More Frequent In-Center Hemodialysis in Pediatric End Sta... | NCT01352455

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

NCT01352455

Sponsor

Children's Hospital of Philadelphia

Status

Completed

Last Update Posted

Dec 31, 2013Estimated

Enrollment

7Actual

Phase

Not Applicable

Conditions

Pediatric End Stage Renal Disease
Hemodialysis

Interventions

Hemodialysis

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

May 9, 2011

First Submission Date that Met QC Criteria

May 10, 2011

First Posted Date

May 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2013

Last Update Posted Date

Dec 31, 2013Estimated

Name	Class
Children's Hospital Medical Center, Cincinnati	OTHER
The Hospital for Sick Children	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Procedure: Hemodialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hemodialysis	Procedure	5 days per week hemodialysis	5 days per week hemodialysis

Measure	Description	Time Frame
Systolic Blood Pressure		up to 24 weeks

Measure	Description	Time Frame
Diastolic Blood Pressure		up to 24 weeks
Treatment Costs		up to 24 weeks
Quality of Life

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin L Laskin, MD	Children's Hospital of Philadelphia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Childrens Hospital Medical Center		Cincinnati	Ohio	45229	United States
Children's Hospital of Philadelphia

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D016060	Sorption Detoxification