Clinical trial NCT06671535: Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
Official title: Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CKD (Chronic Kidney Disease) Stage 5D
Hemodialysis
Pruritis
Keywords: polymethylmethacrylate membranes
CKD-associated pruritis
PMMA membranes
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 5D Elman Itch Scale total score
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: WI-NRS score
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Skindex-16 score
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Itch-MOS score
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: 5D Elman Itch Scale total score
timeFrame: From the end of active treatment to the end of follow-up (4 weeks)
measure: WI-NRS score
timeFrame: From the end of active treatment to the end of follow-up (4 weeks)
measure: Skindex-16 score
timeFrame: From the end of active treatment to the end of follow-up (4 weeks)
measure: Itch-MOS score
timeFrame: From the end of active treatment to the end of follow-up (4 weeks)
measure: C-reactive protein concentration
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Serum ferritin
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Saint Petersburg State University Hospital
Study officials:
References: