Autosomal Dominant Polycystic Kidney DiseaseGENKYSTNCT02887729
Analysis of Clinical and Molecular Genetic Data Influencing the Evolution and Response to Therapy of ADPKD Patients (Autosomal Dominant Polycystic Kidney Disease)
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by University Hospital, Brest at 26 sites in France.
Trial summary
Genkyst is a regional cohort involving up to nephrologists working in private and public nephrology centers in the West of France. It registers clinical and molecular genetic data of all consenting patients with ADPKD from this area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- How many people
- 4,000 participants
- Where
- 26 sitesFrance
- Study dates
- Jun 2010to Jan 2020
- 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: ADPKD patients followed in Nephrology centers in the West of France
Who may be able to join
- ADPKD patients followed in Nephrology centers in the West of France
- Age >17
Who cannot join
- None
Trial locations and contacts
26 sites in 1 country.
Yannick Le Meur, MD PhD contact
26 sites in 1 country
France26 sites, 26 recruiting
- Recruiting
CHU Angers
Angers, 49933
Jean Francois Augusto, MD PhD, jfaugusto@chu-angers.fr
Jean Francois Augusto, MD PhD
- Recruiting
AUB Brest
Brest, France, 29200
Marie-Paule GUILLODO-HAMELET
- Recruiting
CHU Brest
Brest, 29200
Yannick LE MEUR, MD PhD, yannick.lemeur@chu-brest.fr
Yannick LE MEUR, MD PhD
- Recruiting
Centre Nephrologie et Dialyse d Armorique
Brest, 29283
Katell Goulesque, MD, katell.goulesque@avitum.com
Katell Goulesque, MD
- Recruiting
CH La Roche Sur Yon
La Roche-sur-Yon, 85925
Jean Paul Jaulin, MD, jean-paul.jaulin@chd-vendee.fr
Jean Paul Jaulin, MD
- Recruiting
ECHO dialyse
Le Mans, France, 72016
Guillaume Seret, MD, gseret@echo-sante.com
Guillaume Seret, MD
- Recruiting
CH Le Mans
Le Mans, 72037
Jean Philippe Coindre, MD, jpcoindre@ch-lemans.fr
Jean Philippe Coindre, MD
- Recruiting
AUB Lorient
Lorient, 56100
Didier Legrand, MD
Didier Legrand, MD
- Recruiting
CH Bretagne Sud
Lorient, 56322
Theophile Sawadogo, MD, t.sawadogo@ch-bretagne-sud.fr
Theophile Sawadogo, MD
- Recruiting
AUB Morlaix
Morlaix, 29600
Marin Le Mee, MD, marin.lemee@aub-sante.fr
Marin Le Mee, MD
- Recruiting
CHU Nantes
Nantes, 44093
Maryvonne Hourmand, MD PhD
Maryvonne Hourmand, MD PhD
- Recruiting
CH Niort
Niort, France, 79021
Delphine LABATUT, PH
- Recruiting
CHU Poitiers
Poitiers, 86021
Antoine Thierry, MD PhD, antoine.thierry@chu-poitiers.fr
Antoine Thierry, MD PhD
- Recruiting
CH Centre Bretagne
Pontivy, 56300
Philippe JOUSSET, MD, philippe.jousset@ch-centre-bretagne.fr
Philippe Jousset, MD
- Recruiting
AUB Quimper
Quimper, 29107
Seddik Bernarbia, MD, seddik.benarbia@aub-sante.fr
Seddik Benarbia, MD
- Recruiting
CHI de Cournouaille
Quimper, 29107
Bassem WEHBE, MD, b.wehbe@ch-cornouaille.fr
Bassem Wehbe, MD
- Recruiting
CHU Rennes
Rennes, 35033
Cecile VIGNEAU, MD PhD, cecile.vigneau@chu-rennes.fr
Cecile Vigneau, MD PhD
- Recruiting
ECHO Confluent
Rezé, France, 44402
Angelo Testa, MD, atesta@echo-sante.com
Angelo Testa, MD
- Recruiting
Centre Heliomarin de Roscoff
Roscoff, 29684
Sonia Mzoughi, MD, sonia.mzoughi@perharidy.fr
Sonia Mzoughi, MD
- Recruiting
CH Yves LE FOLL
Saint-Brieuc, 22023
Christophe CHARASSE, MD, christophe.charasse@ch-stbrieuc.fr
Christophe Charasse, MD
- Recruiting
ECHO Centre Ambulatoire
Saint-Herblain, 44821
Corneliu Savoiu, MD
Corneliu Savoiu, MD
- Recruiting
CH de Saint Nazaire
Saint-Nazaire, France, 44606
Dominique Besnier, MD
Dominique Besnier, MD
- Recruiting
CH Saint Malo
St-Malo, France, 35403
Eric Renaudineau, MD
Eric Renaudineau, MD
- Recruiting
CHU Tours
Tours, 37044
Mathias Buchler, MD PhD, buchler@med.univ-tours.fr
Mathias Buchler, MD PhD
- Recruiting
CH Bretagne Atlantique
Vannes, 56017
Regine Perrichot, MD, regine.perrichot@ch-bretagne-atlantique.fr
Regine Perrichot, MD
- Recruiting
ECHO Vannes
Vannes, 56017
Victorio Menoyo, MD, vmenoyo@echo-sante.com
Victorio Menoyo, MD
About this study
Genkyst is a regional cohort involving up to nephrologists working in private and public nephrology centers in the West of France. It registers clinical and molecular genetic data of all consenting patients with ADPKD from this area.
- Keywords
- Polycystic disease
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical description of the patient
Measured: at the inclusion day
Secondary outcomes (1)
Genetic analysis
Measured: at the inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startJun 2010
- Primary completionJan 2020 (estimated)
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 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick Le Meur, MD PhD, Study director, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887729
- Sponsor's protocol ID
- GENKYST
- Acronym
- GENKYST
- Status last verified
- Aug 2016
- First submitted
- 30 Aug 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical and Molecular Genetic Data Influencing the Evolution and Response to Therapy of ADPKD Patients (Autosomal Dominant Polycystic Kidney Disease)
- ClinicalTrials.gov ID
- NCT02887729
- Acronym / sponsor ID
- GENKYST / GENKYST
- Keywords
- Polycystic disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2020 (estimated)
- First posted
- 2 Sep 2016 (estimated)
- 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.
Genkyst is a regional cohort involving up to nephrologists working in private and public nephrology centers in the West of France. It registers clinical and molecular genetic data of all consenting patients with ADPKD from this area.
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
- ADPKD patients followed in Nephrology centers in the West of France
Key inclusion criteria (2 listed)
- ADPKD patients followed in Nephrology centers in the West of France
- Age >17
Key exclusion criteria (1 listed)
- None
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
Clinical description of the patient
Time frame: at the inclusion day
1 secondary outcome
Genetic analysis
Time frame: at the inclusion day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
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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.
Yannick Le Meur, MD PhD contact
Yannick Le Meur, MD PhD study director
University Hospital, Brest
26 sites 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 University Hospital, Brest at 26 sites 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 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: status not confirmed, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick Le Meur, MD PhD (yannick.lemeur@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical description of the patient (time frame: at the inclusion day). 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 2 Sep 2016.