Renal Transplant Failure and RejectionNCT05753488
The Effect of Biomarkers of Inflammation on Graft Function in Kidney Transplantation
An observational study of Renal Transplant Failure and Rejection and Inflammation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the relationship of inflammation markers with postoperative graft function and mortality in patients undergoing kidney transplantation. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Transplant Failure and Rejection, Inflammation
- What is being tested?
- graft function
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2023to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients underwent renal transplantation
Who may be able to join
- patients underwent renal transplantation
Who cannot join
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Biomarkers of Inflammation on Graft Function
The aim of the study was to investigate the relationship of inflammation markers with postoperative graft function and mortality in patients undergoing kidney transplantation.
- Being tested
- graft function
- Medical subject headings
- Rejection, Psychology, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
graft functionDiagnostic test
renal transplantation
| Study group | Role | What they receive |
|---|---|---|
| ınflammation | Not described Receives: Diagnostic Test: graft function | |
| non inflammation | Not described Receives: Diagnostic Test: graft function |
What is being measured
The primary outcome is the main question the study is designed to answer.
RDW
Red Cell Distribution Width
Measured: baseline
PNI
prognostic nutrition index (PNI) calculated as 10 × serum albumin (g/dl) + 0.005 × total lymphocyte count (per mm3)
Measured: baseline
De Ritis
De Ritis described the ratio between the serum levels of aspartate transaminase (AST) and alanine transaminase (ALT)
Measured: baseline
graft function
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant Failure and RejectionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ismail aytaç, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753488
- Sponsor's protocol ID
- E1-23-3250
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Biomarkers of Inflammation on Graft Function
- ClinicalTrials.gov ID
- NCT05753488
- Acronym / sponsor ID
- E1-23-3250
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 3 Mar 2023 (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 was to investigate the relationship of inflammation markers with postoperative graft function and mortality in patients undergoing kidney transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ınflammation | – | Diagnostic Test: graft function |
| non inflammation | – | Diagnostic Test: graft function |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients underwent renal transplantation
Key inclusion criteria (1 listed)
- patients underwent renal transplantation
Key exclusion criteria (1 listed)
- patient refusal
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 |
|---|---|---|
| graft functionrenal transplantation | Diagnostic test | non inflammation, ınflammation |
Primary outcome
RDW
Time frame: baseline
Red Cell Distribution Width
PNI
Time frame: baseline
prognostic nutrition index (PNI) calculated as 10 × serum albumin (g/dl) + 0.005 × total lymphocyte count (per mm3)
De Ritis
Time frame: baseline
De Ritis described the ratio between the serum levels of aspartate transaminase (AST) and alanine transaminase (ALT)
graft function
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant Failure and Rejection and Inflammation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 1 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: status not confirmed, as of the sponsor's last update on 3 Mar 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RDW (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2023.