Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients

NCT04603014 | Active Not Recruiting Phase 2

• 1 other identifier: 115423
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

End Stage Renal Disease on Dialysis; Hemodialysis; Peritoneal Dialysis; Nonosmotic Sodium Storage

Outcome Measures

Primary Outcomes (2)

• Skin sodium concentration

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

  End of week 4

• Adverse events

  Completion of the iPUF treatment without adverse events

  iPUF interventions on Week 2, 3 and 4

Secondary Outcomes (9)

• Interdialytic weight gain

  week 1 vs 4, week 1 vs 5-6

• Total weekly sodium removal with interdialytic peritoneal ultrafiltration

  week 2, 3, 4

• Total volume of fluid removed with interdialytic peritoneal ultrafiltration

  week 2, 3, 4

• Home blood pressure

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

• Mean intradialytic hemodynamics

  week 1 vs 4, week 1 vs 6

Study Arms (1)

Interdialytic peritoneal ultrafiltration

EXPERIMENTAL

Will receive incremental interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks

Combination Product: Interdialytic peritoneal ultrafiltration with 10% dextrose solution

Interventions

Interdialytic peritoneal ultrafiltration with 10% dextrose solution COMBINATION_PRODUCT

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

Interdialytic peritoneal ultrafiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sequana Medical N.V.: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (22)

• 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.

  PMID: 23493384 BACKGROUND

• 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.

  PMID: 29793962 BACKGROUND

• 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.

  PMID: 9831090 BACKGROUND

• 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.

  PMID: 12888617 BACKGROUND

• 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.

  PMID: 22146510 BACKGROUND

• 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.

  PMID: 19412173 BACKGROUND

• 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.

  PMID: 29661837 BACKGROUND

• 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.

  PMID: 32252091 BACKGROUND

• 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.

  PMID: 30665570 BACKGROUND

• 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.

  PMID: 25100048 BACKGROUND

• 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.

  PMID: 21175831 BACKGROUND

• 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.

  PMID: 27169576 BACKGROUND

• 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.

  PMID: 16623416 BACKGROUND

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

  PMID: 15559484 BACKGROUND

• 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.

  PMID: 32063198 BACKGROUND

• Banshodani M, Kawanishi H, Moriishi M, Shintaku S, Tsuchiya S. Association between Dialysis Modality and Cardiovascular Diseases: A Comparison between Peritoneal Dialysis and Hemodialysis. Blood Purif. 2020;49(3):302-309. doi: 10.1159/000504040. Epub 2019 Dec 18.

  PMID: 31851981 BACKGROUND

• Kanda R, Io H, Nakata J, Makita Y, Sasaki Y, Matsumoto M, Wakabayashi K, Tomino Y, Suzuki Y. Evaluation of Long-Term Combination Therapy With Peritoneal Dialysis and Hemodialysis. Ther Apher Dial. 2017 Apr;21(2):180-184. doi: 10.1111/1744-9987.12517. Epub 2017 Feb 10.

  PMID: 28185405 BACKGROUND

• Rao VS, Turner JM, Griffin M, Mahoney D, Asher J, Jeon S, Yoo PS, Boutagy N, Feher A, Sinusas A, Wilson FP, Finkelstein F, Testani JM. First-in-Human Experience With Peritoneal Direct Sodium Removal Using a Zero-Sodium Solution: A New Candidate Therapy for Volume Overload. Circulation. 2020 Mar 31;141(13):1043-1053. doi: 10.1161/CIRCULATIONAHA.119.043062. Epub 2020 Jan 8.

  PMID: 31910658 BACKGROUND

• Quiroga IM, Baboo R, Lord RH, Darby CR. Tenckhoff catheters post-renal transplantation: the 'pull' technique? Nephrol Dial Transplant. 2001 Oct;16(10):2079-81. doi: 10.1093/ndt/16.10.2079.

  PMID: 11572901 BACKGROUND

• Grieff M, Mamo E, Scroggins G, Kurchin A. The 'Pull' Technique for Removal of Peritoneal Dialysis Catheters: A Call for Re-Evaluation of Practice Standards. Perit Dial Int. 2017 Mar-Apr;37(2):225-229. doi: 10.3747/pdi.2016.00152.

  PMID: 28360368 BACKGROUND

• Quiroga I, Reddy SP, Bhattacharjya S, Darby CR. Tenckhoff catheters: the pull technique. Nephrol Dial Transplant. 2003 Aug;18(8):1682. doi: 10.1093/ndt/gfg173. No abstract available.

  PMID: 12897121 BACKGROUND

• McIntyre CW. Update on Hemodialysis-Induced Multiorgan Ischemia: Brains and Beyond. J Am Soc Nephrol. 2024 May 1;35(5):653-664. doi: 10.1681/ASN.0000000000000299. Epub 2024 Jan 26.

  PMID: 38273436 DERIVED

Study Officials

• Christopher W. McIntyre, MD, PhD

  Lawson Research Institute

  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: Professor of Medicine, Medical Biophysics and Pediatrics, School of Medicine and Dentistry, Western University; Director of The Kidney Clinical Research Unit, London Health Sciences Centre, London, ON, Canada

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 26, 2020
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)