectomy or arterioembolism
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ADPKD Patients and Peritoneal Dialysis: Creation and Validation of Predictive Score for Peritoneal Pressure
Autosomal dominant polycystic kidney disease (ADPKD) is first genetic kidney disease and fourth etiology of end stage renal disease in the world. Peritoneal dialysis is underuse in this population. Indeed in this pathology, behind big kidneys and big liver, a hyper pressure is feared with technical failure. The lack of abdominal space could generate increase of peritoneal pressure. Hyper pressure is already known to be a risk factor of technical failure and over mortality in peritoneal dialysis patients (all nephropathies included). It depends on body mass index and body surface modulating injected volume for each patient. Anticipate peritoneal pressure in this population ADPKD could be an important information for distinguish those who can use peritoneal dialysis without fear and those at risk of technical failure.
The primary objective is to create and validate prediction score for intra-peritoneal pressure, in peritoneal dialysis for ADPKD patients thanks to clinical and radiological values.
Read more
The secondary objectives are to study the association between intra-peritoneal pressure and patient's outcome (global survival and technical survival).
Retrospective, multicentric, national, cohort study will be performed. For the first step (score creation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2010 and 31/12/2015 with tomodensitometry between one year before beginning and one year after were included.
For the second step (score validation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2016 and 31/12/2017 with tomodensitometry between one year before beginning and one year after were included.
Read the detailed description
Autosomal dominant polycystic kidney disease (ADPKD) is first genetic kidney disease and fourth etiology of end stage renal disease in the world. Peritoneal dialysis is underuse in this population. Indeed in this pathology, behind big kidneys and big liver, a hyper pressure is feared with technical failure. The lack of abdominal space could generate increase of peritoneal pressure. Hyper pressure is already known to be a risk factor of technical failure and over mortality in peritoneal dialysis patients (all nephropathies included). It depends on body mass index and body surface modulating injected volume for each patient. Anticipate peritoneal pressure in this population ADPKD could be an important information for distinguish those who can use peritoneal dialysis without fear and those at risk of technical failure.
The primary objective is to create and validate prediction score for intra-peritoneal pressure, in peritoneal dialysis for ADPKD patients thanks to clinical and radiological values.
The secondary objectives are to study the association between intra-peritoneal pressure and patient's outcome (global survival and technical survival).
Retrospective, multicentric, national, cohort study will be performed. For the first step (score creation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2010 and 31/12/2015 with tomodensitometry between one year before beginning and one year after will be included.
For the second step (score validation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2016 and 31/12/2017 with tomodensitometry between one year before beginning and one year after will be included.
Data regarding organ volume and clinical data wich can influence pressure and patient's outcome (global survival and technical survival) will be recorded.
A bivariate analysis will be performed to study the association between intra-peritoneal pressure and clinical data. A multivariate analysis by multiple linear regressions will be performed to create the score. Survival analysis by log rank test and cox regression model will be performed for global survival and technical survival.
- Being tested
- Intra-peritoneal pressure
- Keywords
- Autosomal dominant polycystic kidney disease, peritoneal dialysis, peritoneal pressure
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-peritoneal pressureOther
Measurement of intra-peritoneal pressure
| Study group | Role | What they receive |
|---|---|---|
| Autosomal dominant polycystic kidney disease | Autosomal dominant polycystic kidney disease (ADPKD) patients starting peritoneal dialysis for end stage renal failure will be included in this study. Receives: Other: Intra-peritoneal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a predictive score of intra-peritoneal pressure
Data regarding organ volume and clinical data wich can influence intra-peritoneal pressure will be recorded. A bivariate analysis will be performed to study the association between intra-peritoneal pressure and clinical data. A multivariate analysis by multiple linear regressions will be performed.
Measured: Day 0
Validation of a predictive score of intraperitoneal pressure
Measurment and calculation of intraperitoneal pressure
Measured: Day 0
Secondary outcomes (2)
Global survival
Data regarding global survival will be recorded 12 months after the beginning of peritoneal dialysis.
Measured: 12 months
Technical survival
Data regarding technical survival will be recorded 12 months after the beginning of peritoneal dialysis.
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 posted31 May 2019
- Study start1 Dec 2017
- Primary completion1 Jul 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Retrospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970018
- Sponsor's protocol ID
- PA18042
- Acronym
- PDP-ADPKD
- Status last verified
- May 2019
- First submitted
- 27 Mar 2018
- Last updated
- 31 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADPKD Patients and Peritoneal Dialysis: Creation and Validation of Predictive Score for Peritoneal Pressure
- ClinicalTrials.gov ID
- NCT03970018
- Acronym / sponsor ID
- PDP-ADPKD / PA18042
- Keywords
- Autosomal dominant polycystic kidney disease, peritoneal dialysis, peritoneal pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 31 May 2019 (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 (ADPKD) is first genetic kidney disease and fourth etiology of end stage renal disease in the world. Peritoneal dialysis is underuse in this population. Indeed in this pathology, behind big kidneys and big liver, a hyper pressure is feared with technical failure. The lack of abdominal space could generate increase of peritoneal pressure. Hyper pressure is already known to be a risk factor of technical failure and over mortality in peritoneal dialysis patients (all nephropathies included). It depends on body mass index and body surface modulating injected volume for each patient. Anticipate peritoneal pressure in this population ADPKD could be an important information for distinguish those who can use peritoneal dialysis without fear and those at risk of technical failure.
The primary objective is to create and validate prediction score for intra-peritoneal pressure, in peritoneal dialysis for ADPKD patients thanks to clinical and radiological values.
The secondary objectives are to study the association between intra-peritoneal pressure and patient's outcome (global survival and technical survival).
Retrospective, multicentric, national, cohort study will be performed. For the first step (score creation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2010 and 31/12/2015 with tomodensitometry between one year before beginning and one year after were included.
For the second step (score validation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2016 and 31/12/2017 with tomodensitometry between one year before beginning and one year after were included.
Detailed description
Autosomal dominant polycystic kidney disease (ADPKD) is first genetic kidney disease and fourth etiology of end stage renal disease in the world. Peritoneal dialysis is underuse in this population. Indeed in this pathology, behind big kidneys and big liver, a hyper pressure is feared with technical failure. The lack of abdominal space could generate increase of peritoneal pressure. Hyper pressure is already known to be a risk factor of technical failure and over mortality in peritoneal dialysis patients (all nephropathies included). It depends on body mass index and body surface modulating injected volume for each patient. Anticipate peritoneal pressure in this population ADPKD could be an important information for distinguish those who can use peritoneal dialysis without fear and those at risk of technical failure.
The primary objective is to create and validate prediction score for intra-peritoneal pressure, in peritoneal dialysis for ADPKD patients thanks to clinical and radiological values.
The secondary objectives are to study the association between intra-peritoneal pressure and patient's outcome (global survival and technical survival).
Retrospective, multicentric, national, cohort study will be performed. For the first step (score creation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2010 and 31/12/2015 with tomodensitometry between one year before beginning and one year after will be included.
For the second step (score validation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2016 and 31/12/2017 with tomodensitometry between one year before beginning and one year after will be included.
Data regarding organ volume and clinical data wich can influence pressure and patient's outcome (global survival and technical survival) will be recorded.
A bivariate analysis will be performed to study the association between intra-peritoneal pressure and clinical data. A multivariate analysis by multiple linear regressions will be performed to create the score. Survival analysis by log rank test and cox regression model will be performed for global survival and technical survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autosomal dominant polycystic kidney disease | – | Other: Intra-peritoneal pressureAutosomal dominant polycystic kidney disease (ADPKD) patients starting peritoneal dialysis for end stage renal failure will be included in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Autosomal dominant polycystic kidney disease (ADPKD) patients starting peritoneal dialysis for end stage renal failure
Key inclusion criteria (7 listed)
- Major ADPKD patients starting peritoneal dialysis for end stage renal disease between 2010 January 1st and 2015 December 31
- Must have an abdominal tomodensitometry in 2 years around start (between 1 year before and 1 year after)
- Must have an intraperitoneal pressure measurement in the first year of peritoneal dialysis.
- Major ADPKD patients starting peritoneal dialysis for end stage renal disease between 2015 January 1st and 2017 December 31
- Lack of tomodensitometry or intraperitoneal pressure.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-peritoneal pressureMeasurement of intra-peritoneal pressure | Other | Autosomal dominant polycystic kidney disease |
Primary outcome
Creation of a predictive score of intra-peritoneal pressure
Time frame: Day 0
Data regarding organ volume and clinical data wich can influence intra-peritoneal pressure will be recorded. A bivariate analysis will be performed to study the association between intra-peritoneal pressure and clinical data. A multivariate analysis by multiple linear regressions will be performed.
Validation of a predictive score of intraperitoneal pressure
Time frame: Day 0
Measurment and calculation of intraperitoneal pressure
2 secondary outcomes
Global survival
Time frame: 12 months
Technical survival
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
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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 Autosomal Dominant Polycystic Kidney Disease, run by CHU de Reims 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 7 inclusion and 0 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: finished, as of the sponsor's last update on 31 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Creation of a predictive score of intra-peritoneal pressure (time frame: Day 0). The study lists 2 primary outcomes in all. 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 31 May 2019.