End Stage Renal DiseaseNCT01721421
Effects of Extended Haemodialysis Treatment Duration in Patients With End-stage Renal Disease
A study testing extended treatment time and Standard treatment time in people with End Stage Renal Disease, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Design: Prospective randomised cross-over study. Fifty-two eligible patients will be randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and following a washout period of 4 weeks, switch to the alternative treatment time for an additional 24 weeks. 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?
- extended treatment time and Standard treatment time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Feb 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
- Dialysis dependant for over 90 days
Who cannot join
- Haemodialysis for less than 90 days
- Patients with anticipated life expectancy less than 6 months secondary to significant morbidity e.g. metastatic malignancy, advanced human immunodeficiency virus
- Patients with acute liver disease; History of underlying haematological condition;
- Elective planned change of renal replacement modality within the 12 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0HS
Seema Singh, MSc, +44 2083835249, s.singh11@imperial.ac.uk
Seema Singh, MSc
About this study
Official title: Feasibility and Physiological and Nutritional Effects of Extended Treatment Duration in Patients With End-stage Renal Disease on Haemodialysis
Design: Prospective randomised cross-over study. Fifty-two eligible patients will be randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and following a washout period of 4 weeks, switch to the alternative treatment time for an additional 24 weeks.
Aims: To examine the feasibility and effect of extended dialysis treatment time, 6 hours thrice weekly, versus the standard, 4 hours thrice weekly, comparing the differences from baseline in outcome measures over a total 12-month period.
Read more
Primary outcome measure
1]Serum albumin
Secondary outcome measures Nutritional status
- Malnutrition-inflammation score
- Dietary intake
- Hand-Grip strength
- Energy expenditure
Quality of life
- Patient reported quality of life and
- time to recovery from dialysis
Serum biomarkers
- BNP
- Troponin
- MCP-1
Others 24- hour Ambulatory blood pressure 24-hour accelerometer
Population: Local haemodialysis population of 1200 patients Eligibility: Minimum 90days on haemodialysis treatment Duration: Fifty-six weeks
- Conditions
- End Stage Renal Disease
- Being tested
- extended treatment time, Standard treatment time
- Keywords
- haemodialysis, Crossover, Treatment time, nutritional status
- 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.
extended treatment timeOther
patients receive extended dialysis treatment time time of 6 hours
Standard treatment timeOther
| Study group | Role | What they receive |
|---|---|---|
| Extended Treatment time | Experimental | Extended treatment time of 6 hours Receives: Other: extended treatment time; Other: Standard treatment time |
| standard treatment time | Active comparator | Standard Treatment time of 4 hours Receives: Other: extended treatment time; Other: Standard treatment time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum albumin
Measured: baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2014 (estimated)
- Study completionFeb 2015 (estimated)
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.
- More trials run by Imperial College LondonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Choi, MBcHB PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721421
- Sponsor's protocol ID
- 11-LL-0505
- Status last verified
- Nov 2012
- First submitted
- 1 Nov 2012
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Physiological and Nutritional Effects of Extended Treatment Duration in Patients With End-stage Renal Disease on Haemodialysis
- ClinicalTrials.gov ID
- NCT01721421
- Acronym / sponsor ID
- 11-LL-0505
- Conditions
- End Stage Renal Disease
- Keywords
- haemodialysis, Crossover, Treatment time, nutritional status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 5 Nov 2012 (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.
Design: Prospective randomised cross-over study. Fifty-two eligible patients will be randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and following a washout period of 4 weeks, switch to the alternative treatment time for an additional 24 weeks.
Aims: To examine the feasibility and effect of extended dialysis treatment time, 6 hours thrice weekly, versus the standard, 4 hours thrice weekly, comparing the differences from baseline in outcome measures over a total 12-month period.
Primary outcome measure
1]Serum albumin
Secondary outcome measures Nutritional status
- Malnutrition-inflammation score
- Dietary intake
- Hand-Grip strength
- Energy expenditure
Quality of life
- Patient reported quality of life and
- time to recovery from dialysis
Serum biomarkers
- BNP
- Troponin
- MCP-1
Others 24- hour Ambulatory blood pressure 24-hour accelerometer
Population: Local haemodialysis population of 1200 patients Eligibility: Minimum 90days on haemodialysis treatment Duration: Fifty-six weeks
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Treatment time | Experimental | Other: extended treatment time, Other: Standard treatment timeExtended treatment time of 6 hours |
| standard treatment time | Active comparator | Other: extended treatment time, Other: Standard treatment timeStandard Treatment time of 4 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dialysis dependant for over 90 days
Key exclusion criteria (4 listed)
- Haemodialysis for less than 90 days
- Patients with anticipated life expectancy less than 6 months secondary to significant morbidity e.g. metastatic malignancy, advanced human immunodeficiency virus
- Patients with acute liver disease; History of underlying haematological condition;
- Elective planned change of renal replacement modality within the 12 months.
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 |
|---|---|---|
| extended treatment timepatients receive extended dialysis treatment time time of 6 hours | Other | Extended Treatment time, standard treatment time |
| Standard treatment time | Other | Extended Treatment time, standard treatment time |
Primary outcome
Serum albumin
Time frame: baseline to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2012.
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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.
Peter Choi, MBcHB PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extended treatment time and Standard treatment time in people with End Stage Renal Disease, run by Imperial College London at 1 site in United Kingdom.
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 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: status not confirmed, as of the sponsor's last update on 5 Nov 2012. 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 United Kingdom. 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 Seema Singh (+44 208 3835249, s.singh11@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum albumin (time frame: baseline to 24 weeks). 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 5 Nov 2012.