Pediatric End Stage Renal DiseaseNCT01352455
More Frequent In-Center Hemodialysis in Pediatric End Stage Renal Disease
A study testing Hemodialysis in people with Pediatric End Stage Renal Disease and Hemodialysis, run by Children's Hospital of Philadelphia at 3 sites in 2 countries.
Trial summary
A health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the body. Many children with permanent kidney failure undergo dialysis, a life saving procedure that takes the place of a kidney. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Pediatric End Stage Renal Disease, Hemodialysis
- What is being tested?
- Hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2011to Sep 2013
- 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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Current outpatient ESRD pediatric patients, 3-21 years old, receiving in-center chronic HD.
- Patients have to be on chronic HD for at least 2 months before eligibility
Who cannot join
- Patients with a scheduled (with a specific transplant date) kidney transplant in the next 6 months
- Patients scheduled to be switched to peritoneal dialysis in the next 6 months
- Patients currently receiving >3 days per week of hemodialysis
- Patients currently receiving >12 hours per week of hemodialysis
- Anyone <3 years of age would be excluded from the study, so our minimum anticipated patient weight would be about 11 kg
- Patients >21 years of age at enrollment
Show all 12Show fewer
- Patients receiving concomitant peritoneal dialysis
- Patients with <2 months on chronic HD
- Patients with a temporary or femoral dialysis catheter
- Patients who are not hypertensive (both not on blood pressure medication and with a SBP <95th percentile for age, sex, and height)
- Patients enrolled in an investigational drug trial involving blood pressure medication or any other clinical trial potentially affecting the primary outcome of the study
- Patients listed for a deceased donor transplant will not be excluded.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study of More Frequent In-Center Hemodialysis to Improve Outcomes in Pediatric End Stage Renal Disease
A health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the body. Many children with permanent kidney failure undergo dialysis, a life saving procedure that takes the place of a kidney. Currently, many children with permanent kidney failure only receive dialysis treatments 3 days a week in the hospital dialysis clinic. Children on dialysis have a markedly reduced life expectancy, with a life span 40-50 years shorter than their healthy counterparts. Survival for these children has not improved over the last 20 years. These data indicate that the current dialysis treatment strategy is unacceptable.
This research project will study if more frequent dialysis, performed 5 days per week, will improve the health of children with permanent kidney failure compared to the current treatment strategy. Children will be treated with both traditional and more frequent dialysis schedules to measure improvements in their health and well being.
- Conditions
- Pediatric End Stage Renal Disease, Hemodialysis
- Being tested
- Hemodialysis
- Keywords
- Hemodialysis, Pediatric, Outcomes, Comparative Effectiveness, End Stage Renal Disease
- 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.
HemodialysisProcedure or surgery
5 days per week hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| 5 days per week hemodialysis | Experimental | 5 days per week, 2 hours 20 minutes per session versus 3 days per week, 4 hours per session Receives: Procedure: Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Measured: up to 24 weeks
Secondary outcomes (10)
Diastolic Blood Pressure
Measured: up to 24 weeks
Treatment Costs
Measured: up to 24 weeks
Quality of Life
Measured: up to 24 weeks
Adverse Events/Symptoms
Measured: up to 24 weeks
Bone Health
Measured: up to 24 weeks
Anemia
Measured: up to 24 weeks
Nutrition and Growth
Measured: up to 24 weeks
Echocardiogram measured left ventricular mass
Measured: every 3 months
School Performance
Measured: every 3 months
Inflammatory Markers
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin L Laskin, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352455
- Sponsor's protocol ID
- 2010-0596
- Status last verified
- Dec 2013
- First submitted
- 9 May 2011
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of More Frequent In-Center Hemodialysis to Improve Outcomes in Pediatric End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT01352455
- Acronym / sponsor ID
- 2010-0596
- Conditions
- Pediatric End Stage Renal Disease, Hemodialysis
- Keywords
- Hemodialysis, Pediatric, Outcomes, Comparative Effectiveness, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, The Hospital for Sick Children
- Study start
- Mar 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 May 2011 (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.
A health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the body. Many children with permanent kidney failure undergo dialysis, a life saving procedure that takes the place of a kidney. Currently, many children with permanent kidney failure only receive dialysis treatments 3 days a week in the hospital dialysis clinic. Children on dialysis have a markedly reduced life expectancy, with a life span 40-50 years shorter than their healthy counterparts. Survival for these children has not improved over the last 20 years. These data indicate that the current dialysis treatment strategy is unacceptable.
This research project will study if more frequent dialysis, performed 5 days per week, will improve the health of children with permanent kidney failure compared to the current treatment strategy. Children will be treated with both traditional and more frequent dialysis schedules to measure improvements in their health and well being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5 days per week hemodialysis | Experimental | Procedure: Hemodialysis5 days per week, 2 hours 20 minutes per session versus 3 days per week, 4 hours per session |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Current outpatient ESRD pediatric patients, 3-21 years old, receiving in-center chronic HD.
- Patients have to be on chronic HD for at least 2 months before eligibility
Key exclusion criteria (12 listed)
- Patients with a scheduled (with a specific transplant date) kidney transplant in the next 6 months
- Patients scheduled to be switched to peritoneal dialysis in the next 6 months
- Patients currently receiving >3 days per week of hemodialysis
- Patients currently receiving >12 hours per week of hemodialysis
- Anyone <3 years of age would be excluded from the study, so our minimum anticipated patient weight would be about 11 kg
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 |
|---|---|---|
| Hemodialysis5 days per week hemodialysis | Procedure or surgery | 5 days per week hemodialysis |
Primary outcome
Systolic Blood Pressure
Time frame: up to 24 weeks
10 secondary outcomes
Diastolic Blood Pressure
Time frame: up to 24 weeks
Treatment Costs
Time frame: up to 24 weeks
Quality of Life
Time frame: up to 24 weeks
Adverse Events/Symptoms
Time frame: up to 24 weeks
Bone Health
Time frame: up to 24 weeks
Anemia
Time frame: up to 24 weeks
Nutrition and Growth
Time frame: up to 24 weeks
Echocardiogram measured left ventricular mass
Time frame: every 3 months
School Performance
Time frame: every 3 months
Inflammatory Markers
Time frame: every 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 31 Dec 2013.
Related trials for Pediatric End Stage Renal Disease
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Ramipril vs. Amlodipine in Pediatric Hemodialysis Patients
Endothelial Dysfunction, End-Stage Renal Disease
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Phase 3 Clinical Trial With Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
Chronic Kidney Failure in Children and Young Adults
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A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
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Anemia
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.
Benjamin L Laskin, MD principal investigator
Children's Hospital of Philadelphia
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis in people with Pediatric End Stage Renal Disease and Hemodialysis, run by Children's Hospital of Philadelphia at 3 sites in 2 countries.
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 12 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 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
Systolic Blood Pressure (time frame: up 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 31 Dec 2013.