NCT07181096

Brief Summary

The aim of the study is to assess prevalence of frailty among renal transplant recipients in Alexandria University Hospitals and to study the relation between frailty and chronic allograft dysfunction.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

July 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 12, 2025

Last Update Submit

September 12, 2025

Conditions

FrailtyRenal Transplant

Keywords

Frailtyrenal transplant recipientchronic allograft dysfunction

Outcome Measures

Primary Outcomes (1)

  • Assessment of frailty

    by Clinical Frailty Scale.

    30 days

Secondary Outcomes (3)

  • Assessment of nutritional status

    30 days

  • Comorbidity assessment

    30 days

  • Muscle strength assessment

    30 days

Study Arms (1)

renal transplant patients

EXPERIMENTAL

patients will be subjected to: 1. Assessment of frailty by Clinical Frailty Scale. 2. Assessment of nutritional status using Patient Generated Subjective Global Assessment (PG-SGA). 3. Comorbidity assessment using Charlson comorbidity score. 4. Six minutes walk test. 5. Muscle strength assessment using hand grip strength (HGS) dynamometer.

Diagnostic Test: assessment of frailty

Interventions

assessment of frailtyDIAGNOSTIC_TEST

This study is a prospective cross-sectional study to assess the prevalence of frailty among 80 cases of renal transplanted patients. Specific tests will include: 1. Assessment of frailty by Clinical Frailty Scale. 2. Assessment of nutritional status using Patient Generated Subjective Global Assessment (PG-SGA). 3. Comorbidity assessment using Charlson comorbidity score. 4. Six minutes walk test. 5. Muscle strength assessment using hand grip strength (HGS) dynamometer.

renal transplant patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal transplanted patients with GFR more than 30

You may not qualify if:

  • Mentally or physically unfit patients.
  • Amputation of lower limb.
  • Active neoplasia, chronic liver disease, previous immunological disease.
  • Psychiatric disorders.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

RECRUITING

Related Publications (3)

  • Lorenz EC, Cosio FG, Bernard SL, Bogard SD, Bjerke BR, Geissler EN, Hanna SW, Kremers WK, Cheng Y, Stegall MD, Cheville AL, LeBrasseur NK. The Relationship Between Frailty and Decreased Physical Performance With Death on the Kidney Transplant Waiting List. Prog Transplant. 2019 Jun;29(2):108-114. doi: 10.1177/1526924819835803. Epub 2019 Mar 17.

    PMID: 30879429BACKGROUND

  • Alfieri C, Malvica S, Cesari M, Vettoretti S, Benedetti M, Cicero E, Miglio R, Caldiroli L, Perna A, Cervesato A, Castellano G. Frailty in kidney transplantation: a review on its evaluation, variation and long-term impact. Clin Kidney J. 2022 May 24;15(11):2020-2026. doi: 10.1093/ckj/sfac149. eCollection 2022 Nov.

    PMID: 36325001BACKGROUND

  • Quint EE, Zogaj D, Banning LBD, Benjamens S, Annema C, Bakker SJL, Nieuwenhuijs-Moeke GJ, Segev DL, McAdams-DeMarco MA, Pol RA. Frailty and Kidney Transplantation: A Systematic Review and Meta-analysis. Transplant Direct. 2021 May 18;7(6):e701. doi: 10.1097/TXD.0000000000001156. eCollection 2021 Jun.

    PMID: 34036171BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed mamdouh Elsayed, MD

    Associate professor

    PRINCIPAL INVESTIGATOR

  • salah saed naga, MD

    professor

    PRINCIPAL INVESTIGATOR

  • hala seddik elwakil, MD

    professor

    STUDY CHAIR

  • dalia ezzat saleh, MBBCH

    resident

    STUDY CHAIR

Central Study Contacts

Mohamed mamdouh Elsayed, MD

CONTACT

00201068055103dr_mohamedmamdouh87@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 18, 2025

Study Start

July 15, 2025

Primary Completion

December 15, 2025

Study Completion

January 15, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations

EG(1)