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CompletedNCT01267760MHDUpdated Jul 9, 2013

Clinical and Biochemical Effects of Multipass Hemodialysis

A Phase 2 interventional study of Multipass hemodialysis in Uremia, sponsored by Herlev Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-07-09.

Sponsored by Herlev Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

Read the detailed description

Conventional hemodialysis uses large amounts of water, which hinders travel possibilies for home hemodialysis (HD) patients. We have developed a recycling system using 25-30 l dialysate per dialysis. In vitro investigations show that this results in adequate dialysis.

12 HD patients will be studied during two dialysis sessions. The first HD will be a conventional 4 hour dialysis, using single pass dialysate. The second will be an 8-hour HD using multipass (recycled) dialysate 25-30 l. Clearance of urea, creatinine, phosphate and cobalamin will be measured both in the patient and the dialysate. Patient symptoms will be recorded.

02

Conditions studied

  • Uremia

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Keywords

  • dialysis
  • hemodialysis
  • Effect of recycled low-volume dialysate on dialysis efficacy
03

In context

Uremia

53 studies on the registry are indexed under Uremia; 10 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 38 interventional studies indexed under Uremia.

Browse Uremia studies →

Lead sponsor

Herlev Hospital is the lead sponsor of 201 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Stable chronic HD patients

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years
  • Psychiatric disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    conventional HD

    conventional 4-hour HD

    Device: Multipass hemodialysis

Interventions

  • DeviceMultipass hemodialysis

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

    Also known as: dialysis, hemodialysis, dialysate

06

What researchers measure

Primary outcomes

  1. Urea Kt/V

    Time frame: 9 hours

Secondary outcomes

  1. Creatinine clearance

    Time frame: 9 hours

  2. Patient symptoms

    Time frame: 9 hours

07

Study locations

1 site
  • Herlev Hospital
    Herlev, 2880, Denmark
08

References and documents

Publications

  • 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. PubMed 23136214 ↗
  • 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. PubMed 25896788 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01267760
Lead sponsor
Herlev Hospital
Collaborators
Flexdialysis ApS
Responsible party
James heaf (chief physician, Herlev Hospital) — Principal investigator
First posted
Dec 28, 2010
Start date
Mar 2011
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jul 9, 2013

Study contacts

James G Heaf, MD DMSc
principal investigator · Herlev Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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