End Stage Renal DiseaseHDQ200NCT01845012
Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis
A study testing Daily hemodialysis at low dialysate flow in people with End Stage Renal Disease, run by Association Pour L'utilisation Rein Artificiel Région Lyonnaise at 13 sites in 2 countries.
Trial summary
HDQ 200 is an interventional multicenter study. This is a before-and-after design in which the patient is his own control. The main objective of the study is to determine the percentage of success of a procedure of daily hemodialysis at low dialysate flow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Daily hemodialysis at low dialysate flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jul 2012to Jan 2015
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Patients who give voluntary signed informed consent
- Patients affiliated with the French universal health care system or similar
- For women of childbearing potential: serum or urine negative pregnancy test
- Patients treated with conventional hemodialysis (3 times 4h to 5h per week at at least a dialysate flow rate of 500 ml/min) for at least 3 months and clinically stable (investigator assessment)
- Bipuncture patients (or with double lumen central venous catheter) with stable vascular access and easy to puncture
- Patients willing to be treated with daily hemodialysis at low dialysate flow during the study period (6 times 2h to 2h30 per week at a dialysate flow rate of 200 ml/min in order that the total duration of weekly dialysis is equivalent to the duration of weekly dialysis during the last 3 months of conventional hemodialysis)
Who cannot join
- Pregnant women or women who could become pregnant during the study (planned pregnancy within 3 months)
- Patients not affiliated with the French universal health care system
- Minor patients
- Patients who are protected adults according to the terms of the law (French public health laws).
- Refusal to give consent
- Patients simultaneously participating in another trial that may interfere with the study results
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
France12 sites
ECHO Angers
Angers, 49055
CTMR Saint Augustin
Bordeaux, 33000
CHPC
Cherbourg, 50102
CHU Grenoble
Grenoble, 38043
ANIDER
Le Petit-Quevilly, 76143
AURAL
Lyon, 69008
Hospices Civils de Lyon - Hôpital Edouard Herriot
Lyon, 69437
AGDUC Meylan
Meylan, 38240
AURA - Paris
Paris, 75015
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
ECHO Nantes
Rezé, 44402
Centre Hospitalier de Vichy
Vichy, 03201
About this study
HDQ 200 is an interventional multicenter study. This is a before-and-after design in which the patient is his own control. The main objective of the study is to determine the percentage of success of a procedure of daily hemodialysis at low dialysate flow. All patients treated with conventional hemodialysis, for at least 3 months and clinically stable, can be included in the study. Their 3 months data prior to inclusion is collected retrospectively. These 3 months of conventional hemodialysis are the reference period. Patients are then treated with daily hemodialysis at low dialysate flow for 3 months. During this 3 months period, the same data as during the period of conventional hemodialysis are collected prospectively.
- Conditions
- End Stage Renal Disease
- Being tested
- Daily hemodialysis at low dialysate flow
- Keywords
- Short daily hemodialysis, Low dialysate flow, End stage renal disease
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily hemodialysis at low dialysate flowOther
Daily hemodialysis at low dialysate flow during 3 months: 6 times 2h to 2h30 per week at a dialysate flow rate of 200 ml/min in order that the total duration of weekly dialysis is equivalent to the duration of weekly dialysis during the last 3 months of conventional hemodialysis. Other parameters of dialysis (dialysate, dialysis machine, generator, blood flow, anticoagulation) are the same as the reference period of conventional hemodialysis.
| Study group | Role | What they receive |
|---|---|---|
| Daily hemodialysis at low dialysate flow | Experimental | Not described Receives: Other: Daily hemodialysis at low dialysate flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients for whom the period of daily hemodialysis at low dialysate flow will be a success.
Definition of success: if during the period of daily hemodialysis at low dialysate flow, the patient maintains the absolute value of their pre-dialysis serum creatinine (mid-week dialysis) below the upper limit of the confidence interval established during the 3 months prior to inclusion on 7 values: measurements every 2 weeks for 3 months (retrospective data) and inclusion measurement included (Day 0).
Daily hemodialysis at low dialysate flow will be considered as a failure if pre-dialysis serum creatinine values exceed twice successively the upper limit of the confidence interval established for the patient.
Measured: Every 2 weeks during 3 months.
Secondary outcomes (17)
Number of patients who stopped the daily hemodialysis at low dialysate flow (patient or investigator's decision).
Measured: 3 months.
Number of patients who maintained a satisfactory clinical condition (investigator assessment) during the period of daily hemodialysis at low dialysate flow.
Measured: 3 months.
Evaluation of weight.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks.
Measured: During 3 months (retrospectively and prospectively).
Evaluation of blood pressure.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks.
Measured: During 3 months (retrospectively and prospectively).
Evaluation of heart rate.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks.
Measured: During 3 months (retrospectively and prospectively).
Evaluation of body mass index.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks.
Measured: During 3 months (retrospectively and prospectively).
Evaluation of metabolic parameters.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks.
Measured: During 3 months (retrospectively and prospectively).
Evaluation of hematological parameters.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks.
Measured: During 3 months (retrospectively and prospectively).
Evaluation of inflammation parameters.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Detail of time frame during 3 months (retrospectively and prospectively): monthly.
Measured: During 3 months (retrospectively and prospectively).
Evaluation of nutrition parameters.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Detail of time frame during 3 months (retrospectively and prospectively): monthly.
Measured: During 3 months (retrospectively and prospectively).
Evaluation of iron parameters.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Detail of time frame during 3 months (retrospectively and prospectively): monthly.
Measured: During 3 months (retrospectively and prospectively).
Change in hormones.
Measurement at inclusion represent the retrospective period of 3 months in conventional hemodialysis. Measurement at 3 months represent the prospective period of 3 months in daily hemodialysis at low dialysate flow.
Measured: At inclusion and at 3 months.
Composite measurement of treatments.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Detail of time frame during 3 months (retrospectively and prospectively): at each hemodialysis.
A listing of all the therapeutics changes made between the two dialysis periods will be provided (e.g. dose of erythropoietin, phosphate binders, antihypertensive drugs, other treatments)
Measured: During 3 months (retrospectively and prospectively).
Composite measurement of technical dialysis parameters.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks.
A listing of all the technical dialysis changes made between the two dialysis periods will be provided (e.g. urea clearance of the dialysis machine, effective duration of dialysis, ultrafiltration time rate and per dialysis, type of access, blood flow, dialysate flow rate, dialysate composition and anticoagulation method).
Measured: During 3 months (retrospectively and prospectively).
List of symptoms and incidents between two hemodialysis, evaluation of hemodialysis tolerance, clinical assessment of the vascular access and possible local complications.
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Measured: At each hemodialysis during 3 months (retrospectively and prospectively).
Change in quality of life.
Measurement at inclusion represent the retrospective period of 3 months in conventional hemodialysis. Measurement at 3 months represent the prospective period of 3 months in daily hemodialysis at low dialysate flow.
Measured: At inclusion and at 3 months.
Change in pain.
Measurement at inclusion represent the retrospective period of 3 months in conventional hemodialysis. Measurement at 3 months represent the prospective period of 3 months in daily hemodialysis at low dialysate flow.
Measured: At inclusion and at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJul 2012
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Study has been prematurely halted because of failure of patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Pour L'utilisation Rein Artificiel Région Lyonnaise
- Sponsor type
- University, hospital or other
- Collaborators
- Association Nationale pour la promotion de la Dialyse Quotidienne (ANDIQ, France)
- Responsible party
- Sponsor
- Investigators
- Maurice Laville, MD, PHD, Principal investigator, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service de Néphrologie Bâtiment 3C, 3ème étage, Chemin du grand Revoyet 69495 PIERRE-BENITE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845012
- Sponsor's protocol ID
- 2012-A00307-36
- Acronym
- HDQ200
- Status last verified
- Mar 2017
- First submitted
- 11 Apr 2013
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis
- ClinicalTrials.gov ID
- NCT01845012
- Acronym / sponsor ID
- HDQ200 / 2012-A00307-36
- Conditions
- End Stage Renal Disease
- Keywords
- Short daily hemodialysis, Low dialysate flow, End stage renal disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been prematurely halted because of failure of patient recruitment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Association Pour L'utilisation Rein Artificiel Région LyonnaiseUniversity, hospital or other
- Collaborators
- Association Nationale pour la promotion de la Dialyse Quotidienne (ANDIQ, France)
- Study start
- Jul 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 May 2013 (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.
HDQ 200 is an interventional multicenter study. This is a before-and-after design in which the patient is his own control. The main objective of the study is to determine the percentage of success of a procedure of daily hemodialysis at low dialysate flow. All patients treated with conventional hemodialysis, for at least 3 months and clinically stable, can be included in the study. Their 3 months data prior to inclusion is collected retrospectively. These 3 months of conventional hemodialysis are the reference period. Patients are then treated with daily hemodialysis at low dialysate flow for 3 months. During this 3 months period, the same data as during the period of conventional hemodialysis are collected prospectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily hemodialysis at low dialysate flow | Experimental | Other: Daily hemodialysis at low dialysate flow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Patients who give voluntary signed informed consent
- Patients affiliated with the French universal health care system or similar
- For women of childbearing potential: serum or urine negative pregnancy test
- Patients treated with conventional hemodialysis (3 times 4h to 5h per week at at least a dialysate flow rate of 500 ml/min) for at least 3 months and clinically stable (investigator assessment)
Key exclusion criteria (6 listed)
- Pregnant women or women who could become pregnant during the study (planned pregnancy within 3 months)
- Patients not affiliated with the French universal health care system
- Minor patients
- Patients who are protected adults according to the terms of the law (French public health laws).
- Refusal to give consent
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 |
|---|---|---|
| Daily hemodialysis at low dialysate flowDaily hemodialysis at low dialysate flow during 3 months: 6 times 2h to 2h30 per week at a dialysate flow rate of 200 ml/min in order that the total duration of weekly dialysis is equivalent to the duration of weekly dialysis during the last 3 months of conventional hemodialysis. Other parameters of dialysis (dialysate, dialysis machine, generator, blood flow, anticoagulation) are the same as the reference period of conventional hemodialysis. | Other | Daily hemodialysis at low dialysate flow |
Primary outcome
Number of patients for whom the period of daily hemodialysis at low dialysate flow will be a success.
Time frame: Every 2 weeks during 3 months.
Definition of success: if during the period of daily hemodialysis at low dialysate flow, the patient maintains the absolute value of their pre-dialysis serum creatinine (mid-week dialysis) below the upper limit of the confidence interval established during the 3 months prior to inclusion on 7 values: measurements every 2 weeks for 3 months (retrospective data) and inclusion measurement included (Day 0). Daily hemodialysis at low dialysate flow will be considered as a failure if pre-dialysis serum creatinine values exceed twice successively the upper limit of the confidence interval established for the patient.
17 secondary outcomes
Number of patients who stopped the daily hemodialysis at low dialysate flow (patient or investigator's decision).
Time frame: 3 months.
Number of patients who maintained a satisfactory clinical condition (investigator assessment) during the period of daily hemodialysis at low dialysate flow.
Time frame: 3 months.
Evaluation of weight.
Time frame: During 3 months (retrospectively and prospectively).
Evaluation of blood pressure.
Time frame: During 3 months (retrospectively and prospectively).
Evaluation of heart rate.
Time frame: During 3 months (retrospectively and prospectively).
Evaluation of body mass index.
Time frame: During 3 months (retrospectively and prospectively).
Evaluation of metabolic parameters.
Time frame: During 3 months (retrospectively and prospectively).
Evaluation of hematological parameters.
Time frame: During 3 months (retrospectively and prospectively).
Evaluation of inflammation parameters.
Time frame: During 3 months (retrospectively and prospectively).
Evaluation of nutrition parameters.
Time frame: During 3 months (retrospectively and prospectively).
Evaluation of iron parameters.
Time frame: During 3 months (retrospectively and prospectively).
Change in hormones.
Time frame: At inclusion and at 3 months.
Composite measurement of treatments.
Time frame: During 3 months (retrospectively and prospectively).
Composite measurement of technical dialysis parameters.
Time frame: During 3 months (retrospectively and prospectively).
List of symptoms and incidents between two hemodialysis, evaluation of hemodialysis tolerance, clinical assessment of the vascular access and possible local complications.
Time frame: At each hemodialysis during 3 months (retrospectively and prospectively).
Change in quality of life.
Time frame: At inclusion and at 3 months.
Change in pain.
Time frame: At inclusion and at 3 months.
Results and safety
The study was stopped early (reason given: Study has been prematurely halted because of failure of patient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
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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.
Maurice Laville, MD, PHD principal investigator
Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service de Néphrologie Bâtiment 3C, 3ème étage, Chemin du grand Revoyet 69495 PIERRE-BENITE
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily hemodialysis at low dialysate flow in people with End Stage Renal Disease, run by Association Pour L'utilisation Rein Artificiel Région Lyonnaise at 13 sites in 2 countries.
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 6 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: stopped early, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Belgium. 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 was stopped early (reason given: Study has been prematurely halted because of failure of patient recruitment.). Results are not available in the source record.
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?
Number of patients for whom the period of daily hemodialysis at low dialysate flow will be a success. (time frame: Every 2 weeks during 3 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 17 Mar 2017.