Immunosuppression Reduction in Failed Allograft Guided by cfDNA

Kidney Transplant; Complications Clinical Trial

Official title:

Immunosuppression Reduction in Failed Allograft Guided by cfDNA

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04560582
• Other study ID #: NEPH-2018-27080
• Status: Withdrawn
• Start date: September 22, 2022
• Est. completion date: October 2023

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 17 years or younger

• cPRA at entrance of 100%

• Primary non-function of the allograft

• Multi-organ transplant

Related Conditions & MeSH terms

• Kidney Transplant Failure
• Kidney Transplant Rejection
• Kidney Transplant; Complications

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cPRA Concentrations	Outcome is reported as the serum concentration of calculated Panel Reactive Antibody (cPRA) at baseline.	1 day
Primary	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.	up to 24 weeks
Secondary	Incidence of Need for Transfusion	Outcome is reported as the percent of participants who require transfusion.	24 weeks
Secondary	Incidence of Need for Methylprednisolone and Allograft Nephrectomy	Outcome is reported as the percent of participants who require methylprednisolone and allograft nephrectomy	24 weeks
Secondary	Incidence of ESA Dose	Outcome is reported as the percent of participants who require a erythropoesis stimulating agent (ESA) dose.	24 weeks
Secondary	Incidence of Allograft Tenderness	Outcome is reported as the percent of participants who experience allograft tenderness.	24 weeks
Secondary	Incidence of Gross Hematuria	Outcome is reported as the percent of participants who experience gross hematuria.	24 weeks