NCT01267760

Brief Summary

The purpose of this study is to investigate whether recycled dialysis fluid can supply enough clearance for hemodiaysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2010

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 28, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 9, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

January 26, 2010

Last Update Submit

July 6, 2013

Conditions

Uremia

Keywords

dialysishemodialysisEffect of recycled low-volume dialysate on dialysis efficacy

Outcome Measures

Primary Outcomes (1)

  • Urea Kt/V

    9 hours

Secondary Outcomes (2)

  • Creatinine clearance

    9 hours

  • Patient symptoms

    9 hours

Study Arms (1)

conventional HD

ACTIVE COMPARATOR

conventional 4-hour HD

Device: Multipass hemodialysis

Interventions

Multipass hemodialysisDEVICE

8-hour dialysis using a recycled dialysis bath of 25-30 l

Also known as: dialysis, hemodialysis, dialysate
conventional HD

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable chronic HD patients
  • Informed consent

You may not qualify if:

  • Age \<18 years
  • Psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, Denmark, 2880, Denmark

Location

Related Publications (2)

  • Heaf JG, Axelsen M, Pedersen RS. Multipass haemodialysis: a novel dialysis modality. Nephrol Dial Transplant. 2013 May;28(5):1255-64. doi: 10.1093/ndt/gfs484. Epub 2012 Nov 7.

    PMID: 23136214RESULT

  • Eloot S, Van Biesen W, Axelsen M, Glorieux G, Pedersen RS, Heaf JG. Protein-bound solute removal during extended multipass versus standard hemodialysis. BMC Nephrol. 2015 Apr 18;16:57. doi: 10.1186/s12882-015-0056-y.

    PMID: 25896788DERIVED

MeSH Terms

Conditions

Uremia

Interventions

DialysisRenal Dialysis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative TechniquesChemical PhenomenaRenal Replacement TherapyTherapeuticsSorption Detoxification

Study Officials

  • James G Heaf, MD DMSc

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

January 26, 2010

First Posted

December 28, 2010

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 9, 2013

Record last verified: 2013-07

Locations

DK(1)