Sertraline Effect in Uremic Pruritis

December 12, 2022 updated by: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

Effectiveness of Sertraline in Alleviating Uremic Pruritis in Hemodialysis Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21526
        • Faculty of Medicine, Aexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in uremic pruritis intensity
Time Frame: 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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: Sherif aziz Zaki, MD, Professor
  • Study Chair: Iman ezzat El Gohary, MD, Professor
  • Study Chair: Heidi Hesham Abd El Hamid, MBBCh, Resident

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Estimate)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sertraline and uremic pruritis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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