Kidney Transplant; ComplicationsNCT04560582
Immunosuppression Reduction in Failed Allograft Guided by cfDNA
An observational study of Kidney Transplant; Complications and Kidney Transplant Rejection, run by University of Minnesota at 1 site in United States.
Trial summary
The optimal timing for immunosuppression tapering for patients with failed kidney transplant is not known. This pilot study would be to correlate rise in cf-DNA and increase in cPRA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Kidney Transplant Rejection, Kidney Transplant Failure
- What is being tested?
- Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2022to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study proposes to recruit adult patients primarily from the inpatient units at UMMC Fairview, or the Renal or Transplant facilities at the Clinics and Surgery Center as attended by the PI and Co-Is. Additional clinics will be recruited from depending on patient population and clinician support.
Who may be able to join
- Failed allograft requiring dialysis
- No living donor available for re-transplant option or anticipated deceased donor within the next 12 months
- Patient to be enrolled prior to 3rd HD (hemodialysis) session or within 1 week of starting peritoneal dialysis
Who cannot join
- 17 years or younger
- cPRA at entrance of 100%
- Primary non-function of the allograft
- Multi-organ transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The optimal timing for immunosuppression tapering for patients with failed kidney transplant is not known. This pilot study would be to correlate rise in cf-DNA and increase in cPRA.
Read the detailed description
This is an observational cohort study collecting data and blood specimens at designated time points. The primary outcome will be comparing the cPRA in patients that have a rise in cf-DNA to those that do not have a rise in cf-DNA. Seondary outcomes include comparison of the combined incidence of need for transfusion, need for methylprednisolone and allograft nephrectomy, ESA dose, allograft tenderness, and gross hematuria.
- Being tested
- Blood Draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
Participants will have blood drawn for analysis at baseline and every 4 weeks for a total of 7 blood draws over 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Kidney Transplant Patients with Failed Allograft | All participants are assigned to a single cohort of kidney transplant patients with failed allograft requiring dialysis. Receives: Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
cPRA Concentrations
Outcome is reported as the serum concentration of calculated Panel Reactive Antibody (cPRA) at baseline.
Measured: 1 day
cf-DNA Concentrations
Outcome is reported as the serum concentration of circulating-free DNA (cfDNA) at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.
Measured: up to 24 weeks
Secondary outcomes (5)
Incidence of Need for Transfusion
Outcome is reported as the percent of participants who require transfusion.
Measured: 24 weeks
Incidence of Need for Methylprednisolone and Allograft Nephrectomy
Outcome is reported as the percent of participants who require methylprednisolone and allograft nephrectomy
Measured: 24 weeks
Incidence of ESA Dose
Outcome is reported as the percent of participants who require a erythropoesis stimulating agent (ESA) dose.
Measured: 24 weeks
Incidence of Allograft Tenderness
Outcome is reported as the percent of participants who experience allograft tenderness.
Measured: 24 weeks
Incidence of Gross Hematuria
Outcome is reported as the percent of participants who experience gross hematuria.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start22 Sep 2022
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: No participants enrolled
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Bregman, MD, Principal investigator, University of Minenesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560582
- Sponsor's protocol ID
- NEPH-2018-27080
- Status last verified
- Nov 2023
- First submitted
- 17 Sep 2020
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosuppression Reduction in Failed Allograft Guided by cfDNA
- ClinicalTrials.gov ID
- NCT04560582
- Acronym / sponsor ID
- NEPH-2018-27080
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 23 Sep 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.
The optimal timing for immunosuppression tapering for patients with failed kidney transplant is not known. This pilot study would be to correlate rise in cf-DNA and increase in cPRA.
Detailed description
This is an observational cohort study collecting data and blood specimens at designated time points. The primary outcome will be comparing the cPRA in patients that have a rise in cf-DNA to those that do not have a rise in cf-DNA. Seondary outcomes include comparison of the combined incidence of need for transfusion, need for methylprednisolone and allograft nephrectomy, ESA dose, allograft tenderness, and gross hematuria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplant Patients with Failed Allograft | – | Procedure: Blood DrawAll participants are assigned to a single cohort of kidney transplant patients with failed allograft requiring dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study proposes to recruit adult patients primarily from the inpatient units at UMMC Fairview, or the Renal or Transplant facilities at the Clinics and Surgery Center as attended by the PI and Co-Is. Additional clinics will be recruited from depending on patient population and clinician support.
Key inclusion criteria (3 listed)
- Failed allograft requiring dialysis
- No living donor available for re-transplant option or anticipated deceased donor within the next 12 months
- Patient to be enrolled prior to 3rd HD (hemodialysis) session or within 1 week of starting peritoneal dialysis
Key exclusion criteria (4 listed)
- 17 years or younger
- cPRA at entrance of 100%
- Primary non-function of the allograft
- Multi-organ transplant
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 |
|---|---|---|
| Blood DrawParticipants will have blood drawn for analysis at baseline and every 4 weeks for a total of 7 blood draws over 24 weeks. | Procedure or surgery | Kidney Transplant Patients with Failed Allograft |
Primary outcome
cPRA Concentrations
Time frame: 1 day
Outcome is reported as the serum concentration of calculated Panel Reactive Antibody (cPRA) at baseline.
cf-DNA Concentrations
Time frame: up to 24 weeks
Outcome is reported as the serum concentration of circulating-free DNA (cfDNA) at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.
5 secondary outcomes
Incidence of Need for Transfusion
Time frame: 24 weeks
Incidence of Need for Methylprednisolone and Allograft Nephrectomy
Time frame: 24 weeks
Incidence of ESA Dose
Time frame: 24 weeks
Incidence of Allograft Tenderness
Time frame: 24 weeks
Incidence of Gross Hematuria
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
Adam Bregman, MD principal investigator
University of Minenesota
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 Kidney Transplant; Complications and Kidney Transplant Rejection, run by University of Minnesota at 1 site 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 3 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: withdrawn, as of the sponsor's last update on 29 Nov 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
cPRA Concentrations (time frame: 1 day). 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 29 Nov 2023.