Kidney Transplant; ComplicationsNCT03605264
Biomarkers NGAL, IL 18 as Predictors of Acute Kidney Injury in Renal Transplant Recipients
An observational study of Kidney Transplant; Complications and Acute Kidney Injury, run by Institute of Liver and Biliary Sciences, India.
Trial summary
New markers of AKI including plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) and Interleukin 18(IL-18) may form a biomarker panel that may help predict AKI earlier in the course of disease than creatinine. Biomarkers for renal injury decreases following successful Renal transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant; Complications, Acute Kidney Injury
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 15 Feb 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is patients undergoing renal transplantation
Who may be able to join
- Patients undergoing renal transplant surgery
Who cannot join
- Patients with sepsis
- Patients diagnosed with malignancy
- Patients on immunosuppressants for other indications
- Denial to participation
- Patients undergoing re-transplantation
- Pregnant Women
About this study
Official title: Biomarkers Neutrophil Gelatinase Associated Lipocalin, Interleukin 18 as Predictors of Acute Kidney Injury in Renal Transplant Recipients A Pilot Study
New markers of AKI including plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) and Interleukin 18(IL-18) may form a biomarker panel that may help predict AKI earlier in the course of disease than creatinine.
Biomarkers for renal injury decreases following successful Renal transplantation. The level of decrease in biomarkers, correlates with the renal graft function, and this fall occurs earlier than the fall in creatinine and/or increase in the Urine output. Should graft dysfunction occurs, investigating the fall in biomarkers could provide a window of opportunity for therapeutic interventions and also guide in evaluating the effectiveness of such interventions. NGAL is a 25 kilo Dalton(kDa) ligand-binding protein of the lipocalin family, present in human tissues including kidney. NGAL is induced early in ischemic or nephrotoxic injury to the kidney. It has also been evaluated as a biomarker of acute injury in kidney transplantation. Interleukin (IL)-18 is synthesized as an inactive 23 kDa precursor by several tissues including monocytes, macrophages, and proximal tubular epithelial cells. Urine IL-18 is elevated in patients with acute tubular necrosis and in urinary tract infection, chronic renal insufficiency, and prerenal azotemia.
Delayed graft function and slow graft function are associated with poor graft survival at one year. Early prediction of graft dysfunction could help prognosticate and initiate renoprotective measures. Urine biomarkers including NGAL and IL 18 have shown promise in this regard, but it may be fraught with risk of biomarker dilution, an effect of urinary flow rate on biomarker levels. The investigators hypothesized that plasma NGAL and plasma IL-18 can detect reduced renal graft function in renal transplant recipients within the first 2 postoperative days.
Read the detailed description
Creatinine is widely used as a marker of kidney function. The use of Creatinine has many confounding factors, and it rises only after loss of 50% of renal function. This time lost in rise of serum creatinine gives rise to the risk of missing time window that may be used to prevent progress of Acute Kidney Injury (AKI).
NGAL and IL 18 are a panel of new biomarkers associated with acute kidney injury, and their levels correlate with an improvement of graft function in renal transplant recipients. Precise and early detection of a failing graft can prompt multiple investigations and interventions which may ultimately aid in maintaining the graft.
The serum levels were measured to avoid the dilution effect and output variability of urine samples.
The investigators measure the serum NGAL and IL-18 for the first 2 post-operative days after renal transplantation, and check if the trends correlate with long term graft survival and function.
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Slow Graft Function | Slow Graft function(SGF) is defined as a failure of serum creatinine to fall by 70% at postoperative day 7 after renal transplantation. | |
| Immediate Graft Function | Immediate graft function(IGF) is defined as a fall of serum creatinine of 70% at postoperative day 7 after renal transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slow Graft Function
failure of serum creatinine to fall by 70% at postoperative day 7 after renal transplantation.
Measured: 7 days
Early Graft Loss(EGL)
Early Graft Loss was defined as graft nephrectomy or loss of kidney transplant function resulting in the recipient becoming dialysis dependent within 30 days of kidney transplantation (and never achieving graft function thereafter) or death with a non-functioning graft within 30 days
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 posted30 Jul 2018
- Study start1 Mar 2016
- Primary completion15 Jan 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605264
- Sponsor's protocol ID
- ILBS-Renal Biomarkers-1
- Status last verified
- Aug 2018
- First submitted
- 20 Jul 2018
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers Neutrophil Gelatinase Associated Lipocalin, Interleukin 18 as Predictors of Acute Kidney Injury in Renal Transplant Recipients A Pilot Study
- ClinicalTrials.gov ID
- NCT03605264
- Acronym / sponsor ID
- ILBS-Renal Biomarkers-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 30 Jul 2018 (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.
New markers of AKI including plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) and Interleukin 18(IL-18) may form a biomarker panel that may help predict AKI earlier in the course of disease than creatinine.
Biomarkers for renal injury decreases following successful Renal transplantation. The level of decrease in biomarkers, correlates with the renal graft function, and this fall occurs earlier than the fall in creatinine and/or increase in the Urine output. Should graft dysfunction occurs, investigating the fall in biomarkers could provide a window of opportunity for therapeutic interventions and also guide in evaluating the effectiveness of such interventions. NGAL is a 25 kilo Dalton(kDa) ligand-binding protein of the lipocalin family, present in human tissues including kidney. NGAL is induced early in ischemic or nephrotoxic injury to the kidney. It has also been evaluated as a biomarker of acute injury in kidney transplantation. Interleukin (IL)-18 is synthesized as an inactive 23 kDa precursor by several tissues including monocytes, macrophages, and proximal tubular epithelial cells. Urine IL-18 is elevated in patients with acute tubular necrosis and in urinary tract infection, chronic renal insufficiency, and prerenal azotemia.
Delayed graft function and slow graft function are associated with poor graft survival at one year. Early prediction of graft dysfunction could help prognosticate and initiate renoprotective measures. Urine biomarkers including NGAL and IL 18 have shown promise in this regard, but it may be fraught with risk of biomarker dilution, an effect of urinary flow rate on biomarker levels. The investigators hypothesized that plasma NGAL and plasma IL-18 can detect reduced renal graft function in renal transplant recipients within the first 2 postoperative days.
Detailed description
Creatinine is widely used as a marker of kidney function. The use of Creatinine has many confounding factors, and it rises only after loss of 50% of renal function. This time lost in rise of serum creatinine gives rise to the risk of missing time window that may be used to prevent progress of Acute Kidney Injury (AKI).
NGAL and IL 18 are a panel of new biomarkers associated with acute kidney injury, and their levels correlate with an improvement of graft function in renal transplant recipients. Precise and early detection of a failing graft can prompt multiple investigations and interventions which may ultimately aid in maintaining the graft.
The serum levels were measured to avoid the dilution effect and output variability of urine samples.
The investigators measure the serum NGAL and IL-18 for the first 2 post-operative days after renal transplantation, and check if the trends correlate with long term graft survival and function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow Graft Function | – | –Slow Graft function(SGF) is defined as a failure of serum creatinine to fall by 70% at postoperative day 7 after renal transplantation. |
| Immediate Graft Function | – | –Immediate graft function(IGF) is defined as a fall of serum creatinine of 70% at postoperative day 7 after renal transplantation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients undergoing renal transplantation
Key inclusion criteria (1 listed)
- Patients undergoing renal transplant surgery
Key exclusion criteria (6 listed)
- Patients with sepsis
- Patients diagnosed with malignancy
- Patients on immunosuppressants for other indications
- Denial to participation
- Patients undergoing re-transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Slow Graft Function
Time frame: 7 days
failure of serum creatinine to fall by 70% at postoperative day 7 after renal transplantation.
Early Graft Loss(EGL)
Time frame: 30 days
Early Graft Loss was defined as graft nephrectomy or loss of kidney transplant function resulting in the recipient becoming dialysis dependent within 30 days of kidney transplantation (and never achieving graft function thereafter) or death with a non-functioning graft within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant; Complications and Acute Kidney Injury, run by Institute of Liver and Biliary Sciences, India.
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 6 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: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Slow Graft Function (time frame: 7 days). The study lists 2 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 25 Oct 2021.