DGFNCT04414111
Highly Suppressive Treg in Delayed and Slow Graft Function After Kidney Transplantation
An observational study of DGF and Kidney Transplant; Complications, run by St. Louis University at 2 sites in United States.
Trial summary
Delayed/slow graft function is the most common complication after kidney transplantation with an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the incidence of delayed/slow graft… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DGF, Kidney Transplant; Complications
- What is being tested?
- Highly suppressive Treg measurement
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Dec 2020to 31 Jul 2027
- Phase
- Observational
- 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
Study population: Kidney transplant recipients
Who may be able to join
- Adult kidney transplant candidates immediately prior to their kidney transplant surgery
Who cannot join
- < 18 years old
- Active immunosuppressive drug use
- Hepatitis C
- HIV
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loma Linda University Health Transplantation Institute
San Bernardino, California, 92408
Saint Louis University
St Louis, Missouri, 63110
About this study
Official title: Highly Suppressive Treg as a Biomarker for Immunologically Relevant Delayed (DGF) and Slow (SGF) Graft Function After Kidney Transplantation
Delayed/slow graft function is the most common complication after kidney transplantation with an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the incidence of delayed/slow graft function. Delayed/slow graft function, however, is associated with an increased risk of acute rejection and graft failure. There are currently no clinically accepted biomarkers and no specific treatments for delayed/slow graft function. Regulatory T cells are protective in ischemia-reperfusion injury and rejection by suppressing pathologic immune responses. We hypothesize that the pre-transplant measurement of highly suppressive regulatory T cell is an accurate biomarker for delayed/slow graft function and its immunologic consequences. Ultimately, marginal kidney graft allocation could be directed to regulatory T cell-robust recipients and regulatory T cell-directed therapies could decrease marginal kidney graft discards without increasing delayed/slow graft function or impacting outcomes.
- Conditions
- DGF, Kidney Transplant; Complications
- Being tested
- Highly suppressive Treg measurement
- Keywords
- DGF, SGF, Acute rejection, Kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly suppressive Treg measurementDiagnostic test
Circulating highly suppressive Treg measurement
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipient | Kidney transplant recipient Receives: Diagnostic Test: Highly suppressive Treg measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed graft function
Delayed graft function defined as dialysis requirement within the first week after kidney transplant
Measured: 1 week
Slow graft function
Slow graft function defined as a serum creatinine drop of less than 20% in the first 24 hours after kidney transplant
Measured: 24 hours
Secondary outcomes (1)
Acute rejection
Kidney allograft biopsy-proven acute rejection according to Banff criteria
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start7 Dec 2020
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DGFStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- Mid-America Transplant
- Responsible party
- Principal investigator, Henry B. Randall, MD, MBA, FACS, St. Louis University
- Investigators
- Henry Randall, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414111
- Sponsor's protocol ID
- 30530
- Status last verified
- Dec 2025
- First submitted
- 22 May 2020
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highly Suppressive Treg as a Biomarker for Immunologically Relevant Delayed (DGF) and Slow (SGF) Graft Function After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT04414111
- Acronym / sponsor ID
- 30530
- Conditions
- DGF, Kidney Transplant; Complications
- Keywords
- DGF, SGF, Acute rejection, Kidney transplantation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- Mid-America Transplant
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Jun 2020 (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.
Delayed/slow graft function is the most common complication after kidney transplantation with an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the incidence of delayed/slow graft function. Delayed/slow graft function, however, is associated with an increased risk of acute rejection and graft failure. There are currently no clinically accepted biomarkers and no specific treatments for delayed/slow graft function. Regulatory T cells are protective in ischemia-reperfusion injury and rejection by suppressing pathologic immune responses. We hypothesize that the pre-transplant measurement of highly suppressive regulatory T cell is an accurate biomarker for delayed/slow graft function and its immunologic consequences. Ultimately, marginal kidney graft allocation could be directed to regulatory T cell-robust recipients and regulatory T cell-directed therapies could decrease marginal kidney graft discards without increasing delayed/slow graft function or impacting outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipient | – | Diagnostic Test: Highly suppressive Treg measurementKidney transplant recipient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients
Key inclusion criteria (1 listed)
- Adult kidney transplant candidates immediately prior to their kidney transplant surgery
Key exclusion criteria (4 listed)
- < 18 years old
- Active immunosuppressive drug use
- Hepatitis C
- HIV
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 |
|---|---|---|
| Highly suppressive Treg measurementCirculating highly suppressive Treg measurement | Diagnostic test | Kidney transplant recipient |
Primary outcome
Delayed graft function
Time frame: 1 week
Delayed graft function defined as dialysis requirement within the first week after kidney transplant
Slow graft function
Time frame: 24 hours
Slow graft function defined as a serum creatinine drop of less than 20% in the first 24 hours after kidney transplant
1 secondary outcome
Acute rejection
Time frame: 1 year
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 17 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for DGF
Recruiting
The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
Delayed Graft Function, Kidney Transplantation
RecruitingPhase 3
Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation
Delayed Graft Function, DGF
Active, not recruitingObservational study
Does Early Postoperative Fluid Management Affect Functional Delayed Graft Function After Living Donor Kidney Transplantation?
Renal Transplant, DGF
RecruitingPhase 1/2
The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients
Delayed Graft Function, Kidney Transplantation
RecruitingObservational study
MR-proADM as a Early Biomarker for DGF and AR in Kidney and Liver Transplantation
Kidney Transplant; Complications, Liver Transplant; Complications
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.
Henry Randall, MD principal investigator
St. Louis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DGF and Kidney Transplant; Complications, run by St. Louis University at 2 sites in United States.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
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?
Delayed graft function (time frame: 1 week). 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 17 Dec 2025.