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NCT Number: NCT06671535

Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis

This randomized controlled trial aims to evaluate the effect of polymethylmethacrylate dialysis membranes use on the intensity of pruritus in patients with CKD stage 5D receiving maintenance hemodialysis.

The main question it aims to answer is: Does the use of polymethylmethacrylate (PMMA) membranes reduce the intensity of pruritus in dialysis patients?

Researchers will compare PMMA membranes to standard polysulfone-based membranes to see if PMMA works to reduce moderate-to-severe pruritis and pruritis-related quality of life.

Participants will:

* receive maintenance hemodialysis with PMMA or polysulfone membranes for 2 months; * fill in questionnaires about intensity of pruritis and its impact on daily life.

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Key information

Conditions

CKD (Chronic Kidney Disease) Stage 5D Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pruritis Pruritus Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of CKD stage 5D, maintenance hemodialysis not less than 3 months prior screening;
  • Moderate-to-severe pruritis (WI-NRS score ≥ 4);
  • Adequate dialysis dose (spKt/V≥1,4 and/or eKt/V≥1,2);
  • Dialysis treatment regimen: three sessions per week of at least 4 hours duration;
  • Signed informed consent.

Exclusion criteria

  • Presence of active skin disease, cholestasis, severe secondary hyperparathyroidism and other conditions that, in the investigator's opinion, may be responsible for pruritus.
  • Noncompliance of the patient with the protocol (in the investigator's opinion).
  • Use of haemodiafiltration.

Treatment and study plan

Polymethylmethacrylate membrane

Device

A polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property.

polysulfone membranes

Device

Dialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins.

Primary outcomes

  1. 5D Elman Itch Scale total score

    Time frame: From enrollment to the end of treatment at 8 weeks

    The 5-D itch scale is a reliable, multidimensional measure of itching that has been validated in patients with chronic pruritus to able to detect changes over time. This questionnaire was designed to be useful as an outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability and distribution.

Secondary outcomes

  1. WI-NRS score

    Time frame: From enrollment to the end of treatment at 8 weeks

    24-hour Worst Itching Intensity Numerical Rating Scale

  2. Skindex-16 score

    Time frame: From enrollment to the end of treatment at 8 weeks

    Multidimensional tool to assess pruritis

  3. Itch-MOS score

    Time frame: From enrollment to the end of treatment at 8 weeks

    Itch-MOS questionnaire aims to evaluate impact of pruritis on sleep.

  4. 5D Elman Itch Scale total score

    Time frame: From the end of active treatment to the end of follow-up (4 weeks)

  5. WI-NRS score

    Time frame: From the end of active treatment to the end of follow-up (4 weeks)

  6. Skindex-16 score

    Time frame: From the end of active treatment to the end of follow-up (4 weeks)

  7. Itch-MOS score

    Time frame: From the end of active treatment to the end of follow-up (4 weeks)

  8. C-reactive protein concentration

    Time frame: From enrollment to the end of treatment at 8 weeks

  9. Serum ferritin

    Time frame: From enrollment to the end of treatment at 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Ekaterina Parshina, PhD

CONTACT

[email protected]

+7(921)6577372

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2024
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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