NCT05240261

Brief Summary

  1. 1.Asses sleep disorders in CKD patients and those on haemodialysis and related complications ( uncontrolled blood pressure,glomerular filtration rate (GFR) ,proteinuria and psychological disturbance)
  2. 2.Asses effect of hypnotics or sedations for 3 month in improvement those complications after taking treatment .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2022

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

January 2, 2022

Last Update Submit

February 4, 2022

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (3)

  • 1- change in Blood pressure measurement .

    follow up blood pressure ( millimeters of mercury (mm/hg)

    3 months

  • The Quality of Life Scale (QOLS)

    Scores can range from 16 to 112. higher scores indicate better life quality.

    3 months

  • Pittsburgh Sleep Quality Index score (PSQI S).

    Scale 0-21, higher scores indicate worse sleep quality.

    3 months

Secondary Outcomes (2)

  • change in Estimated Glomerular filteration rate.

    3 month

  • proteinuria

    3 months

Study Arms (2)

ESRAD on regular haemodialysis

OTHER

30 ESRD Patients with sleep \< 6 hours on regular haemodialysis . Before and after taking medications for 3 month.

Drug: Quetiapine

CKD patients (predialydsis)

OTHER

30 CKD Patients (predialysis) with sleep \< 6 hours . Before and after taking medications for 3 month.

Drug: Quetiapine

Interventions

QuetiapineDRUG

Quetiapine 25 mg / day

CKD patients (predialydsis)ESRAD on regular haemodialysis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients are between ages 18 and 60 with chronic kidney disease (CKD)( stage III-V) and ESRD Patients on regular haemodialysis \> 6 months.and time of start session of dialysis at 5 pm , thrice weekly .
  • \. Random urine albumin/creatinine ratio of 30 mcg/day or greater (protein in the urine) 3. Patients have ability to complete a sleep survey and must be able to swallow tablets.
  • \. Patients with compensated heart and liver disease. 5. Not on antipsychotic drugs.

You may not qualify if:

  • Patients with history of psychosis.
  • Patients with decompensated heart or liver disease.
  • Patients with diabetes , autoimmune ,thyroid or neurological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Zhang J, Wang C, Gong W, Peng H, Tang Y, Li CC, Zhao W, Ye Z, Lou T. Association between sleep quality and cardiovascular damage in pre-dialysis patients with chronic kidney disease. BMC Nephrol. 2014 Aug 12;15:131. doi: 10.1186/1471-2369-15-131.

    PMID: 25117823BACKGROUND

  • Pengo MF, Ioratti D, Bisogni V, Ravarotto V, Rossi B, Bonfante L, Simioni F, Nalesso F, Maiolino G, Calo LA. In Patients with Chronic Kidney Disease Short Term Blood Pressure Variability is Associated with the Presence and Severity of Sleep Disorders. Kidney Blood Press Res. 2017;42(5):804-815. doi: 10.1159/000484357. Epub 2017 Nov 28.

    PMID: 29212081BACKGROUND

  • Parvan K, Lakdizaji S, Roshangar F, Mostofi M. Quality of sleep and its relationship to quality of life in hemodialysis patients. J Caring Sci. 2013 Nov 30;2(4):295-304. doi: 10.5681/jcs.2013.035. eCollection 2013 Dec.

    PMID: 25276738BACKGROUND

  • Hao Q, Xie M, Zhu L, Dou Y, Dai M, Wu Y, Tang X, Wang Q. Association of sleep duration with chronic kidney disease and proteinuria in adults: a systematic review and dose-response meta-analysis. Int Urol Nephrol. 2020 Jul;52(7):1305-1320. doi: 10.1007/s11255-020-02488-w. Epub 2020 May 16.

    PMID: 32418007BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Mona Abdellatif Aly

CONTACT

00201065610527mona_abdellatif@yahoo.com

Ashraf Mohammed Elshazly

CONTACT

00201069176881

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist of nephrology.

Study Record Dates

First Submitted

January 2, 2022

First Posted

February 15, 2022

Study Start

May 1, 2022

Primary Completion

May 1, 2024

Study Completion

December 31, 2024

Last Updated

February 15, 2022

Record last verified: 2022-02