FrailtyNCT07181096
Frailty Among Renal Transplant Recipients and Relation to Chronic Allograft Dysfunction
A study testing assessment of frailty in people with Frailty and Renal Transplant, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty, Renal Transplant
- What is being tested?
- assessment of frailty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal transplanted patients with GFR more than 30
Who cannot join
- Mentally or physically unfit patients.
- Amputation of lower limb.
- Active neoplasia, chronic liver disease, previous immunological disease.
- Psychiatric disorders.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Aexandria University
Alexandria, 21526
mohamed mamdouh elsayed, MD, 00201068055103, dr_mohamedmamdouh87@yahoo.com
About this study
Official title: Study of Frailty Among Renal Transplant Recipients, Its Relation to Chronic Renal Allograft Dysfunction
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.
Read the detailed description
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
- Frailty, Renal Transplant
- Being tested
- assessment of frailty
- Keywords
- Frailty, renal transplant recipient, chronic allograft dysfunction
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- Assessment of frailty by Clinical Frailty Scale.
- Assessment of nutritional status using Patient Generated Subjective Global Assessment (PG-SGA).
- Comorbidity assessment using Charlson comorbidity score.
- Six minutes walk test.
- Muscle strength assessment using hand grip strength (HGS) dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: assessment of frailty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of frailty
by Clinical Frailty Scale.
Measured: 30 days
Secondary outcomes (3)
Assessment of nutritional status
using Patient Generated Subjective Global Assessment (PG-SGA)
Measured: 30 days
Comorbidity assessment
using Charlson comorbidity score
Measured: 30 days
Muscle strength assessment
using hand grip strength (HGS) dynamometer.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start15 Jul 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- Mohamed mamdouh Elsayed, MD, Principal investigator, Associate professorsalah saed naga, MD, Principal investigator, professorhala seddik elwakil, MD, Study chair, professordalia ezzat saleh, MBBCH, Study chair, resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181096
- Sponsor's protocol ID
- frailty in renal transplant
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30879429Alfieri 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.
PubMed 36325001Quint 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.
PubMed 34036171
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Frailty Among Renal Transplant Recipients, Its Relation to Chronic Renal Allograft Dysfunction
- ClinicalTrials.gov ID
- NCT07181096
- Acronym / sponsor ID
- frailty in renal transplant
- Conditions
- Frailty, Renal Transplant
- Keywords
- Frailty, renal transplant recipient, chronic allograft dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| renal transplant patients | Experimental | Diagnostic Test: assessment of frailtypatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Renal transplanted patients with GFR more than 30
Key exclusion criteria (5 listed)
- Mentally or physically unfit patients.
- Amputation of lower limb.
- Active neoplasia, chronic liver disease, previous immunological disease.
- Psychiatric disorders.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of frailtyThis 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. | Diagnostic test | renal transplant patients |
Primary outcome
Assessment of frailty
Time frame: 30 days
by Clinical Frailty Scale.
3 secondary outcomes
Assessment of nutritional status
Time frame: 30 days
Comorbidity assessment
Time frame: 30 days
Muscle strength assessment
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Background: PubMed 30879429Lorenz 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.
- Background: PubMed 36325001Alfieri 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.
- Background: PubMed 34036171Quint 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.
- Individual participant dataSharing planned: Undecided
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed mamdouh Elsayed, MD principal investigator
Associate professor
salah saed naga, MD principal investigator
professor
hala seddik elwakil, MD study chair
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment of frailty in people with Frailty and Renal Transplant, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed mamdouh Elsayed, MD (00201068055103, dr_mohamedmamdouh87@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of frailty (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07181096, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.