Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    50
  • sponsor
    Oslo University Hospital
Updated on 18 September 2021

Summary

Renal transplant recipients are followed as out patients at the transplant center for about 8 weeks after surgery. Between 1-2 weeks after surgery, 50 standard immunological patients will be randomized (1:1) to either follow standard of care (SOC) or having every second poli clinical visit without entering the hospital HBM; Home Based Monitoring). They are to take a capillary finger-prick blood sample themselves, send it to the laboratory for analysis and then they will get a telecom follow-up that day from their transplant physician. Outcome is no difference with regards to being able to follow the randomized follow-up procedure.

Description

Renal transplant recipients are followed as out patients at the transplant center for about 8 weeks after surgery. Between 1-2 weeks after surgery, 50 standard immunological patients (i.e. first, kidney (only) transplants, no donors specific antibodies (DSA), panel reactive antibodies (PRA), ABO blood type compatible transplant) will be randomized (1:1) to either follow standard of care (SOC) or having every second poli clinical visit without entering the hospital HBM; Home Based Monitoring). They are to take a capillary finger-prick blood sample themselves and send it to the laboratory for analysis (creatinine, hemoglobin, tacrolimus and mycophenolate) and then they will get a telecom follow-up that day from their transplant physician. Outcome is no difference with regards to being able to follow the randomized follow-up procedure without having acute rejection episodes and no need for extra ou-patients visits for any reason. End of study is week 7-8 after transplantation.

Details
Condition Kidney Transplant Failure and Rejection
Treatment Standard follow-up, Home-based monitoring
Clinical Study IdentifierNCT04369612
SponsorOslo University Hospital
Last Modified on18 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Kidney only transplant
Immunosuppressive therapy With at least one of; tacrolimus, cyclosporine, everolimus, sirolimus, mycophenolate
Standard immunological risk; no DSA, no PRA, not ABO-incompatible transplant
Age above 18 years
Followed at Oslo University Hospital-Rikshospitalet transplant center
Written informed consent

Exclusion Criteria

Pregnant or breast feeding female recipients
Ongoing acute rejection episodes at time of inclusion
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