Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples (HBM-KTx)

University of Oslo (UIO)

Status: Enrolling

Conditions: Kidney Transplant Failure and Rejection

Treatments: Procedure: Home-based monitoring; Procedure: Standard follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT04369612

134787

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

Standard follow-up after kidney transplantation during the first 7-8 post-transplant weeks

Treatment:

Procedure: Standard follow-up

Home-based monitoring

Experimental group

Description:

Every second visit will be performed without patients actually visiting the hospital. They take a capillary blood sample themselves, send it to the lab and get a telecom follow-up by treating physician the same day.

Treatment:

Procedure: Home-based monitoring