Polycystic Kidney DiseasesADPKDPDNCT03948113
Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network).
An observational study of Polycystic Kidney Diseases, run by CHU de Reims at 1 site in France.
Trial summary
Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis (PD) in ADPKD patients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Polycystic Kidney Diseases
- What is being tested?
- Dialysis
- How many people
- 17,350 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2000to Dec 2015
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients starting dialysis and included from the French Renal Epidemiology and Information Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF)
Iinclusion criteria :
- Patients starting dialysis
- Patients included from the French Renal Epidemiology and Information Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF) exclusion criteria
- patients without diagnosis of nephropathy
Trial locations and contacts
1 site in 1 country.
About this study
Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis (PD) in ADPKD patients. We aimed to analyze survival and technique failure in ADPKD patients treated with PD.
Read the detailed description
Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis (PD) in ADPKD patients. We aimed to analyze survival and technique failure in ADPKD patients treated with PD. We conducted two retrospective studies on patients starting dialysis between 2000 and 2010, and based on two French registries: The French Renal Epidemiology and Information Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF).
- Conditions
- Polycystic Kidney Diseases
- Being tested
- Dialysis
- Medical subject headings
- Polycystic Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DialysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
the time from the start of dialysis to death
Measured: 15 years
Secondary outcomes (1)
technique survival
the time from the start of dialysis to change of dialysis technique (death and transplantation were considered as competing risk)
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study startFeb 2000
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Kidney DiseasesStudies 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
- 17,350 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
- NCT03948113
- Sponsor's protocol ID
- 2018Ao005
- Acronym
- ADPKDPD
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 13 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sigogne M, Kanagaratnam L, Dupont V, Couchoud C, Verger C, Maheut H, Hazzan M, Halimi JM, Barbe C, Canivet E, Petrache A, Drame M, Rieu P, Toure F. Outcome of autosomal dominant polycystic kidney disease patients on peritoneal dialysis: a national retrospective study based on two French registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network). Nephrol Dial Transplant. 2018 Nov 1;33(11):2020-2026. doi: 10.1093/ndt/gfx364.
PubMed 29361078
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network).
- ClinicalTrials.gov ID
- NCT03948113
- Acronym / sponsor ID
- ADPKDPD / 2018Ao005
- Conditions
- Polycystic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,350 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Feb 2000 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 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.
Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis (PD) in ADPKD patients. We aimed to analyze survival and technique failure in ADPKD patients treated with PD.
Detailed description
Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis (PD) in ADPKD patients. We aimed to analyze survival and technique failure in ADPKD patients treated with PD. We conducted two retrospective studies on patients starting dialysis between 2000 and 2010, and based on two French registries: The French Renal Epidemiology and Information Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients starting dialysis and included from the French Renal Epidemiology and Information Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF)
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 |
|---|---|---|
| Dialysis | Other | – |
Primary outcome
Overall survival
Time frame: 15 years
the time from the start of dialysis to death
1 secondary outcome
technique survival
Time frame: 15 years
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 13 May 2019.
- Background: PubMed 29361078Sigogne M, Kanagaratnam L, Dupont V, Couchoud C, Verger C, Maheut H, Hazzan M, Halimi JM, Barbe C, Canivet E, Petrache A, Drame M, Rieu P, Toure F. Outcome of autosomal dominant polycystic kidney disease patients on peritoneal dialysis: a national retrospective study based on two French registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network). Nephrol Dial Transplant. 2018 Nov 1;33(11):2020-2026. doi: 10.1093/ndt/gfx364.
- Individual participant dataSharing planned: Undecided
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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 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?
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 13 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?
Overall survival (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03948113, which also lists 1 linked publication.
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 13 May 2019.