End Stage Renal DiseaseNCT01932853
Association Between Dose Dialysis by Kt and Mortality
An observational study of End Stage Renal Disease and Hemodialysis Patients, run by NephroCare Spain at 1 site in Spain.
Trial summary
The aim of this study is to assess whether patients receiving current recommendations of an adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months compared to those who do not get it, as well as assess whether patients receiving a dose greater obtain more benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis Patients
- How many people
- 6,129 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects: Patients> 18 years in hemodialysis treatment at any FMC center of Spain that meet the inclusion criteria. Data will be collected according to clinical practice and patients will be categorized according to their dose of Kt, along the two years of the study. Will seek the association of dialysis dose with mortality and hospitalization
Who may be able to join
- > 18 years old
- > six months on hemodialysis
- Receiving 3 sessions of dialysis per week
- Having 5 or more valid measures of Kt during the month
Who cannot join
- active chronic inflammatory diseases
- Liver cirrhosis
- Neoplasms
- Chronic immunosuppression or use of anti-inflammatory
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Association of Dialysis Dose Obtained by Kt and Mortality in Hemodialysis Patients
The aim of this study is to assess whether patients receiving current recommendations of an adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months compared to those who do not get it, as well as assess whether patients receiving a dose greater obtain more benefit.
- Conditions
- End Stage Renal Disease, Hemodialysis Patients
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | Patients > 18y hemodialysis for at least 6 months at any center of Spain Fresenius Medical Care (FMC) meeting the inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: two years
Secondary outcomes (1)
Hospitalization
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2015
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6,129 participants (actual)
Sponsor and investigators
- Lead sponsor
- NephroCare Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Rosa Ramos, NephroCare Spain
- Investigators
- Francesc Maduell, MD, Ph, Principal investigator, Servei Nefrologia, ICNU, Hospital Clínic.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932853
- Sponsor's protocol ID
- QM-RR-02
- Status last verified
- Oct 2015
- First submitted
- 27 Aug 2013
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association of Dialysis Dose Obtained by Kt and Mortality in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01932853
- Acronym / sponsor ID
- QM-RR-02
- Conditions
- End Stage Renal Disease, Hemodialysis Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,129 participants (actual)
- Lead sponsor
- NephroCare SpainIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Aug 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.
The aim of this study is to assess whether patients receiving current recommendations of an adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months compared to those who do not get it, as well as assess whether patients receiving a dose greater obtain more benefit.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | –Patients > 18y hemodialysis for at least 6 months at any center of Spain Fresenius Medical Care (FMC) meeting the inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects: Patients> 18 years in hemodialysis treatment at any FMC center of Spain that meet the inclusion criteria. Data will be collected according to clinical practice and patients will be categorized according to their dose of Kt, along the two years of the study. Will seek the association of dialysis dose with mortality and hospitalization
Key inclusion criteria (4 listed)
- > 18 years old
- > six months on hemodialysis
- Receiving 3 sessions of dialysis per week
- Having 5 or more valid measures of Kt during the month
Key exclusion criteria (4 listed)
- active chronic inflammatory diseases
- Liver cirrhosis
- Neoplasms
- Chronic immunosuppression or use of anti-inflammatory
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
Mortality
Time frame: two years
1 secondary outcome
Hospitalization
Time frame: two 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 Jul 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.
Francesc Maduell, MD, Ph principal investigator
Servei Nefrologia, ICNU, Hospital Clínic.
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 End Stage Renal Disease and Hemodialysis Patients, run by NephroCare Spain at 1 site in Spain.
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 4 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 13 Jul 2016. 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 Spain. 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?
Mortality (time frame: two years). 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 13 Jul 2016.