Sertraline Effect in Uremic Pruritis

Sponsor

Alexandria University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05341843

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Uremic Pruritis	Drug: sertraline Drug: placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This research is a double-blinded randomized multicentric clinical trial in which 50 haemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1. Group A: 25 patients will receive sertraline at the intended dose of 50 mg twice daily for 8 weeks. Group B: 25 patients will receive a placebo.This research is a double-blinded randomized multicentric clinical trial in which 50 haemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1. Group A: 25 patients will receive sertraline at the intended dose of 50 mg twice daily for 8 weeks. Group B: 25 patients will receive a placebo.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

a double blinded study as participants, health care providers as well as the outcome assessor will be unaware about the type of treatment each patient receive.

Primary Purpose:

Treatment

Official Title:

Effectiveness of Sertraline in Alleviating Uremic Pruritis in Hemodialysis Patients

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sertraline they will receive sertraline at the intended dose of 50 mg twice daily for 8 weeks.	Drug: sertraline sertraline at the intended dose of 50 mg twice daily for 8 weeks.
Placebo Comparator: 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	Drug: placebo a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 8 weeks)

Arm

Intervention/Treatment

Experimental: sertraline

they will receive sertraline at the intended dose of 50 mg twice daily for 8 weeks.

Drug: sertraline

sertraline at the intended dose of 50 mg twice daily for 8 weeks.

Placebo Comparator: 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

Drug: placebo

a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 8 weeks)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

450 pg/ml.

Selective serotonin reuptake inhibitors intolerance.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Aexandria University	Alexandria		Egypt	21526

Sponsors and Collaborators

Alexandria University

Investigators

Principal Investigator: Mohamed Mamdouh Elsayed, MD, lecturer
Study Chair: Sherif aziz Zaki, MD, professor
Study Chair: Iman ezzat El Gohary, MD, professor
Study Chair: Heidi Hesham Abd El Hamid, MBBCh, Resident

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Lecturer, Alexandria University

ClinicalTrials.gov Identifier:

NCT05341843

Other Study ID Numbers:

sertraline and uremic pruritis

First Posted:

Apr 22, 2022

Last Update Posted:

Apr 22, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Lecturer, Alexandria University

sertraline, hemodialysis

Additional relevant MeSH terms:

Pruritus

Sertraline

Study Results

No Results Posted as of Apr 22, 2022