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More Frequent In-Center Hemodialysis in Pediatric End Stage Renal Disease

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ClinicalTrials.gov Identifier: NCT01352455
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : December 31, 2013
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Pediatric End Stage Renal Disease Hemodialysis Procedure: Hemodialysis

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of More Frequent In-Center Hemodialysis to Improve Outcomes in Pediatric End Stage Renal Disease
Study Start Date : March 2011
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 5 days per week hemodialysis
5 days per week, 2 hours 20 minutes per session versus 3 days per week, 4 hours per session
Procedure: Hemodialysis
5 days per week hemodialysis

Outcome Measures

Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: up to 24 weeks ]

Secondary Outcome Measures :
  1. Diastolic Blood Pressure [ Time Frame: up to 24 weeks ]
  2. Treatment Costs [ Time Frame: up to 24 weeks ]
  3. Quality of Life [ Time Frame: up to 24 weeks ]
  4. Adverse Events/Symptoms [ Time Frame: up to 24 weeks ]
  5. Bone Health [ Time Frame: up to 24 weeks ]
  6. Anemia [ Time Frame: up to 24 weeks ]
  7. Nutrition and Growth [ Time Frame: up to 24 weeks ]
  8. Echocardiogram measured left ventricular mass [ Time Frame: every 3 months ]
  9. School Performance [ Time Frame: every 3 months ]
  10. Inflammatory Markers [ Time Frame: every 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352455

United States, Ohio
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
The Hospital for Sick Children
Toronto, Canada
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
The Hospital for Sick Children
Principal Investigator: Benjamin L Laskin, MD Children's Hospital of Philadelphia
More Information

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01352455     History of Changes
Other Study ID Numbers: 2010-0596
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013

Keywords provided by Children's Hospital of Philadelphia:
Comparative Effectiveness
End Stage Renal Disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency