Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-28

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Transplant Failure and Rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two Groups, randomized 1:1, to a) Standard of care and b) home-based monitoring. Followed between 1-2 to 7-8 weeks after transplantation

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard of care

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

Group Type ACTIVE_COMPARATOR

Standard follow-up

Intervention Type PROCEDURE

Standard post-transplant follow-up

Home-based monitoring

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.

Group Type EXPERIMENTAL

Home-based monitoring

Intervention Type PROCEDURE

Patients take capillary blood sample by finger-prick and send to lab for analyses. Telecom follow-up that day by treating physician

Interventions

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Standard follow-up

Standard post-transplant follow-up

Intervention Type PROCEDURE

Home-based monitoring

Patients take capillary blood sample by finger-prick and send to lab for analyses. Telecom follow-up that day by treating physician

Intervention Type PROCEDURE

Eligibility Criteria

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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