End Stage Renal DiseaseNCT01775800
Treatment Modification to Reduce Symptom Burden in Hemodialysis
A study testing Treatment modification in people with End Stage Renal Disease, run by The Rogosin Institute at 1 site in United States.
Trial summary
Many patients on hemodialysis experience high rates of symptom burden, such as pain, depression, anxiety and difficulty breathing. This study seeks to reduce these symptoms by modifying the usual guidelines used to manage patients on hemodialysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Treatment modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- hemodialysis patient
- transplant ineligible
Who cannot join
- dementia
- unable to answer questionnaires for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Modification and Symptom Burden in High-Risk Dialysis Patients
Many patients on hemodialysis experience high rates of symptom burden, such as pain, depression, anxiety and difficulty breathing. This study seeks to reduce these symptoms by modifying the usual guidelines used to manage patients on hemodialysis. For example, rather than trying to keep serum phosphorus below 5.5, patients enrolled in this study may have treatment goals of less than 6.5, in order to reduce the number of pills they need to take and potentially reduce harmful side effects. Blood pressure and serum parathyroid hormone goals will also be modified, to see if these modifications help hemodialysis patients feel better.
- Conditions
- End Stage Renal Disease
- Being tested
- Treatment modification
- 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.
Treatment modificationOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment modification | Experimental | Patients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus. Receives: Other: Treatment modification |
| Usual care | No intervention | Patients will receive the usual hemodialysis care with no modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Recruited, Consented, Randomized and Completed
Measured: Each participant was assessed for 6 weeks; total recruitment period was 15 months
Secondary outcomes (1)
Symptom Burden
Number of symptoms in past week as measured by the Dialysis Symptom Index
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rogosin Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Nathaniel Berman, M.D., Principal investigator, The Rogosin Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775800
- Sponsor's protocol ID
- 1207012494
- Status last verified
- Sep 2018
- First submitted
- 16 Jan 2013
- Last updated
- 9 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Berman N, Reid MC, Teresi J, Eimicke JP, Adelman R. More with Less: A Trial of Reduced-Intensity Treatment in Transplant-Ineligible Hemodialysis Patients. J Palliat Med. 2016 May;19(5):503-8. doi: 10.1089/jpm.2015.0338.
PubMed 27139523
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Modification and Symptom Burden in High-Risk Dialysis Patients
- ClinicalTrials.gov ID
- NCT01775800
- Acronym / sponsor ID
- 1207012494
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Rogosin InstituteUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Jan 2013 (estimated)
- Results
- Posted 9 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many patients on hemodialysis experience high rates of symptom burden, such as pain, depression, anxiety and difficulty breathing. This study seeks to reduce these symptoms by modifying the usual guidelines used to manage patients on hemodialysis. For example, rather than trying to keep serum phosphorus below 5.5, patients enrolled in this study may have treatment goals of less than 6.5, in order to reduce the number of pills they need to take and potentially reduce harmful side effects. Blood pressure and serum parathyroid hormone goals will also be modified, to see if these modifications help hemodialysis patients feel better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment modification | Experimental | Other: Treatment modificationPatients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus. |
| Usual care | No intervention | –Patients will receive the usual hemodialysis care with no modifications |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- hemodialysis patient
- transplant ineligible
Key exclusion criteria (2 listed)
- dementia
- unable to answer questionnaires for any reason
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 |
|---|---|---|
| Treatment modification | Other | Treatment modification |
Primary outcome
Number of Participants Recruited, Consented, Randomized and Completed
Time frame: Each participant was assessed for 6 weeks; total recruitment period was 15 months
1 secondary outcome
Symptom Burden
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27139523Berman N, Reid MC, Teresi J, Eimicke JP, Adelman R. More with Less: A Trial of Reduced-Intensity Treatment in Transplant-Ineligible Hemodialysis Patients. J Palliat Med. 2016 May;19(5):503-8. doi: 10.1089/jpm.2015.0338.
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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.
Nathaniel Berman, M.D. principal investigator
The Rogosin Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment modification in people with End Stage Renal Disease, run by The Rogosin Institute at 1 site 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 2 inclusion and 2 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 9 Oct 2018. 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 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?
Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Recruited, Consented, Randomized and Completed (time frame: Each participant was assessed for 6 weeks; total recruitment period was 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01775800, which also lists 1 linked publication.
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 9 Oct 2018; AzTrials last refreshed its copy on 26 Oct 2026.