Frailty Among Renal Transplant Recipients and Relation to Chronic Allograft Dysfunction

NCT ID: NCT07181096

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-01-15

Brief Summary

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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.

Detailed Description

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With respect to correlates of frailty, although higher comorbidity burden is also a risk factor for frailty among KT candidates, frailty can also occur in the setting of lower comorbidity burdens. Diabetes and serum albumin concentration are also associated with frailty among prevalent dialysis patients.

In addition, individuals with CKD and ESKD who are frail are also more likely to have cognitive impairment and sarcopenia, or low muscle mass, than their non-frail counterparts

Conditions

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Frailty Renal Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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renal transplant patients

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.

Group Type EXPERIMENTAL

assessment of frailty

Intervention Type DIAGNOSTIC_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.

Interventions

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assessment of frailty

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Renal transplanted patients with GFR more than 30

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed mamdouh Elsayed, MD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

salah saed naga, MD

Role: PRINCIPAL_INVESTIGATOR

professor

hala seddik elwakil, MD

Role: STUDY_CHAIR

professor

dalia ezzat saleh, MBBCH

Role: STUDY_CHAIR

resident

Locations

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Faculty of Medicine, Aexandria University

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed mamdouh Elsayed, MD

Role: CONTACT

00201068055103

Facility Contacts

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mohamed mamdouh elsayed, MD

Role: primary

00201068055103

References

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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.

Reference Type BACKGROUND
PMID: 30879429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36325001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34036171 (View on PubMed)

Other Identifiers

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frailty in renal transplant

Identifier Type: -

Identifier Source: org_study_id

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