Kidney DiseaseIVPNCT01947829
Interdialytic Kt/V Variability Measurement With Adimea (IVP STUDY)
An observational study of Kidney Disease, run by B.Braun Avitum AG at 2 sites in China.
Trial summary
Session-to-session variations in delivered Kt/V that may cause failure to achieve the prescribed dialysis dose may be significant in regular clinical practice. To date, this is not recognized due to monthly blood Kt/V measurements only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2013to Dec 2014
- 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: Patients on chronic hemodialysis.
Who may be able to join
- Patient on chronic hemodialysis for at least 6 months
- Thrice dialysis therapy weekly
- Stable fistula access
- Documented three, monthly blood spKt/V from 1.0 to 1.4 or
- Average of spKt/V<1.35 out of three consecutive blood measurements
- Age ≥ 18 years
- Voluntary participation and written informed consent
Who cannot join
- Severe hematologic disorders (e.g. multiple myeloma)
- Life expectancy less than 6 months
- Single-needle dialysis
- Patient was monitored with Adimea
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Friendship Hospital,Capital Medical University
Beijing, 100050
China PLA General Hospital (301 hospital)
Beijing, 100853
About this study
Session-to-session variations in delivered Kt/V that may cause failure to achieve the prescribed dialysis dose may be significant in regular clinical practice. To date, this is not recognized due to monthly blood Kt/V measurements only. Suboptimal delivery of prescribed dialysis dose may be caused by low effective treatment time, vascular access dysfunction, hemodynamic stability, blood pump speed, membrane influences, lab value variability or others which may vary from session to session. Patients close to recommended target limits of dialysis dose may thus be "randomly" attributed to be adequately or inadequately dialyzed. Therefore, in the literature, use of average Kt/V values is recommended.
Adimea allows easy Kt/V determination in every session and thus documentation of the monthly achieved Kt/V in patients who repeatedly miss Kt/V. Knowledge, therefore, of session-to-session variability as well as knowledge of dialysis dose monitoring at every dialysis may enhance and secure delivery of adequate dialysis.
The main objective is the estimation of the pooled within-patient SDs (standard deviation) for single treatment Adimea and of urea kinetic modeling (UKM)/ blood spKt/V. Failure of Kt/V>1.2 delivery as well as its potential causes will be assessed. spKt/V target achievement is assessed by monitoring dose by Adimea at every dialysis. This shall demonstrate that session-to-session variability can be decreased with usage of Adimea.
- Conditions
- Kidney Disease
- Keywords
- hemodialysis, dialysis dose
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Hemodialysis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis dose (spKt/V) measured by Adimea and Urea Kinetic Modeling (UKM)
Measured: Six months prospective
Secondary outcomes (9)
Treatment time
Dialysis time per session
Measured: Six months prospective
Blood flow rate
Initial blood flow rate [ml/min] at the beginning of dialysis session.
Measured: 6 months prospective
Dialysate flow rate
Initial dialysate flow rate [ml/min] at the beginning of dialysis session.
Measured: 6 months prospective
Ultrafiltration volume
Ultrafiltration volume [ml] reached at the end of dialysis session.
Measured: 6 months prospective
Dialyser size
Membrane surface size [m2] of the dialyser used during dialysis session.
Measured: 6 months prospective
Hemoglobin
Hemoglobin level [mmol/l or g/dl] before dialysis.
Measured: 6 months prospective
Hematocrit
Hematocrit level [%] before dialysis.
Measured: 6 months prospective
Intact parathyroid hormone (iPTH)
Intact parathyroid hormone level [pmol/l or ng/l] before dialysis.
Measured: 6 months prospective
C-reactive protein (CRP)
C-reactive protein level [mg/l or g/dl] before dialysis.
Measured: 6 months prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.Braun Avitum AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiangmei Chen, Prof., Principal investigator, China PLA General Hospital (301 hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947829
- Sponsor's protocol ID
- BA-O-H-1205
- Acronym
- IVP
- Status last verified
- Nov 2016
- First submitted
- 18 Sep 2013
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdialytic Kt/V Variability Measurement With Adimea (IVP STUDY)
- ClinicalTrials.gov ID
- NCT01947829
- Acronym / sponsor ID
- IVP / BA-O-H-1205
- Conditions
- Kidney Disease
- Keywords
- hemodialysis, dialysis dose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- B.Braun Avitum AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- First posted
- 23 Sep 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.
Session-to-session variations in delivered Kt/V that may cause failure to achieve the prescribed dialysis dose may be significant in regular clinical practice. To date, this is not recognized due to monthly blood Kt/V measurements only. Suboptimal delivery of prescribed dialysis dose may be caused by low effective treatment time, vascular access dysfunction, hemodynamic stability, blood pump speed, membrane influences, lab value variability or others which may vary from session to session. Patients close to recommended target limits of dialysis dose may thus be "randomly" attributed to be adequately or inadequately dialyzed. Therefore, in the literature, use of average Kt/V values is recommended.
Adimea allows easy Kt/V determination in every session and thus documentation of the monthly achieved Kt/V in patients who repeatedly miss Kt/V. Knowledge, therefore, of session-to-session variability as well as knowledge of dialysis dose monitoring at every dialysis may enhance and secure delivery of adequate dialysis.
The main objective is the estimation of the pooled within-patient SDs (standard deviation) for single treatment Adimea and of urea kinetic modeling (UKM)/ blood spKt/V. Failure of Kt/V>1.2 delivery as well as its potential causes will be assessed. spKt/V target achievement is assessed by monitoring dose by Adimea at every dialysis. This shall demonstrate that session-to-session variability can be decreased with usage of Adimea.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Hemodialysis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on chronic hemodialysis.
Key inclusion criteria (7 listed)
- Patient on chronic hemodialysis for at least 6 months
- Thrice dialysis therapy weekly
- Stable fistula access
- Documented three, monthly blood spKt/V from 1.0 to 1.4 or
- Average of spKt/V<1.35 out of three consecutive blood measurements
Key exclusion criteria (4 listed)
- Severe hematologic disorders (e.g. multiple myeloma)
- Life expectancy less than 6 months
- Single-needle dialysis
- Patient was monitored with Adimea
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
Dialysis dose (spKt/V) measured by Adimea and Urea Kinetic Modeling (UKM)
Time frame: Six months prospective
9 secondary outcomes
Treatment time
Time frame: Six months prospective
Blood flow rate
Time frame: 6 months prospective
Dialysate flow rate
Time frame: 6 months prospective
Ultrafiltration volume
Time frame: 6 months prospective
Dialyser size
Time frame: 6 months prospective
Hemoglobin
Time frame: 6 months prospective
Hematocrit
Time frame: 6 months prospective
Intact parathyroid hormone (iPTH)
Time frame: 6 months prospective
C-reactive protein (CRP)
Time frame: 6 months prospective
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 23 Nov 2016.
Related trials for Kidney Disease
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
Primary Membranous Nephropathy
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
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.
Xiangmei Chen, Prof. principal investigator
China PLA General Hospital (301 hospital)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease, run by B.Braun Avitum AG at 2 sites in China.
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 4 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Dialysis dose (spKt/V) measured by Adimea and Urea Kinetic Modeling (UKM) (time frame: Six months prospective). 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 23 Nov 2016.