AzTrials
AzTrials

End Stage Renal Disease on DialysisPhase 2IPUF-HDNCT04603014

Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients

A Phase 2 study testing Interdialytic peritoneal ultrafiltration with 10% dextrose solution in people with End Stage Renal Disease on Dialysis and Hemodialysis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Sodium accumulates in the tissues of patients with kidney disease and impairs survival. Three-times weekly, standard hemodialysis alone cannot remove excess sodium efficiently. A sample of 10 chronic hemodialysis patients will undergo a 5-week, pilot, interventional study to test the efficacy of additional sodium… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Interdialytic peritoneal ultrafiltration with 10% dextrose solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
1 Jan 2021to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least one of the following:
  • Average per-session interdialytic weight gain ≥ 4.0 % of their dry weight in the last month;
  • Inability to consistently achieve dry weight with the current treatment schedule;
  • Need for additional HD treatments to achieve prescribed dry weight.
  • Weekly HD sessions - up to three times/week
  • Age ≥18 years
  • Willing and able to give informed consent

Who cannot join

  • Contraindications to peritoneal dialysis
  • Contraindications to MRI
  • Uncontrolled diabetes mellitus
  • Active infections
  • Non-compliance to hemodialysis prescription
  • Pre-study serum sodium < 130 mmol/L

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

Other trials in Canada

About this study

Official title: Initial Feasibility Pilot Study of Interdialytic Peritoneal Ultrafiltration to Manage Volume Status in Hemodialysis Patients

Sodium accumulates in the tissues of patients with kidney disease and impairs survival. Three-times weekly, standard hemodialysis alone cannot remove excess sodium efficiently. A sample of 10 chronic hemodialysis patients will undergo a 5-week, pilot, interventional study to test the efficacy of additional sodium removal in-between hemodialysis sessions, twice per week, for three weeks. Tissue sodium removal will be achieved with peritoneal dialysis after the surgical insertion of a peritoneal dialysis catheter. Tissue sodium removal will be assessed at the beginning and at the end of the study with sodium magnetic resonance imaging of a peripheral limb (leg). Patients will also undergo monitoring for symptoms and blood pressure throughout the study to assess the safety of this procedure.

Read the detailed description

Hypothesis: Interdialytic peritoneal ultrafiltration (iPUF) via Tenckhoff peritoneal dialysis catheter using 10% Dextrose infusate is feasible and provides effective volume management and sodium removal in prevalent HD patients.

Overview: This is a prospective, interventional pilot study from the London Health Sciences Centre (LHSC) prevalent HD population. Study patients will undergo the surgical implantation of a Tenckhoff peritoneal dialysis catheter before study start. After the successful insertion of the Tenckhoff catheter, study patients will enter a run-in phase, where their residual renal function, volume, hemodynamic and cardiac status during HD will be assessed. During the following weeks (intervention weeks 1, 2, 3), study patients will receive in-center iPUF intervention, consisting of peritoneal infusate instillation of a 10% dextrose solution via a Tenckhoff catheter, immediately after the first two HD sessions of the week (Monday, Wednesday); the infusate will be dwelling in the study patient's peritoneal cavity for 2 hours, at the end of which the solution will be drained and the patient sent home. Study patients will be monitored during infusate administration and for the first four hours thereafter. The study intervention will be discontinued at the beginning of week 5 (Wash-out); during week 5 and the first HD session of week 6, study patients will be monitored to observe potential residual effects of the iPUF intervention.

Being tested
Interdialytic peritoneal ultrafiltration with 10% dextrose solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interdialytic peritoneal ultrafiltration with 10% dextrose solutionCombination product

    Interdialytic peritoneal ultrafiltration with incremental doses of a 10% dextrose solution, after hemodialysis twice weekly for three consecutive weeks

Study groups in NCT04603014
Study groupRoleWhat they receive
Interdialytic peritoneal ultrafiltrationExperimentalWill receive incremental interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks
Receives: Combination Product: Interdialytic peritoneal ultrafiltration with 10% dextrose solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skin sodium concentration

    Skin sodium concentration at the end of week 4 as measured by sodium-23 magnetic resonance imaging of the leg.

    Measured: End of week 4

  2. Adverse events

    Completion of the iPUF treatment without adverse events

    Measured: iPUF interventions on Week 2, 3 and 4

Secondary outcomes (9)

  1. Interdialytic weight gain

    Difference in interdialytic weight gain at run-in week vs end of intervention, vs wash-out

    Measured: week 1 vs 4, week 1 vs 5-6

  2. Total weekly sodium removal with interdialytic peritoneal ultrafiltration

    Total weekly sodium removal with peritoneal dialysis in intervention weeks

    Measured: week 2, 3, 4

  3. Total volume of fluid removed with interdialytic peritoneal ultrafiltration

    Total volume of fluid removed with peritoneal dialysis in intervention weeks

    Measured: week 2, 3, 4

  4. Home blood pressure

    Changes in home blood pressure at baseline vs end of intervention and vs washout

    Measured: week 1 vs week 4, week 1 vs 5-6

  5. Mean intradialytic hemodynamics

    Changes in mean intradialytic hemodynamic monitor parameters, as measured with Finometer and CVInsight

    Measured: week 1 vs 4, week 1 vs 6

  6. Regional wall motion abnormalities

    Changes in Regional Wall Motion Abnormalities (echocardiography) at peak-stress hemodialysis

    Measured: week 1 vs 4, week 1 vs 6

  7. Symptoms

    Changes in symptoms as measured with the London Evaluation of Illness questionnaire

    Measured: week 1 vs 4, week 1 vs 6

  8. Infusion pain

    Infusion pain as measured with 0-10 visual analog scale

    Measured: Through study completion, average of all study treatments

  9. Changes in serum sodium

    Post-iPUF change in serum sodium

    Measured: Through study completion, average of all study treatments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start1 Jan 2021
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04603014
Sponsor's protocol ID
115423
Acronym
IPUF-HD
Status last verified
Apr 2026
First submitted
13 Oct 2020
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Flythe JE, Curhan GC, Brunelli SM. Disentangling the ultrafiltration rate-mortality association: the respective roles of session length and weight gain. Clin J Am Soc Nephrol. 2013 Jul;8(7):1151-61. doi: 10.2215/CJN.09460912. Epub 2013 Mar 14.

    PubMed 23493384

  • Assimon MM, Wang L, Flythe JE. Failed Target Weight Achievement Associates with Short-Term Hospital Encounters among Individuals Receiving Maintenance Hemodialysis. J Am Soc Nephrol. 2018 Aug;29(8):2178-2188. doi: 10.1681/ASN.2018010004. Epub 2018 May 23.

    PubMed 29793962

  • Ramdeen G, Tzamaloukas AH, Malhotra D, Leger A, Murata GH. Estimates of interdialytic sodium and water intake based on the balance principle: differences between nondiabetic and diabetic subjects on hemodialysis. ASAIO J. 1998 Nov-Dec;44(6):812-7. doi: 10.1097/00002480-199811000-00009.

    PubMed 9831090

  • Titze J, Lang R, Ilies C, Schwind KH, Kirsch KA, Dietsch P, Luft FC, Hilgers KF. Osmotically inactive skin Na+ storage in rats. Am J Physiol Renal Physiol. 2003 Dec;285(6):F1108-17. doi: 10.1152/ajprenal.00200.2003. Epub 2003 Jul 29.

    PubMed 12888617

  • Kopp C, Linz P, Wachsmuth L, Dahlmann A, Horbach T, Schofl C, Renz W, Santoro D, Niendorf T, Muller DN, Neininger M, Cavallaro A, Eckardt KU, Schmieder RE, Luft FC, Uder M, Titze J. (23)Na magnetic resonance imaging of tissue sodium. Hypertension. 2012 Jan;59(1):167-72. doi: 10.1161/HYPERTENSIONAHA.111.183517. Epub 2011 Dec 5.

    PubMed 22146510

  • Machnik A, Neuhofer W, Jantsch J, Dahlmann A, Tammela T, Machura K, Park JK, Beck FX, Muller DN, Derer W, Goss J, Ziomber A, Dietsch P, Wagner H, van Rooijen N, Kurtz A, Hilgers KF, Alitalo K, Eckardt KU, Luft FC, Kerjaschki D, Titze J. Macrophages regulate salt-dependent volume and blood pressure by a vascular endothelial growth factor-C-dependent buffering mechanism. Nat Med. 2009 May;15(5):545-52. doi: 10.1038/nm.1960. Epub 2009 May 3.

    PubMed 19412173

  • Wenstedt EFE, Olde Engberink RHG, Vogt L. Sodium Handling by the Blood Vessel Wall: Critical for Hypertension Development. Hypertension. 2018 Jun;71(6):990-996. doi: 10.1161/HYPERTENSIONAHA.118.10211. Epub 2018 Apr 16. No abstract available.

    PubMed 29661837

  • Qirjazi E, Salerno FR, Akbari A, Hur L, Penny J, Scholl T, McIntyre CW. Tissue sodium concentrations in chronic kidney disease and dialysis patients by lower leg sodium-23 magnetic resonance imaging. Nephrol Dial Transplant. 2020 Apr 6:gfaa036. doi: 10.1093/ndt/gfaa036. Online ahead of print.

    PubMed 32252091

  • Canaud B, Kooman J, Selby NM, Taal M, Francis S, Kopperschmidt P, Maierhofer A, Kotanko P, Titze J. Sodium and water handling during hemodialysis: new pathophysiologic insights and management approaches for improving outcomes in end-stage kidney disease. Kidney Int. 2019 Feb;95(2):296-309. doi: 10.1016/j.kint.2018.09.024.

    PubMed 30665570

  • Dahlmann A, Dorfelt K, Eicher F, Linz P, Kopp C, Mossinger I, Horn S, Buschges-Seraphin B, Wabel P, Hammon M, Cavallaro A, Eckardt KU, Kotanko P, Levin NW, Johannes B, Uder M, Luft FC, Muller DN, Titze JM. Magnetic resonance-determined sodium removal from tissue stores in hemodialysis patients. Kidney Int. 2015 Feb;87(2):434-41. doi: 10.1038/ki.2014.269. Epub 2014 Aug 6.

    PubMed 25100048

  • Santos SF, Peixoto AJ. Sodium balance in maintenance hemodialysis. Semin Dial. 2010 Nov-Dec;23(6):549-55. doi: 10.1111/j.1525-139X.2010.00794.x.

    PubMed 21175831

  • Obi Y, Rhee CM, Mathew AT, Shah G, Streja E, Brunelli SM, Kovesdy CP, Mehrotra R, Kalantar-Zadeh K. Residual Kidney Function Decline and Mortality in Incident Hemodialysis Patients. J Am Soc Nephrol. 2016 Dec;27(12):3758-3768. doi: 10.1681/ASN.2015101142. Epub 2016 May 11.

    PubMed 27169576

  • Kawanishi H, Hashimoto Y, Nakamoto H, Nakayama M, Tranaeus A. Combination therapy with peritoneal dialysis and hemodialysis. Perit Dial Int. 2006 Mar-Apr;26(2):150-4. No abstract available.

    PubMed 16623416

  • McIntyre CW. Bimodal dialysis: an integrated approach to renal replacement therapy. Perit Dial Int. 2004 Nov-Dec;24(6):547-53.

    PubMed 15559484

  • Sriperumbuduri S, Biyani M, Brown PA, McCormick BB. Retrospective study of patients on hybrid dialysis: Single-center data from North America. Perit Dial Int. 2020 Mar;40(2):224-226. doi: 10.1177/0896860819887284. Epub 2020 Jan 17.

    PubMed 32063198

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interdialytic peritoneal ultrafiltration with 10% dextrose solution in people with End Stage Renal Disease on Dialysis and Hemodialysis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin sodium concentration (time frame: End of week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04603014, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in