Kidney Transplant Failure and Rejection
Conditions
Keywords
capillary sample, finger-prick, home-based monitoring
Brief 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.
Detailed 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.
Interventions
PROCEDUREStandard follow-up
Standard post-transplant follow-up
PROCEDUREHome-based monitoring
Patients take capillary blood sample by finger-prick and send to lab for analyses. Telecom follow-up that day by treating physician
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate | 1-8 weeks post-transplant | Complete follow-up without acute rejection and no need for extra visit of any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extra visits to Control immunosuppressive drug levels | 1-8 weeks post-transplant | Number of extra visits in order to monitoring appropriate drug Levels of immunosuppressive drugs |
Countries
Norway
Contacts
Primary ContactKarsten Midtvedt, MD, PhD
Backup ContactAnders Åsberg, PhD
Outcome results
None listed