End Stage Renal DiseaseMFDNCT00575497
More Frequent Dialysis (>3 Treatments Per Week)
A study testing More frequent hemodialysis and Conventional Hemodialysis in people with End Stage Renal Disease and Chronic Kidney Disease, run by Satellite Healthcare at 2 sites in United States.
Trial summary
The study compares the benefits of short daily hemodialysis six days a week, nocturnal (night time) hemodialysis six days a week, every other day and every other night hemodialysis to traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis treatment time and/or frequency will improve… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease, Chronic Kidney Disease
- What is being tested?
- More frequent hemodialysis and Conventional Hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to 7 Aug 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stable vascular access, i.e., lack of needling difficulties and stable flow rates. Accesses will include fistulae, grafts, catheters and ports.
- 18 years of age.
- History of compliance with a dialysis treatment schedule, or if a new patient, express a willingness to be compliant with a treatment schedule.
- Plan to continue care and follow-up at the investigational site.
- Able to sign the informed consent and other relevant documents.
Who cannot join
- History of poor compliance with thrice (or twice) weekly dialysis schedules as manifested by more than three unexplained missed treatments in the past six (6) months.
- Pregnancy.
- Intravenous drug abuser.
- Expects to receive a transplant or transfer to another facility within six months of entering the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Satellite Healthcare, Inc.
Mountain View, California, 64041
WellBound, Inc.
Mountain View, California, 94041
About this study
Official title: Study of Clinical Outcomes of More Frequent Hemodialysis
The study compares the benefits of short daily hemodialysis six days a week, nocturnal (night time) hemodialysis six days a week, every other day and every other night hemodialysis to traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis treatment time and/or frequency will improve outcomes.
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease
- Being tested
- More frequent hemodialysis, Conventional Hemodialysis
- Keywords
- Hemodialysis, Adequacy, Frequency
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
More frequent hemodialysisProcedure or surgery
Six Day per week short daily hemodialysis
More frequent hemodialysisProcedure or surgery
Six nights per week nocturnal hemodialysis
More frequent hemodialysisProcedure or surgery
Every other day short daily hemodialysis
More frequent hemodialysisProcedure or surgery
Every other night hemodialysis
More frequent hemodialysisProcedure or surgery
5 days per week short daily hemodialysis
More frequent hemodialysisProcedure or surgery
5 nights per week hemodialysis
Conventional HemodialysisProcedure or surgery
3 days per week short daily hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Six Day per week short daily hemodialysis Receives: Procedure: More frequent hemodialysis |
| B | Experimental | Six nights per week nocturnal hemodialysis Receives: Procedure: More frequent hemodialysis |
| C | Experimental | Every other day short daily hemodialysis Receives: Procedure: More frequent hemodialysis |
| D | Experimental | Every other night hemodialysis Receives: Procedure: More frequent hemodialysis |
| E | Experimental | 5 days per week short daily hemodialysis Receives: Procedure: More frequent hemodialysis |
| F | Experimental | 5 nights per week hemodialysis Receives: Procedure: More frequent hemodialysis |
| G | Active comparator | Conventional three time per week short daily hemodialysis Receives: Procedure: Conventional Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization days per year
Measured: Ongoing
Secondary outcomes (4)
Nutritional Status measured by Subjective Global Assessment
Measured: Ongoing
Anemia, measured by erythropoetin dose
Measured: Ongoing
Control of hypertension, as measured by number of antihypertensive tablets taken per day
Measured: Ongoing
Control of hyperphosphatemia, as measured by number of phosphate binder tablets taken per day
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJan 2005
- Primary completion7 Aug 2012
- Study completion7 Aug 2012
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Moran, MD, Study director, Satellite Healthcare, Inc.Brigittte Schiller-Moran, MD, Principal investigator, Satellite Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575497
- Sponsor's protocol ID
- SR002MFD
- Acronym
- MFD
- Status last verified
- Apr 2019
- First submitted
- 14 Dec 2007
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical Outcomes of More Frequent Hemodialysis
- ClinicalTrials.gov ID
- NCT00575497
- Acronym / sponsor ID
- MFD / SR002MFD
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease
- Keywords
- Hemodialysis, Adequacy, Frequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- 7 Aug 2012 (actual)
- Study completion
- 7 Aug 2012 (actual)
- First posted
- 18 Dec 2007 (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 study compares the benefits of short daily hemodialysis six days a week, nocturnal (night time) hemodialysis six days a week, every other day and every other night hemodialysis to traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis treatment time and/or frequency will improve outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: More frequent hemodialysisSix Day per week short daily hemodialysis |
| B | Experimental | Procedure: More frequent hemodialysisSix nights per week nocturnal hemodialysis |
| C | Experimental | Procedure: More frequent hemodialysisEvery other day short daily hemodialysis |
| D | Experimental | Procedure: More frequent hemodialysisEvery other night hemodialysis |
| E | Experimental | Procedure: More frequent hemodialysis5 days per week short daily hemodialysis |
| F | Experimental | Procedure: More frequent hemodialysis5 nights per week hemodialysis |
| G | Active comparator | Procedure: Conventional HemodialysisConventional three time per week short daily hemodialysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Stable vascular access, i.e., lack of needling difficulties and stable flow rates. Accesses will include fistulae, grafts, catheters and ports.
- 18 years of age.
- History of compliance with a dialysis treatment schedule, or if a new patient, express a willingness to be compliant with a treatment schedule.
- Plan to continue care and follow-up at the investigational site.
- Able to sign the informed consent and other relevant documents.
Key exclusion criteria (4 listed)
- History of poor compliance with thrice (or twice) weekly dialysis schedules as manifested by more than three unexplained missed treatments in the past six (6) months.
- Pregnancy.
- Intravenous drug abuser.
- Expects to receive a transplant or transfer to another facility within six months of entering the study.
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 |
|---|---|---|
| More frequent hemodialysisSix Day per week short daily hemodialysis | Procedure or surgery | A |
| More frequent hemodialysisSix nights per week nocturnal hemodialysis | Procedure or surgery | B |
| More frequent hemodialysisEvery other day short daily hemodialysis | Procedure or surgery | C |
| More frequent hemodialysisEvery other night hemodialysis | Procedure or surgery | D |
| More frequent hemodialysis5 days per week short daily hemodialysis | Procedure or surgery | E |
| More frequent hemodialysis5 nights per week hemodialysis | Procedure or surgery | F |
| Conventional Hemodialysis3 days per week short daily hemodialysis | Procedure or surgery | G |
Primary outcome
Hospitalization days per year
Time frame: Ongoing
4 secondary outcomes
Nutritional Status measured by Subjective Global Assessment
Time frame: Ongoing
Anemia, measured by erythropoetin dose
Time frame: Ongoing
Control of hypertension, as measured by number of antihypertensive tablets taken per day
Time frame: Ongoing
Control of hyperphosphatemia, as measured by number of phosphate binder tablets taken per day
Time frame: Ongoing
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 19 Apr 2019.
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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.
John Moran, MD study director
Satellite Healthcare, Inc.
Brigittte Schiller-Moran, MD principal investigator
Satellite Healthcare, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing More frequent hemodialysis and Conventional Hemodialysis in people with End Stage Renal Disease and Chronic Kidney Disease, run by Satellite Healthcare at 2 sites in United States.
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 5 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 19 Apr 2019. 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 United States. 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?
Hospitalization days per year (time frame: Ongoing). 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 19 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.