End Stage Renal DiseasePhase 3SHDNCT00939445
Short Daily Hemodialysis and Online HDF: Which One is Better?
A Phase 3 study testing Online HDF and Short Daily Hemodialysis in people with End Stage Renal Disease, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
Trial summary
1. To compare the efficacy of 1. Short Daily Hemodialysis 2. Online HDF in term of adequacy of dialysis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Online HDF and Short Daily Hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2009to Sep 2011
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable ESRD
- KT/V > 1.2 for thrice weekly or > 1.8 for twice weekly
Who cannot join
- Inadequate vascular access flow rate
- Concurrent medical illnesses
- History of non-compliance
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Renal Unit, BMA Medical College and Vajira Hospital
Bangkok, 10300
About this study
- To compare the efficacy of
- Short Daily Hemodialysis
- Online HDF in term of adequacy of dialysis.
Read the detailed description
The investigators intend to compare the efficacy between these modalities of treatment in terms of adequacy and also other parameters such as calcium-phosphorus balance and hematocrit
- Conditions
- End Stage Renal Disease
- Being tested
- Online HDF, Short Daily Hemodialysis
- 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.
Online HDFProcedure or surgery
Online HDF
Short Daily HemodialysisProcedure or surgery
Short Daily Hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Online HDF | Active comparator | Online HDF Receives: Procedure: Online HDF |
| Short Daily Hemodialysis | Active comparator | Short Daily Hemodialysis Receives: Procedure: Short Daily Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy
Measured: 3 months
Secondary outcomes (1)
Hematocrit, calcium, phosphorus
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2011
- Study completionSep 2011
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939445
- Sponsor's protocol ID
- VJR-NEPHRO001
- Acronym
- SHD
- Status last verified
- Dec 2015
- First submitted
- 14 Jul 2009
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Daily Hemodialysis and Online HDF: Which One is Better?
- ClinicalTrials.gov ID
- NCT00939445
- Acronym / sponsor ID
- SHD / VJR-NEPHRO001
- Conditions
- End Stage Renal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
- Study start
- Jun 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Jul 2009 (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.
- To compare the efficacy of
- Short Daily Hemodialysis
- Online HDF in term of adequacy of dialysis.
Detailed description
The investigators intend to compare the efficacy between these modalities of treatment in terms of adequacy and also other parameters such as calcium-phosphorus balance and hematocrit
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online HDF | Active comparator | Procedure: Online HDFOnline HDF |
| Short Daily Hemodialysis | Active comparator | Procedure: Short Daily HemodialysisShort Daily Hemodialysis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable ESRD
- KT/V > 1.2 for thrice weekly or > 1.8 for twice weekly
Key exclusion criteria (3 listed)
- Inadequate vascular access flow rate
- Concurrent medical illnesses
- History of non-compliance
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 |
|---|---|---|
| Online HDFOnline HDF | Procedure or surgery | Online HDF |
| Short Daily HemodialysisShort Daily Hemodialysis | Procedure or surgery | Short Daily Hemodialysis |
Primary outcome
Adequacy
Time frame: 3 months
1 secondary outcome
Hematocrit, calcium, phosphorus
Time frame: 3 months
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 15 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Online HDF and Short Daily Hemodialysis in people with End Stage Renal Disease, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
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 2 inclusion and 3 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 15 Dec 2015. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adequacy (time frame: 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 15 Dec 2015.