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Immunosuppression Reduction in Failed Allograft Guided by cfDNA

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ClinicalTrials.gov Identifier: NCT04560582
Recruitment Status : Not yet recruiting
First Posted : September 23, 2020
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief 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.

Condition or disease Intervention/treatment
Kidney Transplant; Complications Kidney Transplant Rejection Kidney Transplant Failure Procedure: Blood Draw

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunosuppression Reduction in Failed Allograft Guided by cfDNA
Estimated Study Start Date : May 1, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Kidney Transplant Patients with Failed Allograft
All participants are assigned to a single cohort of kidney transplant patients with failed allograft requiring dialysis.
Procedure: Blood Draw
Participants will have blood drawn for analysis at baseline and every 4 weeks for a total of 7 blood draws over 24 weeks.




Primary Outcome Measures :
  1. cPRA Concentrations [ Time Frame: 1 day ]
    Outcome is reported as the serum concentration of calculated Panel Reactive Antibody (cPRA) at baseline.

  2. 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.


Secondary Outcome Measures :
  1. Incidence of Need for Transfusion [ Time Frame: 24 weeks ]
    Outcome is reported as the percent of participants who require transfusion.

  2. Incidence of Need for Methylprednisolone and Allograft Nephrectomy [ Time Frame: 24 weeks ]
    Outcome is reported as the percent of participants who require methylprednisolone and allograft nephrectomy

  3. Incidence of ESA Dose [ Time Frame: 24 weeks ]
    Outcome is reported as the percent of participants who require a erythropoesis stimulating agent (ESA) dose.

  4. Incidence of Allograft Tenderness [ Time Frame: 24 weeks ]
    Outcome is reported as the percent of participants who experience allograft tenderness.

  5. Incidence of Gross Hematuria [ Time Frame: 24 weeks ]
    Outcome is reported as the percent of participants who experience gross hematuria.


Biospecimen Retention:   Samples With DNA
Specimens will be stored by study code. All study data will be associated with the specimen through the study code link.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • Failed allograft requiring dialysis
  • Urine output less than 500 cc/day
  • No living donor available for re-transplant option or anticipated deceased donor within the next 12 months

Exclusion Criteria:

- cPRA at entrance of 100%


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560582


Contacts
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Contact: Samy Riad, MD 612-624-9444 riad005@umn.edu
Contact: Ghislaine Feussom 612-626-3636 feuss001@umn.edu

Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Samy Riad, MD University of Minenesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04560582    
Other Study ID Numbers: NEPH-2018-27080
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No