Kidney FailureDFPPSURVNCT04261205
Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre
An observational study of Kidney Failure, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
A study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Kidney Failure
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 4 Aug 2018to 13 Nov 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 19 to 99 years
- All sexes
- Adult, Older adult
Study population: All patients over 18 years of age who consecutively benefit from plasmapheresis sessions by double cascade filtration system during hospitalization at the University Hospital of Nîmes, within the framework of the usual indications retained in the department for a period of 12 months.
Who may be able to join
- Over 18 years of age I indication for plasmapheresis and hospitalized at Chu de Nimes.
Who cannot join
- Under guardianship or curatorship Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
A study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. As part of this study, the investigators will ask all patients scheduled for this procedure to participate in this observational prospective study without changing usual practices.
Read the detailed description
The objective of the study is to conduct a prospective evaluation of the practice of apheresis by Double Filtration System Cascade system in a university centre in current practice with evaluation of the technical and biological effectiveness as the main objective and clinical and biological tolerance as the secondary objective for all consecutive sessions performed in a university centre over a period of 1 year.
- Conditions
- Kidney Failure
- Keywords
- Chronic hemodialysis
- Medical subject headings
- Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Apheresis by DFPP and biological efficiency
quantification of the purification carried out (volume)
Measured: over a period of one year
Secondary outcomes (3)
Clinical side effects
catheter dysfunction
Measured: within 1 hour of all session
Biological side effects
Bleeding rate
Measured: within 1 hour of all session
variation of Hb, platelet and albumin before and after session
% of Hb, platelet and albumin
Measured: within 1 hour of all session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start4 Aug 2018
- Primary completion17 Oct 2020
- Study completion13 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Moranne, MD, PhD, Principal investigator, CHU Nîmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261205
- Sponsor's protocol ID
- Local/2017/0M-01
- Acronym
- DFPPSURV
- Status last verified
- Oct 2020
- First submitted
- 27 Nov 2019
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre
- ClinicalTrials.gov ID
- NCT04261205
- Acronym / sponsor ID
- DFPPSURV / Local/2017/0M-01
- Conditions
- Kidney Failure
- Keywords
- Chronic hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 4 Aug 2018 (actual)
- Primary completion
- 17 Oct 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 7 Feb 2020 (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.
A study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. As part of this study, the investigators will ask all patients scheduled for this procedure to participate in this observational prospective study without changing usual practices.
Detailed description
The objective of the study is to conduct a prospective evaluation of the practice of apheresis by Double Filtration System Cascade system in a university centre in current practice with evaluation of the technical and biological effectiveness as the main objective and clinical and biological tolerance as the secondary objective for all consecutive sessions performed in a university centre over a period of 1 year.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients over 18 years of age who consecutively benefit from plasmapheresis sessions by double cascade filtration system during hospitalization at the University Hospital of Nîmes, within the framework of the usual indications retained in the department for a period of 12 months.
Key inclusion criteria (1 listed)
- Over 18 years of age I indication for plasmapheresis and hospitalized at Chu de Nimes.
Key exclusion criteria (1 listed)
- Under guardianship or curatorship Refusal to participate
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
Apheresis by DFPP and biological efficiency
Time frame: over a period of one year
quantification of the purification carried out (volume)
3 secondary outcomes
Clinical side effects
Time frame: within 1 hour of all session
Biological side effects
Time frame: within 1 hour of all session
variation of Hb, platelet and albumin before and after session
Time frame: within 1 hour of all session
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 16 Nov 2020.
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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.
Olivier Moranne, MD, PhD principal investigator
CHU Nîmes
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 Kidney Failure, run by Centre Hospitalier Universitaire de Nīmes 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 1 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: finished, as of the sponsor's last update on 16 Nov 2020. 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?
Apheresis by DFPP and biological efficiency (time frame: over a period of one year). 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 16 Nov 2020.