NCT00234130

Brief Summary

This study will determine whether a new form of home hemodialysis carried out at night during sleep reduces blood levels of hormone-like substances called cytokines that may cause fatigue and increase blood fats and sugar. Participants will stay twice in the Rockefeller Hospital and receive a standard diet and blood testing. Training for nocturnal hemodialysis will be provided at the nearby Manhattan Dialysis Center of The Rogosin Institute, affiliated with The Rockefeller University.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

June 3, 2009

Status Verified

June 1, 2009

Enrollment Period

3.8 years

First QC Date

October 5, 2005

Last Update Submit

June 2, 2009

Conditions

End-Stage Renal Disease

Keywords

DialysisCytokinesTriglyceridesInsulin

Outcome Measures

Primary Outcomes (1)

  • Feasibility study

Secondary Outcomes (1)

  • Feasibility study

Interventions

nocturnal vs conventional dialysisPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women at least age 18 who receive hemodialysis three times a week for at least 3 months and meet the criteria for home instruction in nocturnal dialysis -

You may not qualify if:

  • No diabetes, any unstable clinical condition, chronic infection (including hepatitis, HIV), endocrine disorders or serious digestive problems, lipid-lowering medication , LDL cholesterol \<190 mg/dL and triglycerides less than 600 mg/dL, body mass index \<35, blood pressure \<160/100, hemoglobin \>10.0, no cholesterol-lowering medicine, able to change from Renagel (has lipid effects) to Phoslo for the duration of the study, cigarette smoking no more than half a pack per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicInsulin Resistance

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lisa C. Hudgins, MD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2005

First Posted

October 6, 2005

Study Start

July 1, 2002

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

June 3, 2009

Record last verified: 2009-06

Locations

US(1)