Sertraline Effect in Uremic Pruritis

Phase 2

Completed

• Conditions: Uremic Pruritis
• Interventions: Drug: placebo; Drug: sertraline

• Registration Number: NCT05341843
• Lead Sponsor: Alexandria University

Brief Summary

This study aims to assess the effect of sertraline on uremic pruritis in patients undergoing regular haemodialysis.

Detailed Description

The reported prevalence of uremic pruritus in adult hemodialysis patients has varied over the years, and some studies suggest the prevalence may be decreasing with more effective dialysis. One of the largest trials (the Dialysis Outcomes and Practice Patterns Study \[DOPPS\]) reported that the prevalence of moderate pruritus remained constant at 18 percent until 2015.

A direct role for proinflammatory T cells and cytokines is suggested by studies that showed higher levels of proinflammatory T helper-1 (TH1) cells, C-reactive protein, interleukin-6, and interleukin-2 levels among hemodialysis patients versus those without pruritus. Also, histamine release from mast cells, other pruritogens and xerosis have been all implicated in the pathogenesis of uremic pruritus.

Less convincing associations have also been made to anemia, male sex, increased beta-2 microglobulin levels, serotype human leukocyte antigen (HLA)-B35, and comorbidities including congestive heart failure and neurologic disease. The risk of uremic pruritis appears to be independent of ethnicity, type of dialysis, and underlying renal disease. No single cause underlying uremic pruritus has been identified. Multiple factors have been associated in observational studies, and supportive therapies that are used to treat uremic pruritus have targeted such factors.

High quality evidence on which to base recommendations for the treatment of uremic pruritus is limited. Many pharmacologic treatments have been proposed for uremic pruritis through different clinical trials. However, the results were quite variable and most of these studies were small uncontrolled trials and hence they were flawed.

Several studies have revealed that the selective serotonin reuptake inhibitors (SSRI) could reduce the severity of pruritus. Sertraline hydrochloride is a selective serotonin reuptake inhibitor which established improvement in itching in patients with cholestatic pruritis. This was supported by Browning et al. (2003) whose study showed 86% of subjects who had been given sertraline for another indication improved considerably with pruritus disappearing in 30% of the subjects.

Generally, most of the previous research has tended to focus on cholestatic pruritis rather than uremic pruritis. Although enough is known to determine a reasonable approach to a patient with uremic pruritus, more research is needed to understand the pathophysiology of this condition and to establish more reliable treatments. Hence, this study is organized in an attempt to find out the effect of sertraline on alleviation of uremic pruritus.

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-22
• Study Start: 2022-05-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-10-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. ≥1 month of maintenance haemodialysis, 3 times per week for 4 hours.
2. Adult patients with ages between 18-80 years.

Exclusion Criteria

1. Primary skin diseases (eczema, psoriasis, allergic dermatitis or drug rash).
2. Peripheral neuropathy, thyroid disease, leukemia, lymphoma, liver disease, Systemic lupus erythematosus or pregnancy.
3. Patients who consumed emollients cream, antihistamine, opioid antagonist, immunosuppressants, cholestyramine, corticosteroids or UVB phototherapy 1 month before study.
4. calcium X phosphorus (Ca X P) >55.0 mg/dl, P >5.5 mg/dl, parathyroid hormone (PTH) >450 pg/ml.
5. Selective serotonin reuptake inhibitors intolerance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	They will receive a placebo in the form of multivitamin tablets similar to the experimental drug with the same regimen, as one tablet /day for 8 weeks
sertraline	sertraline	they will receive sertraline at the intended dose of 50 mg twice daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
change in uremic pruritis intensity	8 weeks	Assessment of pruritis will be done before and after the course of treatment (8 weeks) through the following scores: I) Visual analogue scale (VAS) II) 5D itch scale

Trial Locations

Locations (1)

Faculty of Medicine, Aexandria University; 🇪🇬 Alexandria, Egypt